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Active, Not Recruiting

NCT Number: NCT06777888

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Victoria

Victoria, British Columbia, V8P 5C2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Family Healthy Living Intervention, Early Intervention Program, Generation Health Community

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.

Primary outcomes

  1. Child BMI Z-scores

    Time frame: From enrollment to 12 month follow-up

    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.

Secondary outcomes

  1. Improving lifestyle behaviours and quality of life in children

    Time frame: From enrollment to 12 month follow-up

    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.

  2. Child physical activity measurements

    Time frame: From enrollment to 12 month follow-up

    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.

Sponsors and collaborators

Lead sponsor

University of Victoria

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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