## Protocol Section
### Identification Module
**NCT ID:** NCT01514279

**Acronym:** IMPACT

**Brief Title:** Ideas Moving Parents and Adolescents to Change Together (IMPACT)

**Official Title:** Targeting Obesity and Blood Pressure in Urban Youth(Consortium Title: Childhood Obesity Prevention and Treatment Research [COPTR] and Site Project Name IMPACT (Ideas Moving Parents and Adolescents to Change Together).

#### Organization Study ID Info
**ID:** IMPACT-1-5U01HL103622-02
#### Organization
**Class:** OTHER
**Full Name:** Case Western Reserve University
#### Secondary ID Infos
**ID:** 5U01HL103622-02
**Link:** https://reporter.nih.gov/quickSearch/5U01HL103622-02
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2017-01-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-08-25

**Type:** ACTUAL

**Last Update Submit Date:** 2020-08-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-01-21

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2020-08-25

**Type:** ACTUAL

**Results First Submit Date:** 2020-07-22

**Results First Submit QC Date:** 2020-08-13

#### Start Date
**Date:** 2011-02-01

**Type:** ACTUAL

**Status Verified Date:** 2020-08

#### Study First Post Date
**Date:** 2012-01-23
**Type:** ESTIMATED
**Study First Submit Date:** 2011-12-20
**Study First Submit QC Date:** 2012-01-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Heart, Lung, and Blood Institute (NHLBI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Case Western Reserve University

#### Responsible Party

**Investigator Affiliation:** Case Western Reserve University

**Investigator Full Name:** Elaine Borawski

**Investigator Title:** Angela Bowen Williamson Professor of Community Nutrition, Director, Prevention Research Center for Healthy Neighborhoods

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case Western Reserve/Cleveland's project is entitled "Targeting Obesity and Blood Pressure in Urban Youth". The site name is IMPACT (Ideas Moving Parents and Adolescents to Change Together).

The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only intervention (Tools4Change). In addition the study assesses the potential additional impact of a school-community based intervention on outcomes.

The project has two phases: a formative phase (including focus groups and a pilot) and the main trial. The main trial will take place over approximately four years.

**Detailed Description:** The IMPACT trial will involve a 3-arm randomized controlled trial of three behavioral and educational interventions: (1) HealthyCHANGE, a behavioral approach focusing on building skills and increasing intrinsic motivation (based on cognitive-behavioral theory with motivational interviewing components); (2) SystemCHANGE, an innovative behavioral approach focusing on system re-design of the family environment and daily routines (based on social-ecological and personal process improvement theories); and (3) education-only (representing usual care, called Tools4CHANGE).

In the main trial, approximately half of the children will also be in schools that take part in the We Run This City (WRTC)Marathon program, a school-based fitness program administered by the YMCA, and half will be in schools that do not take part in the WRTC program.

This study will assess the impact of the interventions on the main trial's (1) primary outcome, Change in Body Mass Index (BMI). (2) secondary outcomes including diet, physical activity, sedentary behavior, sleep, blood pressure, cardiovascular risk, body composition, fitness, and quality of life (3) mediators including : child's self-efficacy, social support, motivation, family problem solving ability, systems thinking, and self-regulation;(4) moderators including: socioeconomic status, demographic factors, environmental factors, personal and psychosocial characteristics of child and parent.

### Conditions Module

**Conditions:**

- Overweight

- Obese

**Keywords:**

- Overweight

- Obese

- Over Nutrition

- Nutrition Disorders

- Body weight

- Signs and Symptoms

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 360

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

**Intervention Names:**

- Behavioral: HealthyCHANGE

**Label:** HealthyCHANGE

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

**Intervention Names:**

- Behavioral: SystemCHANGE

**Label:** SystemCHANGE

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.

**Label:** Tools4CHANGE

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- HealthyCHANGE

**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.

**Name:** HealthyCHANGE

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- SystemCHANGE

**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.

**Name:** SystemCHANGE

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** BMI slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without BMI values post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Slope of Body Mass Index (BMI)

**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos

#### Secondary Outcomes

**Description:** Annualized change in calories per day.

Dietary intake slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Dietary Intake- Calories Per Day

**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos

**Description:** Annualized change in blood pressure measures using the slope of 3 year trajectory.

Blood pressure slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood pressure readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Blood Pressure

**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos

**Description:** Annualized change in physical activity measures of moderate to vigorous minutes per day and bed rest/sedentary minutes per day as measured by accelerometer.

Physical activity slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without accelerometer readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Physical Activity

**Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos]

**Description:** The results reflect the annualized change in adolescent sleep wake scale and pediatric daytime sleepiness scale. The items of the adolescent sleep wake scale are recoded to have a minimum of 0 and maximum value of 5, in which a higher scores for both the individual items and the overall sum score indicate a better outcome. The items of the pediatric daytime sleepiness are recoded to have a minimum of 0 and maximum value of 4, in which a lower score for both the individual items and the overall sum score indicates a better outcome.

Sleep slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without post-baseline measures. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Sleep

**Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos]

**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slopes of fasting glucose, HDL cholesterol, LDL cholesterol, and total cholesterol over 3 years reported.

**Measure:** Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol

**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos

**Description:** The annualized change in body composition measures over 3 years.

Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in slope of BMI percentile over time reported.

**Measure:** Body Composition- BMI Percentile

**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos

**Description:** The annualized change in pacer laps completed during PACER test over 3 years.

PACER test slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without PACER test measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Fitness

**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos

**Description:** The annualized change in perceived stress over 3 years. Participants are asked to rate individual scale items on their perception of how often they feel specific stressors on a scale from 0 (never) to 4 (very often). Individual scale items are summed for a total score. Higher scores indicate higher perceived frequency of stressors, therefore higher perceived stress. Outcomes are reported as the mean of the slope estimates for total perceived stress score over 3 years (from baseline to 36 months).

The perceived stress slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without stress scores post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Quality of Life- Perceived Stress

**Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos]

**Description:** The annualized change of percent of calories from fat over 3 years.

Percent calories from fat slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Dietary Intake- Percent Calories From Fat

**Time Frame:** Baseline, 12 months, 24 months, 36 months

**Description:** The annualized change in the number of fruit and vegetable servings per day over 3 years.

Serving slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Dietary Intake- Fruit and Vegetable Servings

**Time Frame:** Baseline, 12 months, 24 months, 36 months

**Description:** The annualized change in sodium intake (mg) per day over 3 years.

Sodium intake slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

**Measure:** Dietary Intake- Sodium

**Time Frame:** Baseline, 12 months, 24 months, 36 months

**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slope of glycated Hemoglobin A1c over 3 years reported.

**Measure:** Cardiometabolic Factors- Hemoglobin A1c

**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]

**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slope of high-sensitivity C-reactive protein over 3 years reported.

**Measure:** Cardiometabolic Factors- High-sensitivity C-reactive Protein

**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]

**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slope of insulin over 3 years reported.

**Measure:** Cardiometabolic Factors- Insulin

**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]

**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slope of HOMA-IR over 3 years reported.

**Measure:** Cardiometabolic Factors- HOMA-IR

**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]

**Description:** The annualized change in body composition measures over 3 years.

Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in slope of waist-to-height ratio over time reported. The weight-to-heigh ratio compares the child's waist circumference (cm) to their height (cm).

**Measure:** Body Composition- Waist-to-height Ratio

**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]

**Description:** The annualized change in body composition measures over 3 years.

Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in slope of waist circumference (cm) over time reported.

**Measure:** Body Composition- Waist Circumference

**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]

**Description:** The annualized change in body composition measures over 3 years.

Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in slope of body fat percentage over time reported. Body fat percentage calculated using Stevens equation.

