Clinical trial NCT06777888: Childhood Obesity Management Using Innovative Digital Technology
Official title: Childhood Obesity Management Using Innovative Digital Technology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity Prevention
Child Behaviour
Health Behaviour Change
Obesity and Overweight
Physical Activity
Lead sponsor: University of Victoria
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 270
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Child BMI Z-scores
timeFrame: From enrollment to 12 month follow-up
Secondary outcomes:
measure: Improving lifestyle behaviours and quality of life in children
timeFrame: From enrollment to 12 month follow-up
measure: Child physical activity measurements
timeFrame: From enrollment to 12 month follow-up
Other outcomes:
Locations:
city: Victoria
country: Canada
facility: University of Victoria
state: British Columbia
Study officials:
affiliation: University of Victoria
name: Sam Liu
role: PRINCIPAL_INVESTIGATOR
References: