Childhood Obesity Management Using Innovative Digital Technology

NCT ID: NCT06777888

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2025-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Family Healthy Living Program Intervention Group

Group Type: EXPERIMENTAL

Family Healthy Living Program weekly group sessions

Intervention Type: 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.

Self-Guided Web Only Group

Group Type: OTHER

Self-guided Web Portal Resources Only

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Family Healthy Living Intervention; Early Intervention Program; Generation Health Community

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Victoria

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Liu

Role: PRINCIPAL_INVESTIGATOR

University of Victoria

Locations

University of Victoria

Victoria, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 41085996 (View on PubMed)

Other Identifiers

PJT - 169013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H20-00759

Identifier Type: -

Identifier Source: org_study_id