**Measure:** Body Composition- Percent Body Fat

**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Students entering the 6th grade who are found at the standard school screenings to be overweight or obese
* (BMI 85th- 94th percentile or \> 95th percentile for age/sex respectively)

Exclusion Criteria:

* Taking medications that alter appetite or weight (e.g. glucocorticoids, metformin, insulin, Risperidone (Risperdal), Olanzapine (Zyprexa), Clozapine(Clozaril), Quetiapine (Seroquel), Ziprasidone (Geodon), Carbamazepine (Tegretol), Valproic acid (Depakote/Depakene/Depacon), Aripiprazole (Abilify), Orlistat (Xenical), Sibutramine (Meridia), Phentermine, Diethylproprion (Tenuate), Topirimate (Topamax), glitazones (thiazolidinediones)
* Inability to understand English
* Stage 2 hypertension or stage 1 hypertension with end organ damage (left ventricular hypertrophy, microalbuminuria)
* Severe behavioral problems that preclude group participation (as reported by parent/guardian)
* Child involvement in another weight management program
* Family expectation to move from the region within 1 year
* The presence of a known medical condition that itself causes obesity (e.g., Prader-Willi syndrome) or interfere with HbA1C ( sickle cell disease)

**Maximum Age:** 15 Years

**Minimum Age:** 11 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cleveland

**Country:** United States

**Facility:** Case Western Reserve University

**State:** Ohio

**Zip:** 44106

#### Overall Officials

**Official 1:**

**Affiliation:** Case Western Reserve University

**Name:** Elaine A Borawski, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Case Western Reserve University

**Name:** Shirley M Moore, RN, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Conducted in conjunction with the Research Coordinating Unit (UNC Chapel Hill) of the COPTR Consortium.

**IPD Sharing:** YES

### References Module

#### References

**Citation:** Moore SM, Borawski EA, Cuttler L, Ievers-Landis CE, Love TE. IMPACT: a multi-level family and school intervention targeting obesity in urban youth. Contemp Clin Trials. 2013 Nov;36(2):574-86. doi: 10.1016/j.cct.2013.08.009. Epub 2013 Sep 2.

**PMID:** 24008055

**Citation:** JaKa MM, Wood C, Veblen-Mortenson S, Moore SM, Matheson D, Stevens J, Atkins L, Michie S, Adegbite-Adeniyi C, Olayinka O, Po'e EK, Kelly AM, Nicastro H, Bangdiwala SI, Barkin SL, Pratt C, Robinson TN, Sherwood NE. Applying the Behavior Change Technique Taxonomy to Four Multicomponent Childhood Obesity Interventions. West J Nurs Res. 2021 May;43(5):468-477. doi: 10.1177/0193945920954782. Epub 2020 Sep 10.

**PMID:** 32909523

**Citation:** Truesdale KP, Matheson DM, JaKa MM, McAleer S, Sommer EC, Pratt CA. Baseline diet quality of predominantly minority children and adolescents from households characterized by low socioeconomic status in the Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. BMC Nutr. 2019 Sep 9;5:38. doi: 10.1186/s40795-019-0302-y. eCollection 2019.

**PMID:** 32153951

**Citation:** Cui Z, Truesdale KP, Robinson TN, Pemberton V, French SA, Escarfuller J, Casey TL, Hotop AM, Matheson D, Pratt CA, Lotas LJ, Po'e E, Andrisin S, Ward DS. Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium. Trials. 2019 May 28;20(1):296. doi: 10.1186/s13063-019-3418-0.

**PMID:** 31138278

**Citation:** Moore SM, Borawski EA, Love TE, Jones S, Casey T, McAleer S, Thomas C, Adegbite-Adeniyi C, Uli NK, Hardin HK, Trapl ES, Plow M, Stevens J, Truesdale KP, Pratt CA, Long M, Nevar A. Two Family Interventions to Reduce BMI in Low-Income Urban Youth: A Randomized Trial. Pediatrics. 2019 Jun;143(6):e20182185. doi: 10.1542/peds.2018-2185.

