Childhood Obesity Management Using Innovative Digital Technology

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Obesity Prevention; Child Behaviour; Health Behaviour Change; Obesity and Overweight
• Intervention / Treatment: Behavioral: Family Healthy Living Program weekly group sessions; Behavioral: Self-guided Web Portal Resources Only

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8P 5C2
      • University of Victoria

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children must be aged 8-12 years with at least one primary caregiver who agrees to participate with them. More than one child per parent will be able to participate if the child meets the inclusion criteria.
• Children must have a BMI ≥ 85th percentile for age and sex.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family Healthy Living Program Intervention Group	Behavioral: Family Healthy Living Program weekly group sessions; 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.; Other Names: Family Healthy Living Intervention; Early Intervention Program; Generation Health Community
Other: Self-Guided Web Only Group	Behavioral: Self-guided Web Portal Resources Only; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving lifestyle behaviours and quality of life in children	Parents will complete a questionnaire assessing parent support for healthy family lifestyle environment and changes in their child's health-related quality of life. Children will complete questionnaires to assess their physical activity behaviours and dietary behaviours. These questionnaires will be completed at baseline, 10-week, 6-month and 12-month assessments.	From enrollment to 12 month follow-up
Child physical activity measurements	Changes in physical activity for the child will be measured using FitBit activity trackers. One week of daily step counts will be captured at baseline, 10-week, 6-month and 12-month assessments.	From enrollment to 12 month follow-up

Collaborators and Investigators

• Sponsor: University of Victoria
• Investigators: Principal Investigator: Sam Liu, University of Victoria

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: H20-00759; PJT - 169013 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will only be shared with co-investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No