Childhood Obesity Management Using Innovative Digital Technology

NCT06777888 | Active Not Recruiting

• 2 other identifiers: H20-00759PJT - 169013
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The project will evaluate the short- and long-term effects of a 10-week Family Healthy Living Program (FHLP). The program is designed for families with children ages 8-12 years old who are at risk for being above a healthy weight and who would like support with healthy living habits such as physical activity and healthy eating. Families will participate together, with both parents and children being involved in the program. FHLP participants will receive 9 weekly 2-hour online group sessions with a facilitation team as well as additional web-based resources. They will be compared to a control group of participating families who will be offered only the self-guided web-based resources. This will help us see the impact of offering facilitated FHLP group sessions versus only offering resources online. The FHLP is 10 weeks long, but participants will be followed for 12 months in total so that researchers can look at the long-term impact of participation. All participating families from both groups will be asked to complete surveys and provide child height and weight measurements at four timepoints: before beginning the program, immediately after completing the program, at 6-months post-program, and at 12-months post-program. Children will also be given FitBit activity watches to measure their daily step counts at each timepoint. Researchers will compare survey responses, child growth patterns, and FitBit step counts between the FHLP participants and the control group to see whether participating in the FHLP helps families improve their healthy living habits more than only offering a similar curriculum of healthy living resources online for families to access on their own.

Conditions

Obesity Prevention; Child Behaviour; Health Behaviour Change; Obesity and Overweight; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Child BMI Z-scores

  Participants will be asked to self-report measurements of each child's height, weight and age to calculate BMI. Children's BMI z-scores will be calculated based on the World Health Organization criteria. This data will be collected at baseline, 10-week, 6-month and 12-month assessments.

  From enrollment to 12 month follow-up

Secondary Outcomes (2)

• Improving lifestyle behaviours and quality of life in children

  From enrollment to 12 month follow-up

• Child physical activity measurements

  From enrollment to 12 month follow-up

Study Arms (2)

Family Healthy Living Program Intervention Group

EXPERIMENTAL

Behavioral: Family Healthy Living Program weekly group sessions

Self-Guided Web Only Group

OTHER

Behavioral: Self-guided Web Portal Resources Only

Interventions

Family Healthy Living Program weekly group sessions BEHAVIORAL

Children aged 8-12 and at least one caregiver will meet for 9 weekly virtual group intervention sessions (2 hours per session) with program facilitators and will also have access to a virtual Q and A session and up to 3 virtual cooking classes with a Registered Dietician. During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions.

Also known as: Family Healthy Living Intervention, Early Intervention Program, Generation Health Community

Family Healthy Living Program Intervention Group

Self-guided Web Portal Resources Only BEHAVIORAL

Children aged 8-12 and at least one caregiver will be offered access to digital educational content and downloadable resources on topics such as physical activity, healthy eating, and positive mental well-being.

Self-Guided Web Only Group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children must have a BMI ≥ 85th percentile for age and sex.

You may not qualify if:

• Children below the 85th percentile BMI.
• The inability to communicate (speak, read, and write) in English.
• Any conditions that prevent children from being physically active.

Sponsors & Collaborators

• University of Victoria: lead

Study Sites (1)

University of Victoria

Victoria, British Columbia, V8P 5C2, Canada

Location

Related Publications (1)

• Jantzen RR, Naylor PJ, Strange K, Ball GDC, Masse LC, Rhodes RE, Zhang X, Nolan RP, Zheng S, Rac V, Liu S. Evaluating the Effectiveness of a Family-Based Lifestyle Intervention for Managing Childhood Overweight: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 14;14:e76837. doi: 10.2196/76837.

  PMID: 41085996 DERIVED

MeSH Terms

Conditions

Obesity; Overweight; Motor Activity

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Sam Liu

  University of Victoria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: January 16, 2025
• Study Start: December 15, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)