**PMID:** 31126971

## Document Section

### Large Document Module

#### Large Docs

- Date: 2012-03-30

- Filename: Prot_SAP_ICF_000.pdf

- Has ICF: True

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

- Size: 1406255

- Type Abbrev: Prot_SAP_ICF

- Upload Date: 2020-07-22T11:59

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M30155

- Name: Pediatric Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000050177

- Term: Overweight

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** HealthyCHANGE

**Deaths Num At Risk:** 118

**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.

**ID:** EG000

**Other Num at Risk:** 118

**Serious Number Affected:** 30

**Serious Number At Risk:** 118

**Title:** HealthyCHANGE

**Group ID:** EG001

**Title:** SystemCHANGE

**Deaths Num At Risk:** 123

**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.

**ID:** EG001

**Other Num at Risk:** 123

**Serious Number Affected:** 29

**Serious Number At Risk:** 123

**Title:** SystemCHANGE

**Group ID:** EG002

**Title:** Tools4CHANGE

**Deaths Num At Risk:** 119

**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.

**ID:** EG002

**Other Num at Risk:** 119

**Serious Number Affected:** 28

**Serious Number At Risk:** 119

**Title:** Tools4CHANGE

**Frequency Threshold:** 5

#### Serious Events

**Term:** Cardiac event

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Any event related to the cardiovascular system

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 118

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 123

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 3

**Num At Risk:** 119

**Num Events:** 3

**Term:** Diabetic event

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Any event related to diabetes

**Organ System:** Endocrine disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 118

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 123

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 119

**Term:** Diabetes-related complications

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 118

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 123

**Group ID:** EG002

**Num At Risk:** 119

**Term:** Surgery

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 118

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 123

**Group ID:** EG002

**Num At Risk:** 119

**Term:** Cancer diagnosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 118

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 123

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 119

**Term:** Hospitalization

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 118

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 123

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 119

**Term:** Hospitalization

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 118

**Num Events:** 5

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 123

**Num Events:** 3

**Group ID:** EG002

**Num Affected:** 4

**Num At Risk:** 119

**Num Events:** 4

**Term:** Immune system disorder diagnosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 118

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 123

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 119

**Term:** Immune system disorder complications

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 118

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 123

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 119

**Term:** Event resulting in injury or poisoning

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Non-study related events only

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 118

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 123

**Num Events:** 2

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 119

**Num Events:** 2

**Term:** Nervous system event

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 118

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 123

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 119

**Num Events:** 2

**Term:** Childbirth

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Pregnancy, puerperium and perinatal conditions

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 118

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 123

**Num Events:** 3

**Group ID:** EG002

**Num Affected:** 4

**Num At Risk:** 119

**Num Events:** 4

**Term:** Pregnancy complications

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Pregnancy, puerperium and perinatal conditions

