## Protocol Section
### Identification Module
**NCT ID:** NCT06432790

**Acronym:** CHAMPION

**Brief Title:** Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline

**Official Title:** Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline (CHAMPION)

#### Organization Study ID Info
**ID:** 2022A018209
#### Organization
**Class:** OTHER
**Full Name:** Massachusetts General Hospital
#### Secondary ID Infos
**Domain:** Patient-Centered Outcomes Research Institute (PCORI)
**ID:** TE-2022C3-30362
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2028-07-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** American Academy of Pediatrics

#### Lead Sponsor

**Class:** OTHER

**Name:** Massachusetts General Hospital

#### Responsible Party

**Investigator Affiliation:** Massachusetts General Hospital

**Investigator Full Name:** Lauren G. Fiechtner, M.D.

**Investigator Title:** Assistant Professor of Pediatrics

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this study is to evaluate the effectiveness of CHAMPION, a primary care-based intervention to address childhood obesity and asthma, and test the effectiveness of a telehealth-only version of the program. Intensive Health Behavior and Lifestyle Treatment (IHBLT), when delivered via telehealth vs. in-person among children with overweight or obesity and persistent asthma.

**Detailed Description:** This study will evaluate the comparative effectiveness of 1) telehealth delivery of CHAMPION vs. 2) in-person (standard of care) delivery of CHAMPION in a two-arm, individually randomized non-inferiority trial among 500 children. Obesity and asthma are two leading chronic diseases in children, and CHAMPION is an integration of the Healthy Weight Clinic (HWC) and pediatric Asthma Population Health Management Programming at Mass General Brigham. This study will address how to improve access to effective treatments consistent with United States Preventive Services Task Force and American Academy of Pediatrics guidelines that manage asthma and obesity concurrently in primary care among lower income diverse populations

### Conditions Module

**Conditions:**

- Overweight, Childhood

- Obesity, Childhood

- Asthma in Children

**Keywords:**

- telehealth

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 500

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** * Intensive 0-6 months: 1 individual visit monthly (virtual), 1 group visit monthly (virtual)
* Maintenance 6-12 months: 1 individual visit monthly (virtual), 2 health coaching calls per month

**Intervention Names:**

- Behavioral: CHAMPION

**Label:** CHAMPION via Telehealth

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** * Intensive 0-6 months: 1 individual visit monthly (in-person), 1 group visit monthly (in-person)
* Maintenance 6-12 months: 1 individual visit monthly (in-person), 2 health coaching calls per month

**Intervention Names:**

- Behavioral: CHAMPION

**Label:** CHAMPION In-Person

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CHAMPION In-Person

- CHAMPION via Telehealth

**Description:** The CHAMPION program is an intensive health behavior and lifestyle treatment (IHBLT), formed through the integration of the Healthy Weight Clinic IHBLT and with MGB's pediatric Asthma Population Health Management Program. It consists of 30 hours of contact time with the CHAMPION team (physician, dietician, community health worker), consistent with the USPSTF and AAP recommendations, monthly individual clinic visits with the team (in person or virtual, per randomization), health coaching calls with a community health worker and/or registered dietician, monthly group sessions (in the first six months), and educational materials for families that reinforce healthy lifestyle behaviors and provide self-management education.

**Name:** CHAMPION

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Measured as BMI based on child height and weight

**Measure:** Change in Child BMI

**Time Frame:** 0-12 months

**Description:** Measured as BMI based on child height and weight, and derived from CDC growth curves accounting for child age and sex

**Measure:** Change in Child BMI z-score

**Time Frame:** 0-12 months

**Description:** Per Asthma Control Test

**Measure:** Change in Asthma Control Test

**Time Frame:** 0-12 months

**Description:** Per response to caregiver-proxy survey

**Measure:** Change in Asthma and Obesity Specific Quality of Life

**Time Frame:** 0-12 months

#### Secondary Outcomes

**Description:** Diet quality per Primescreen, via caregiver-proxy survey

**Measure:** Change in Child Diet Quality

**Time Frame:** 0-12 months

**Description:** Hours of sleep, via caregiver-proxy survey

**Measure:** Change in Child Average Hours of Sleep

**Time Frame:** 0-12 months

**Description:** Days physically active for at least 60 minutes per day, via caregiver-proxy survey

**Measure:** Change in Child Average Days of Physical Activity

**Time Frame:** 0-12 months

**Description:** Hours of sedentary screen time, via caregiver-proxy survey

**Measure:** Change in Child Average Hours of Screen Time

**Time Frame:** 0-12 months

**Description:** Per response to caregiver-proxy survey

**Measure:** Asthma-related healthcare utilization

**Time Frame:** 0-12 months

**Description:** Per response to caregiver-proxy survey

**Measure:** Change in perceived stress (caregiver)

**Time Frame:** 0-12 months

**Description:** Per response to caregiver-proxy survey

**Measure:** Family-centered care assessment

**Time Frame:** 12 months

**Description:** Per response to caregiver-proxy survey

**Measure:** Telehealth satisfaction

**Time Frame:** 12 months

**Description:** Per response to caregiver-proxy survey

**Measure:** Barriers to program attendance

**Time Frame:** 12 months

**Description:** Per response to caregiver-proxy survey

**Measure:** Change in disordered eating symptoms

**Time Frame:** 0-12 months

### Eligibility Module

**Eligibility Criteria:** Caregiver-proxies will be 18 years old or older, English or Spanish speaking, and a primary caregiver of a child meeting the following criteria:

Inclusion criteria

* Age 6-17.9 years at time of screening
* BMI ≥ 85th percentile
* Asthma diagnosis, per child's EHR documentation or caregiver report

Exclusion criteria

* Diagnosis of anorexia nervosa, per child's EHR or caregiver report
* Pregnant, per child's EHR
* Plan to change pediatricians in the next year, per caregiver report
* Opted out of research, per child's EHR
* Sibling currently enrolled in the research trial, per enrollment log or caregiver report

**Maximum Age:** 17 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lfiechtner@mgb.org

**Name:** Lauren Fiechtner, MD

**Phone:** 617-726-8705

**Role:** CONTACT

**Contact 2:**

**Email:** skelly45@mgh.harvard.edu

**Name:** Sheila Kelly, MPH

**Role:** CONTACT

### IPD Sharing Statement Module

**Description:** The funder, PCORI, requires data to be deposited into the Patient Centered Outcomes Data Repository/University of Michigan ICPSR.

**Info Types:**

- STUDY_PROTOCOL

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** Data will be deposited after study completion.

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

- ID: D000009765

- Term: Obesity

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M26186

- Name: Overweight

- Relevance: HIGH

- As Found: Overweight

- ID: M30155

- Name: Pediatric Obesity

- Relevance: HIGH

- As Found: Overweight, Childhood

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

- ID: D000050177

- Term: Overweight

- ID: D000063766

- Term: Pediatric Obesity

### Misc Info Module

- Version Holder: 2024-05-31
