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

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the online program treatment for childhood obesity?

Research shows that electronic health programs can improve obesity-related behaviors in children. Additionally, a telehealth-based treatment program for children with obesity resulted in a high proportion of children reducing their body mass index, similar to traditional on-site care. ^{1 2 3 4 5}

Is the online program for childhood obesity safe for children?

The research articles provided do not contain specific safety data for the online program for childhood obesity or similar interventions. ^{5 6 7 8 9}

How is the Online Program for Childhood Obesity different from other treatments for childhood obesity?

The Online Program for Childhood Obesity is unique because it leverages internet-based interventions to provide accessible and scalable support for children and their families, focusing on early childhood stages and involving parents in the process. This approach contrasts with traditional in-person consultations, offering a flexible and potentially more engaging way to address obesity in children. ^{2 10 11 12 13}

What is the purpose of this trial?

This study will evaluate the effects of two different approaches to support healthy family mealtime, sleep, and screentime routines: A parent leader-guided online program that promotes parent and child self-regulation as a means to improve healthy family routines versus an asynchronous program that provides parents information about healthy family routines. Families will be randomly assigned to either of these programs and changes in parent and child outcomes will be evaluated.

Research Team

Katherine Bauer, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

My child qualifies for public health insurance.

Parents must be able to complete the study activities in English

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

An Internet-Based Childhood Obesity Prevention Program (Time2bHealthy) for Parents of Preschool-Aged Children: Randomized Controlled Trial. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of a Telehealth-Based Intensive Treatment Program with a Rewarding App vs. On-Site Care for Youth with Obesity: A Historical Cohort Study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Modest treatment effects and high program attrition: The impact of interdisciplinary, individualized care for managing paediatric obesity. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Testing a multicomponent lifestyle intervention for combatting childhood obesity. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Adolescents with severe obesity: outcomes of participation in an intensive obesity management programme. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Process evaluation results of a cluster randomised controlled childhood obesity prevention trial: the WAVES study. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of weight regain on cardiometabolic health in children with obesity: A systematic review of clinical studies. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Designing and implementing an effective pediatric weight management program. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

The effects of nutritional-physical activity school-based intervention on fatness and fitness in preschool children. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Time2bHealthy - An online childhood obesity prevention program for preschool-aged children: A randomised controlled trial protocol. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Development of an internet-based obesity prevention program for children. [2021]

13. Czech Republic pubmed.ncbi.nlm.nih.gov

[With children against obesity]. [2018]