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 118

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 123

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 119

**Num Events:** 2

**Term:** Psychiatric event

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 118

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 123

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 119

**Num Events:** 1

**Term:** Event related to reproductive system

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 118

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 123

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 119

**Term:** Respiratory event

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 118

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 123

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 3

**Num At Risk:** 119

**Num Events:** 3

**Term:** Housefire

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Social circumstances

##### Stats

**Group ID:** EG000

**Num At Risk:** 118

**Group ID:** EG001

**Num At Risk:** 123

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 119

**Num Events:** 2

**Term:** Surgery

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

##### Stats

**Group ID:** EG000

**Num Affected:** 7

**Num At Risk:** 118

**Num Events:** 7

**Group ID:** EG001

**Num Affected:** 8

**Num At Risk:** 123

**Num Events:** 8

**Group ID:** EG002

**Num Affected:** 5

**Num At Risk:** 119

**Num Events:** 5

**Time Frame:** 3 years

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 118

**Group ID:** BG001

**Value:** 123

**Group ID:** BG002

**Value:** 119

**Group ID:** BG003

**Value:** 360

**Units:** Participants

### Group

**ID:** BG000

**Title:** HealthyCHANGE

**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.

### Group

**ID:** BG001

**Title:** SystemCHANGE

**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.

### Group

**ID:** BG002

**Title:** Tools4CHANGE

**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 0.56

**Value:** 11.58

#### Measurement

**Group ID:** BG001

**Spread:** 0.59

**Value:** 11.59

#### Measurement

**Group ID:** BG002

**Spread:** 0.56

**Value:** 11.51

#### Measurement

**Group ID:** BG003

**Spread:** 0.57

**Value:** 11.56

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 66

#### Measurement

**Group ID:** BG001

**Value:** 73

#### Measurement

**Group ID:** BG002

**Value:** 69

#### Measurement

**Group ID:** BG003

**Value:** 208

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 52

#### Measurement

**Group ID:** BG001

**Value:** 50

#### Measurement

**Group ID:** BG002

**Value:** 50

#### Measurement

**Group ID:** BG003

**Value:** 152

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 14

**Category Title:** Non-Hispanic White

#### Measurement

**Group ID:** BG000

**Value:** 91

#### Measurement

**Group ID:** BG001

**Value:** 92

#### Measurement

**Group ID:** BG002

**Value:** 93

#### Measurement

**Group ID:** BG003

**Value:** 276

**Category Title:** Non-Hispanic Black

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 24

#### Measurement

**Group ID:** BG002

**Value:** 18

#### Measurement

**Group ID:** BG003

**Value:** 59

**Category Title:** Hispanic

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 8

**Category Title:** Multi-racial

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 3

**Category Title:** Other

**Class Title:** Child's Race/Ethnicity

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 118

#### Measurement

**Group ID:** BG001

**Value:** 123

#### Measurement

**Group ID:** BG002

**Value:** 119

#### Measurement

**Group ID:** BG003

**Value:** 360

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 4.78

**Value:** 27.25

#### Measurement

**Group ID:** BG001

**Spread:** 5.12

**Value:** 27.36

#### Measurement

**Group ID:** BG002

**Spread:** 4.71

**Value:** 26.80

#### Measurement

**Group ID:** BG003

**Spread:** 4.87

**Value:** 27.14

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body mass index
**Unit of Measure:** kg/m^2
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** exb11@case.edu
**Organization:** School of Medicine, Case Western Reserve University
**Phone:** 216)368-1024
**Title:** Dr. Elaine Borawski, PhD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.363
- **Upper Limit:** 
- **Value:** 0.821
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.129
- **Upper Limit:** 
- **Value:** 1.083
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.318
- **Upper Limit:** 
- **Value:** 0.952
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 226.65
- **Upper Limit:** 
- **Value:** 12.49
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 211.04
- **Upper Limit:** 
- **Value:** 6.99
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 250.44
- **Upper Limit:** 
- **Value:** 24.03
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.319
- **Upper Limit:** 
- **Value:** 1.245
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.075
- **Upper Limit:** 
- **Value:** 1.130
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.787
- **Upper Limit:** 
- **Value:** 0.886
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.796
- **Upper Limit:** 
- **Value:** -0.136
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.726
- **Upper Limit:** 
- **Value:** -0.074
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.378
- **Upper Limit:** 
- **Value:** -0.162
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.206
- **Upper Limit:** 
- **Value:** -1.450
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.063
- **Upper Limit:** 
- **Value:** -2.044
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 8.095
- **Upper Limit:** 
- **Value:** -2.028
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.228
- **Upper Limit:** 
- **Value:** -2.335
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.063
- **Upper Limit:** 
- **Value:** -2.044
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 6.645
- **Upper Limit:** 
- **Value:** -2.132
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 10.123
- **Upper Limit:** 
- **Value:** -3.370
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.486
- **Upper Limit:** 
- **Value:** -4.619
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 8.493
- **Upper Limit:** 
- **Value:** -3.523
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 16.365
- **Upper Limit:** 
- **Value:** 10.501
