Digital Technology for Childhood Obesity

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Victoria

Disqualifiers: Below 85th percentile BMI, Non-English speakers, Physical activity limitations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the impact of a 10-week Family Healthy Living Program on families with children at risk of being above a healthy weight. The program includes nine weekly online group sessions with a facilitation team, while a comparison group will access only self-guided online resources. Researchers will track changes in healthy living habits, child growth patterns, and physical activity over 12 months. Families with children aged 8-12 who are at or above the 85th percentile for Body Mass Index (BMI) may be a good fit for this trial. As an unphased trial, this study offers families the chance to contribute to valuable research that could enhance healthy living programs for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems focused on healthy living habits rather than medication use.

What prior data suggests that this program is safe for children?

Research shows that the Family Healthy Living Program (FHLP) is safe and well-received. Studies on similar family lifestyle programs have not identified any major safety issues. For instance, a large study with thousands of participants demonstrated that these programs helped reduce overweight and obesity without causing harm. These programs typically include activities like exercise and nutrition advice, which are safe for both children and adults. Based on this, the FHLP's combination of group sessions and online resources appears safe for participating families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Technology for Childhood Obesity trial because it explores innovative approaches to tackling obesity in kids. The Family Healthy Living Program offers weekly group sessions that foster a supportive environment, potentially enhancing motivation and adherence compared to traditional treatments like medication or diet plans alone. Meanwhile, the Self-guided Web Portal empowers families to access resources at their convenience, promoting flexibility and self-management. These methods aim to engage children and their families in proactive lifestyle changes, offering a personalized and potentially more sustainable solution to childhood obesity.

What evidence suggests that this program is effective for childhood obesity?

Research has shown that the Family Healthy Living Program (FHLP), which participants in this trial may receive, can help children achieve healthier weights. In several studies, children in the FHLP experienced a noticeable drop in their BMI z-scores, a measure comparing a child's weight to peers of the same age and sex. These children also showed improvements in overall body weight and body fat. This suggests that the FHLP's combination of group meetings and online tools effectively encourages healthier habits in families with children who might be above a healthy weight. Another group in this trial will use self-guided web portal resources only, which will also be evaluated for effectiveness in promoting healthy weight management. ^{6 7 8 9 10}

Who Is on the Research Team?

Sam Liu

Principal Investigator

University of Victoria

Are You a Good Fit for This Trial?

This trial is for families with children aged 8-12 who are above a healthy weight and want to improve their lifestyle. Families must be willing to participate in online sessions or use web resources, complete surveys, and track child growth over a year.

Inclusion Criteria

My child's BMI is in the top 15% for their age and sex.

I am between 8-12 years old and my caregiver agrees to participate.

Exclusion Criteria

I cannot speak, read, or write in English.

My child cannot be physically active due to health issues.

My child's BMI is below the 85th percentile.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 10-week Family Healthy Living Program (FHLP) with 9 weekly 2-hour online group sessions and additional web-based resources

10 weeks

9 online group sessions

Follow-up

Participants are monitored for long-term impact with surveys and measurements at 6-month and 12-month post-program

12 months

4 assessments (baseline, post-program, 6-month, 12-month)

What Are the Treatments Tested in This Trial?

Interventions

• Family Healthy Living Program weekly group sessions
• Self-guided Web Portal Resources Only

Trial Overview The study tests the Family Healthy Living Program (FHLP), which includes weekly online group sessions on healthy living versus just using self-guided web resources. The impact of FHLP will be measured through surveys, child measurements, and FitBit step counts over 12 months.

How Is the Trial Designed?

Group I: Self-Guided Web Only Group Experimental Treatment 1 Intervention

Group II: Family Healthy Living Program Intervention Group Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Victoria

Lead Sponsor

Trials

59

Recruited

12,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12569496/

Evaluating the Effectiveness of a Family-Based Lifestyle ... On the basis of the study objectives, it is hypothesized that children in the FHLP intervention group will show greater reductions in BMI z ...

2. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-21120-5

The effectiveness of a 10-week family-focused e-Health ... A significant decrease in children's BMI z-scores was observed in the intervention compared to the control group over 10 weeks (mean difference ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38569168/

Outcomes of an Adapted Family Healthy Weight Program ... Participants had statistically significant improvements at 12 weeks in BMI z-score, %BMIp95, body mass, body fat, fat mass, fat-free mass, and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S221133552200393X

Outcomes of a 24-month childhood obesity prevention ... There was no significant change in parent outcomes. The Healthy Kids & Families intervention shows promise for obesity prevention among children in ...

5. liebertpub.com liebertpub.com/doi/10.1089/chi.2023.0142

Outcomes of an Adapted Family Healthy Weight Program ... Results: Nine cohorts of families between 2009 and 2016 completed the program with 82.1% retention at 12 weeks and 53.6% at 6 months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5738974/

Effectiveness of the Healthy Lifestyles Programme (HeLP) to ... We aimed to establish whether a school-based intervention for children aged 9–10 years would prevent excessive weight gain after 24 months.

7. cdc.gov cdc.gov/family-healthy-weight/php/recognized-programs/index.html

CDC-Recognized Family Healthy Weight Programs The 12-week program includes two 45-minute exercise sessions and one 40-minute nutrition or behavior modification session weekly. This program ...

8. researchprotocols.org researchprotocols.org/2025/1/e76837

Evaluating the Effectiveness of a Family-Based Lifestyle ... The FHLP aims to support children who are off the healthy weight trajectory by managing overweight and preventing progression to obesity through ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2793019

Maintenance Outcomes of the Children's Healthy Living ... The CHL randomized clinical trial of 9840 participants found that the prevalence of overweight and obesity decreased significantly by 12.60% 6 years after ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424001459

A randomized controlled trial examining general parenting ... This clinical trial tests the effect of parenting training on childhood obesity. Results will inform the development of more effective treatments.