Online Program for Childhood Obesity

Overseen By Michelle Clayson

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Serious medical problems, others

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

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two online programs designed to help families with young children improve daily routines around mealtime, sleep, and screen time. One program includes guided online sessions led by a parent leader, while the other provides informational materials via email. The goal is to determine which method better supports healthy habits and self-regulation in children. Families with children aged 2 to 5 who qualify for public health insurance and can participate online or in person are well-suited for this study. As an unphased trial, this study offers families the opportunity to contribute to valuable research that could enhance daily routines and improve children's health.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What prior data suggests that these approaches to support healthy family routines are safe?

Research has shown that online programs for childhood obesity can be safe and effective. For instance, one study found that an internet-based program focused on parents helped improve healthy lifestyle habits in young children. Another study showed that structured online activities positively influenced parents' knowledge and actions regarding healthy living.

These findings suggest that online programs are generally well-received and safe. These studies reported no serious side effects or problems. Thus, participating in an online program like the one under study is likely safe for both parents and children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Online Program for childhood obesity because it offers a unique, convenient way for parents to help manage their children's weight. Unlike traditional in-person counseling or educational sessions, this program is entirely online, making it more accessible and flexible for busy families. It also emphasizes parental involvement, which can lead to more sustainable lifestyle changes at home. This approach could potentially make a significant impact by reaching a wider audience and encouraging long-term health improvements.

What evidence suggests that this trial's programs could be effective for childhood obesity?

Research has shown that online programs can help families develop healthy habits to combat childhood obesity. In this trial, one group of participants will engage in an online program designed for parents to guide preschool children in making better lifestyle choices. Studies have found that internet-delivered programs can improve health in overweight children. Specifically, one study showed that a virtual program was as effective as a mix of in-person and online sessions in enhancing children's lifestyle habits. These findings suggest that online programs can effectively support healthy family routines and address childhood obesity. ^{1 2 6 7 8}

Who Is on the Research Team?

Katherine Bauer, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for legal guardians of children aged 2-5 who are eligible for public health insurance. Participants must be able to engage in study activities in English and complete them at a designated location or from home, including online via Zoom. Children with serious medical issues affecting weight, sleep, activity, or eating cannot participate.

Inclusion Criteria

My child qualifies for public health insurance.

Parents must be able to complete the study activities in English

I am the legal guardian of a child aged 2-5.

Exclusion Criteria

My child does not have serious health issues affecting their daily habits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Families participate in either a parent leader-guided online program or receive informational materials via email to support healthy family routines

5 months

Follow-up

Participants are monitored for changes in child BMI, sleep duration, screentime, and dietary intake

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control Condition
• Online program

Trial Overview The study compares two programs aimed at promoting healthy family routines: one is an online program led by parent leaders focusing on self-regulation; the other provides asynchronous information about healthy habits. Families will be randomly placed into one of these groups to see which is more effective.

How Is the Trial Designed?

Group I: Online Program Experimental Treatment 1 Intervention

Parents will participate in an online program.

Group II: Control condition - Informational materials via email Active Control 1 Intervention

Parents will receive information via email.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Health Resources and Services Administration (HRSA)

Collaborator

Trials

88

Recruited

152,000+

Published Research Related to This Trial

The Time2bHealthy program is an innovative 11-week online intervention designed for parents of preschool-aged children, focusing on healthy lifestyle changes, and is being evaluated through a randomized controlled trial involving various health outcomes, including BMI.

This study is significant as it targets early childhood obesity prevention, filling a gap in existing literature, and if effective, could be widely implemented in primary health care services to promote healthier behaviors among families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time2bHealthy - An online childhood obesity prevention program for preschool-aged children: A randomised controlled trial protocol. Hammersley, ML., Jones, RA., Okely, AD.[2018]

In a 10-week school-based program involving 63 obese children aged 5 to 12, 95% of participants lost weight, achieving an average weight loss of 4.4 kg and a 15.4% decrease in their percentage overweight.

The program was significantly more effective than no intervention, as only 21% of a control group of obese children lost weight, highlighting the importance of comprehensive behavior modification and support in managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based behavior modification, nutrition education, and physical activity program for obese children. Brownell, KD., Kaye, FS.[2018]

A two-week weight-management camp followed by a 10-week community intervention significantly reduced BMI in overweight and obese Qatari children (n=300), demonstrating effective weight management strategies.

The combination of cognitive behavioral therapy and behavior change techniques in the community program helped maintain weight loss achieved during the camp, indicating its potential for long-term weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing a multicomponent lifestyle intervention for combatting childhood obesity. Vlaev, I., Taylor, MJ., Taylor, D., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6384541/

An Internet-Based Childhood Obesity Prevention Program ... This study aimed to assess the efficacy of a parent-focused, internet-based healthy lifestyle program for preschool-aged children.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000506

Evaluating the Long-Term Effectiveness of a Structured ... This study investigates the effectiveness and sustainability of a structured, multimodal pediatric obesity intervention delivered via telehealth ...

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

The effectiveness of a 10-week family-focused e-Health ... In this study, a family-focused web-based program effectively improved health-related outcome measures in children with overweight and obesity.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9635440/

Evaluating the Effectiveness of a Family-Based Virtual ... The study findings suggested that the virtual GH program was as effective as the blended program for improving child lifestyle behaviors and ...

5. liebertpub.com liebertpub.com/doi/10.1089/chi.2020.0236

The Effectiveness of a Blended In-Person and Online ... The purpose of this study was to evaluate the effectiveness of a 10-week blended family-based childhood obesity management program, relative to a wait-list ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10904600/

Time to act on childhood obesity: the use of technology - PMC The results indicated promising outcomes, suggesting that the online program had a positive impact on parents' knowledge and behaviors ...

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

Outcomes of a 24-month childhood obesity prevention ... The primary outcome was change in child body mass index (BMI) z-score at 24 months. Secondary outcomes included number of positive child and parent changes in ...

8. cdc.gov cdc.gov/pcd/issues/2020/20_0214.htm

Collecting Early Childhood Obesity Measurements ... Findings suggest that collecting data on child measurements through an existing home visiting program is 1) feasible (91% of estimated ...