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 14.561
- **Upper Limit:** 
- **Value:** 13.052
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 16.961
- **Upper Limit:** 
- **Value:** 11.022
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.937
- **Upper Limit:** 
- **Value:** -1.061
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 9.755
- **Upper Limit:** 
- **Value:** -1.552
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 7.749
- **Upper Limit:** 
- **Value:** -1.184
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.350
- **Upper Limit:** 
- **Value:** -0.239
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.618
- **Upper Limit:** 
- **Value:** -0.361
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.089
- **Upper Limit:** 
- **Value:** -0.273
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.864
- **Upper Limit:** 
- **Value:** -0.146
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.805
- **Upper Limit:** 
- **Value:** -0.520
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.135
- **Upper Limit:** 
- **Value:** -0490
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.433
- **Upper Limit:** 
- **Value:** -0.300
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.526
- **Upper Limit:** 
- **Value:** -0.600
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.906
- **Upper Limit:** 
- **Value:** -0.385
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.915
- **Upper Limit:** 
- **Value:** -1.449
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 7.295
- **Upper Limit:** 
- **Value:** -1.970
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 6.645
- **Upper Limit:** 
- **Value:** -2.357
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.500
- **Upper Limit:** 
- **Value:** -2.409
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.280
- **Upper Limit:** 
- **Value:** -3.651
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 7.201
- **Upper Limit:** 
- **Value:** -2.94
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.821
- **Upper Limit:** 
- **Value:** -1.375
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.552
- **Upper Limit:** 
- **Value:** -0.258
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.225
- **Upper Limit:** 
- **Value:** -1.082
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.640
- **Upper Limit:** 
- **Value:** 1.084
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.663
- **Upper Limit:** 
- **Value:** 0.533
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.491
- **Upper Limit:** 
- **Value:** 1.715
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.620
- **Upper Limit:** 
- **Value:** 0.313
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.769
- **Upper Limit:** 
- **Value:** -0.049
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.491
- **Upper Limit:** 
- **Value:** -0.026
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.905
- **Upper Limit:** 
- **Value:** 0.139
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.589
- **Upper Limit:** 
- **Value:** -0.050
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.360
- **Upper Limit:** 
- **Value:** -0.055
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.239
- **Upper Limit:** 
- **Value:** -0.061
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.234
- **Upper Limit:** 
- **Value:** -0.050
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.360
- **Upper Limit:** 
- **Value:** -0.055
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.276
- **Upper Limit:** 
- **Value:** 0.013
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.263
- **Upper Limit:** 
- **Value:** 0.008
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.253
- **Upper Limit:** 
- **Value:** -0.008
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 425.79
- **Upper Limit:** 
- **Value:** -0.42
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 409.34
- **Upper Limit:** 
- **Value:** 26.46
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 446.28
- **Upper Limit:** 
- **Value:** 39.15
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.210
- **Upper Limit:** 
- **Value:** -0.040
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.304
- **Upper Limit:** 
- **Value:** -0.021
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.093
- **Upper Limit:** 
- **Value:** -0.017
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.163
- **Upper Limit:** 
- **Value:** -0.013
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.141
- **Upper Limit:** 
- **Value:** -0.002
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.123
- **Upper Limit:** 
- **Value:** -0.0185
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.761
- **Upper Limit:** 
- **Value:** 0.772
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.875
- **Upper Limit:** 
- **Value:** 0.406
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 4.568
- **Upper Limit:** 
- **Value:** 0.228
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.003
- **Upper Limit:** 
- **Value:** 0.032
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.281
- **Upper Limit:** 
- **Value:** 0.037
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 1.009
- **Upper Limit:** 
- **Value:** 0.004
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.023
- **Upper Limit:** 
- **Value:** -0.003
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.017
- **Upper Limit:** 
- **Value:** 0.002
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.020
- **Upper Limit:** 
- **Value:** -0.001
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.584
- **Upper Limit:** 
- **Value:** 1.814
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.839
- **Upper Limit:** 
- **Value:** 2.339
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.288
- **Upper Limit:** 
- **Value:** 2.200
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.376
- **Upper Limit:** 
- **Value:** -0.246
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.889
- **Upper Limit:** 
- **Value:** 0.299
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.170
- **Upper Limit:** 
- **Value:** -0.044
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** BMI slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without BMI values post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos
**Title:** Slope of Body Mass Index (BMI)
**Type:** PRIMARY
**Unit of Measure:** kg/m^2/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 2
**Description:** Annualized change in calories per day.

