## Protocol Section
### Identification Module
**NCT ID:** NCT06434259

**Brief Title:** Evaluation of Long-term Digital Childhood Obesity Treatment

**Official Title:** Long-term Results of an Interactive Mobile Health Support System and Daily Home-weighing as an add-on to Pediatric Obesity Lifestyle Treatment: A 3-year Pragmatic Clinical Trial

#### Organization Study ID Info
**ID:** Evira100
#### Organization
**Class:** OTHER
**Full Name:** Karolinska Institutet
### Status Module
#### Completion Date
**Date:** 2022-09-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-09-30

**Type:** ACTUAL

#### Start Date
**Date:** 2018-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Karolinska Institutet

#### Responsible Party

**Investigator Affiliation:** Karolinska Institutet

**Investigator Full Name:** Pernilla Danielsson

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study aims to evaluate if a web-based digital support system aiming to replacing or complement standardized pediatric behavioural obesity treatment. The hypothesis is that a digital system of communication between the family and the clinic can generate improved treatment results (change in BMI SDS) and reduce the number of missed visits.

**Detailed Description:** Childhood obesity treatment is time consuming for both the health care system, and for the involved families. There is an association between the intensity and the outcome of treatment.

In this study all children who start treatment for childhood obesity will use a digital support system as a complement to behavioral treatment. The digital support system includes daily weighing on scales that do not show any digits, linked to a mobile app where weight development is shown as a moving average in the form of BMI standard deviation score (SDS). The app also provides an individual target curve visualizing the expected weight journey. Weight in growing children is complex to interpret why BMI SDS is used. Objective data from scale are automatically transferred to the database and the clinic and the family have direct contact with the clinic via the app.

The present study is a continuation of the investigators previous one-year study, Clinicaltrials.gov ID: NCT04323215. In this follow-up study, the investigators aim to assess the treatment outcomes over a three-year period.

The evaluation will be carried out on 107 children who underwent digi-physical treatment for three years. The results will be compared with a matched control group (n=321) from the Swedish childhood obesity treatment register, BORIS.

### Conditions Module

**Conditions:**

- Childhood Obesity

- Treatment Adherence

**Keywords:**

- Mobile Health

- Support System

- Behavioral Treatment

- Self-Monitoring

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 428

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Usual care (behavioral treatment) plus the support system for self- monitoring of weight and communication with the clinic during three years of treatment.

**Intervention Names:**

- Device: Digi-physical support system

**Label:** Digi-physical treatment group

#### Arm Group 2

**Description:** Children treated with usual care according to regular treatment routines registered in the Swedish childhood obesity treatment register, BORIS

**Label:** Control group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Digi-physical treatment group

**Description:** A support system named Evira will be used to provide behavioral treatment.

**Name:** Digi-physical support system

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Measured by BMI standard deviation score. Digi-physical group vs. control group

**Measure:** Change in degree of obesity

**Time Frame:** From start of treatment to three years follow-up

#### Secondary Outcomes

**Description:** Number of weighings/week

**Measure:** The use of the support system - weighings

**Time Frame:** From start of treatment to three years follow-up

**Description:** Number text messages/week

**Measure:** The use of the support system - text messages

**Time Frame:** From start of treatment to three years follow-up

**Description:** Visits to the clinic. Digi-physical group vs. control group

**Measure:** Number of physical visits

**Time Frame:** From start of treatment to three years follow-up

**Description:** Visits to the clinic. Digi-physical group vs. control group

**Measure:** Number of cancelation of physical visits

**Time Frame:** From start of treatment to three years follow-up

**Description:** Visits to the clinic. Digi-physical group vs. control group

**Measure:** Number of patients not showing up to physical visit

**Time Frame:** From start of treatment to three years follow-up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Obesity according to International Obesity Task Force (IOTF)

Exclusion Criteria:

* None

**Maximum Age:** 18 Years

**Minimum Age:** 4 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** All children who start treatment for childhood obesity at Martina children Hospital will use a digital support system as a complement to behavioral treatment. 107 children in the digit-physical group and 321 children in the control group, aged 4-17.9 years, will be included.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stockholm

**Country:** Sweden

**Facility:** Childrens Hospital Martina

**Zip:** 114 28

#### Overall Officials

**Official 1:**

**Affiliation:** Karolinska Institutet, CLINTEC, Division of pediatrics

**Name:** Pernilla Danielsson Liljeqvist, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Hagman E, Johansson L, Kollin C, Marcus E, Drangel A, Marcus L, Marcus C, Danielsson P. Effect of an interactive mobile health support system and daily weight measurements for pediatric obesity treatment, a 1-year pragmatical clinical trial. Int J Obes (Lond). 2022 Aug;46(8):1527-1533. doi: 10.1038/s41366-022-01146-8. Epub 2022 May 31.

**PMID:** 35641569

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M30155

- Name: Pediatric Obesity

- Relevance: HIGH

- As Found: Childhood Obesity

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

- ID: D000063766

- Term: Pediatric Obesity

### Misc Info Module

- Version Holder: 2024-05-31