Dietary intake slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos
**Title:** Dietary Intake- Calories Per Day
**Type:** SECONDARY
**Unit of Measure:** kcal/d/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 3
**Description:** Annualized change in blood pressure measures using the slope of 3 year trajectory.

Blood pressure slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood pressure readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos
**Title:** Blood Pressure
**Type:** SECONDARY
**Unit of Measure:** mmHg/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 4
**Description:** Annualized change in physical activity measures of moderate to vigorous minutes per day and bed rest/sedentary minutes per day as measured by accelerometer.

Physical activity slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without accelerometer readings post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos]
**Title:** Physical Activity
**Type:** SECONDARY
**Unit of Measure:** minutes/day/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 5
**Description:** The results reflect the annualized change in adolescent sleep wake scale and pediatric daytime sleepiness scale. The items of the adolescent sleep wake scale are recoded to have a minimum of 0 and maximum value of 5, in which a higher scores for both the individual items and the overall sum score indicate a better outcome. The items of the pediatric daytime sleepiness are recoded to have a minimum of 0 and maximum value of 4, in which a lower score for both the individual items and the overall sum score indicates a better outcome.

Sleep slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without post-baseline measures. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos]
**Title:** Sleep
**Type:** SECONDARY
**Unit of Measure:** score on a scale/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 6
**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slopes of fasting glucose, HDL cholesterol, LDL cholesterol, and total cholesterol over 3 years reported.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos
**Title:** Cardiometabolic Factors- Fasting Glucose, HDL Cholesterol, LDL Cholesterol, Total Cholesterol
**Type:** SECONDARY
**Unit of Measure:** mg/dL/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 7
**Description:** The annualized change in body composition measures over 3 years.

Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in slope of BMI percentile over time reported.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos
**Title:** Body Composition- BMI Percentile
**Type:** SECONDARY
**Unit of Measure:** BMI percentile/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 8
**Description:** The annualized change in pacer laps completed during PACER test over 3 years.

PACER test slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without PACER test measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 mos, 24 mos and 36 mos
**Title:** Fitness
**Type:** SECONDARY
**Unit of Measure:** laps completed/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 9
**Description:** The annualized change in perceived stress over 3 years. Participants are asked to rate individual scale items on their perception of how often they feel specific stressors on a scale from 0 (never) to 4 (very often). Individual scale items are summed for a total score. Higher scores indicate higher perceived frequency of stressors, therefore higher perceived stress. Outcomes are reported as the mean of the slope estimates for total perceived stress score over 3 years (from baseline to 36 months).

The perceived stress slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without stress scores post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos and 36 mos]
**Title:** Quality of Life- Perceived Stress
**Type:** SECONDARY
**Unit of Measure:** scores on a scale/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 10
**Description:** The annualized change of percent of calories from fat over 3 years.

Percent calories from fat slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 months, 24 months, 36 months
**Title:** Dietary Intake- Percent Calories From Fat
**Type:** SECONDARY
**Unit of Measure:** percent/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 11
**Description:** The annualized change in the number of fruit and vegetable servings per day over 3 years.

Serving slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 months, 24 months, 36 months
**Title:** Dietary Intake- Fruit and Vegetable Servings
**Type:** SECONDARY
**Unit of Measure:** number of servings/day/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 12
**Description:** The annualized change in sodium intake (mg) per day over 3 years.

Sodium intake slope (trajectory over 3 years) was created for each participant with outcomes multiply imputed for children without diet recall data post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 12 months, 24 months, 36 months
**Title:** Dietary Intake- Sodium
**Type:** SECONDARY
**Unit of Measure:** mg/day/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 13
**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slope of glycated Hemoglobin A1c over 3 years reported.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]
**Title:** Cardiometabolic Factors- Hemoglobin A1c
**Type:** SECONDARY
**Unit of Measure:** % glycated/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 14
**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slope of high-sensitivity C-reactive protein over 3 years reported.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]
**Title:** Cardiometabolic Factors- High-sensitivity C-reactive Protein
**Type:** SECONDARY
**Unit of Measure:** mg/L/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 15
**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slope of insulin over 3 years reported.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]
**Title:** Cardiometabolic Factors- Insulin
**Type:** SECONDARY
**Unit of Measure:** uU/mL/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 16
**Description:** Annualized change in various cardiometabolic factor measures over 3 years.

Cardiometabolic factor slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without blood draws post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in the slope of HOMA-IR over 3 years reported.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]
**Title:** Cardiometabolic Factors- HOMA-IR
**Type:** SECONDARY
**Unit of Measure:** score on a scale/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 17
**Description:** The annualized change in body composition measures over 3 years.

Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in slope of waist-to-height ratio over time reported. The weight-to-heigh ratio compares the child's waist circumference (cm) to their height (cm).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]
**Title:** Body Composition- Waist-to-height Ratio
**Type:** SECONDARY
**Unit of Measure:** ratio/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 18
**Description:** The annualized change in body composition measures over 3 years.

Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in slope of waist circumference (cm) over time reported.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]
**Title:** Body Composition- Waist Circumference
**Type:** SECONDARY
**Unit of Measure:** cm/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
#### Outcome Measure 19
**Description:** The annualized change in body composition measures over 3 years.

Body composition slopes (trajectory over 3 years) were created for each participant with outcomes multiply imputed for children without body composition measurements post-baseline. An F test with two numerator degrees of freedom was used to test for between-group differences using an alpha of .05.

Change in slope of body fat percentage over time reported. Body fat percentage calculated using Stevens equation.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** [Baseline, 12 mos, 24 mos, 36 mos]
**Title:** Body Composition- Percent Body Fat
**Type:** SECONDARY
**Unit of Measure:** percent/year
##### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG000
**Title:** HealthyCHANGE
##### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** OG001
**Title:** SystemCHANGE
##### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** OG002
**Title:** Tools4CHANGE
### Participant Flow Module
#### Group
**Description:** Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

HealthyCHANGE: Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** FG000
**Title:** HealthyCHANGE
#### Group
**Description:** Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines

SystemCHANGE: Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.

It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls.
**ID:** FG001
**Title:** SystemCHANGE
#### Group
**Description:** In contrast to the behavioral arms, youths with their parent(s)/guardian randomized to this group will have one 60-minute face-to-face meeting at initiation of the study with a dietitian who is also trained in recommendations for exercise and sedentary behavior.
**ID:** FG002
**Title:** Tools4CHANGE
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 118
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 123
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 119
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 107
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 110
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 114
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 11
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 5
**Recruitment Details:** Participants were recruited between May 2012 and January 2014 as part of an existing BMI and blood pressure screening program in the local school district. Participants were randomly assigned to 1 of 3 intervention study arms within 37 days of the baseline clinical visit once recruited.
**Has Results:** True