Mobile Integrated Care for Childhood Obesity

No longer recruiting at 2 trial locations

Overseen By Thao-Ly T Phan, MD, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nemours Children's Health System

Must not be taking: Weight-impacting medications

Disqualifiers: Genetic syndrome, Endocrine disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist children with unhealthy weight by comparing two different approaches. One group will receive healthy lifestyle advice from their child's doctor, while the other will participate in a program featuring expert counseling, a supportive app, and community activities. The study aims to determine if the program improves children's weight, maintains family engagement, and is effective for certain communities. Families with children aged 4-12, who are patients at specific Nemours clinics and have a BMI in the top 5% for their age and sex, may be eligible to participate. As an unphased trial, this study offers families the chance to explore innovative approaches to healthier living.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications, but children on medications that impact weight are excluded from participating.

What prior data suggests that this method is safe for children with an unhealthy weight?

Research has shown that using a mobile app to encourage healthy habits is generally safe for children. One study on a mobile lifestyle program found that kids handled it well, with no major side effects reported. This indicates that the app, which promotes a healthy lifestyle, is safe for children to use.

Additionally, using digital tools like apps in managing obesity has yielded good results. Kids in these programs often experience improvements without major safety issues, including lower body mass index (BMI, a measure of body fat) and increased activity levels.

While these studies examined different groups, they provide strong evidence that using a mobile app and community support for lifestyle changes is safe for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Lifestyle approach for childhood obesity because it offers a comprehensive, tech-savvy strategy that's different from the standard weight checks and counseling typically received in primary care. This approach includes monthly goal-setting with a team of experts, a mobile app with resources, and community support, which together create a more engaging and personalized experience. By integrating technology and community resources, this method not only aims to improve health outcomes but also empowers children and their families to take charge of their wellness journey.

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

Research shows that mobile apps can help manage childhood obesity by promoting healthy lifestyles. Studies have found that children using these apps often eat fewer sugary and salty snacks and spend less time on screens. One approach even led to a noticeable drop in BMI z-scores, a measure of body weight compared to height, and increased physical activity. In this trial, participants in the "Healthy Lifestyle" arm will receive monthly healthy lifestyle counseling and goal setting with a team of experts, along with a mobile app featuring healthy lifestyle resources and a goal tracking tool. This arm also includes access to social services and lifestyle programs in the community, with community health worker outreach every month. Using digital health tools in managing childhood obesity has been linked to better weight outcomes. These findings suggest that a program combining digital tools and community support could help children lead healthier lives. ^{3 6 7 8 9}

Who Is on the Research Team?

Thao-Ly T Phan, MD, MPH

Principal Investigator

Nemours Children's Health

Are You a Good Fit for This Trial?

This trial is for children aged 4-12 with obesity, who are patients at specific Nemours Children's Health clinics in rural areas. They must have a BMI ≥ 95% for their age and sex. Kids can't join if they have certain genetic or endocrine disorders, take weight-affecting meds, or if the caregiver isn't their legal guardian or doesn't speak English/Spanish.

Inclusion Criteria

My child is between 4 and 12 years old.

Child is from a rural neighborhood (RUCA ≥ 4)

Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro

Exclusion Criteria

My caregiver does not speak English or Spanish well.

Caregiver does not have a device and reliable internet

Caregiver not child's legal guardian

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either standard care or the Healthy Lifestyle program for 6 months

6 months

Monthly visits with lifestyle specialists or primary care providers

Follow-up

Participants are monitored for changes in BMI and visit adherence

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Lifestyle
• Standard of Care

Trial Overview The study compares two approaches to help kids with unhealthy weight: standard care versus a Healthy Lifestyle program that includes specialist check-ins, a mobile app for lifestyle support, and community activities. The aim is to see which group shows better weight outcomes and retention rates.

How Is the Trial Designed?

Group I: Healthy Lifestyle Experimental Treatment 1 Intervention

Healthy lifestyle counseling and goal setting every month with a team of experts, mobile app with healthy lifestyle resources and goal tracking tool, access to social services and lifestyle programs in the community, and community health worker outreach every month.

Group II: Standard of Care Active Control 1 Intervention

Weight checks and lifestyle counseling with primary care provider every other month.

Who Is Running the Clinical Trial?

Nemours Children's Health System

Lead Sponsor

Trials

11

Recruited

17,400+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Published Research Related to This Trial

The study involved 20 children and adolescents with obesity, who were randomized to either an mHealth intervention group using the Mandolean app or a control group receiving usual care, but faced a high attrition rate of 63% in the intervention group compared to 25% in the control group.

Low engagement with the Mandolean app and perceived task burden were significant barriers to adherence, suggesting that while self-monitoring tools like the myBigO app and smartwatches were acceptable, further improvements in the usability and acceptability of the Mandolean intervention are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. Browne, S., Kechadi, MT., O'Donnell, S., et al.[2021]

The US medical system currently struggles to effectively address childhood obesity, with primary care practices often not aligning with evidence-based recommendations for prevention and treatment.

Collaboration between childhood obesity specialists and primary care providers has shown promise in improving the quality of care for obesity prevention and treatment, highlighting the importance of systematic approaches to tackle this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building capacity for childhood obesity prevention and treatment in the medical community: call to action. Haemer, M., Cluett, S., Hassink, SG., et al.[2022]

The Healthy Weight Clinic model enhances child obesity care by integrating specialized visits from a trained team, including a pediatric provider, nutritionist, and case manager, directly within community health centers.

This approach not only increases access to specialized care but also emphasizes health behavior change and utilizes health information technology to improve the quality of care for managing obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialized care of overweight children in community health centers. Anand, SG., Adams, WG., Zuckerman, BS.[2010]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36810069/

Effectiveness of a Smartphone App (MINISTOP 2.0) ... Conclusion: Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9002598/

Effectiveness of Mobile Apps in Promoting Healthy ... This paper aims to conduct a systematic review examining the effectiveness of mobile apps aimed at preventing childhood obesity by promoting health behavior ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2667368125000336

Integrating digital health into pediatric obesity management Participants in the intervention group showed a significant reduction in BMI z-score and percentage overweight, along with increased MVPA (+7.4 ​min/day) and ...

4. formative.jmir.org formative.jmir.org/2025/1/e60495

mHealth App to Promote Healthy Lifestyles for Diverse ... Mobile Integrated Care for Childhood Obesity (MICCO) care model, developed by a research team for families of young children with obesity. As an ...

5. ijbnpa.biomedcentral.com ijbnpa.biomedcentral.com/articles/10.1186/s12966-023-01405-5

Effectiveness of a Smartphone App (MINISTOP 2.0) ... Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) and their ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8512185/

Use of a Mobile Lifestyle Intervention App as an Early ... This study aims to assess the effectiveness of and adolescent engagement with a mobile app–based lifestyle intervention program as an early intervention

7. trialx.com trialx.com/clinical-trials/listings/276667/mobile-integrated-care-for-childhood-obesity/

Mobile Integrated Care for Childhood Obesity Overview. The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12274300/

Integrating digital health into pediatric obesity management Participants in the intervention group showed a significant reduction in BMI z-score and percentage overweight, along with increased MVPA (+7.4 ...

9. cureus.com cureus.com/articles/419547-effectiveness-of-telehealth-and-wearable-device-based-interventions-for-managing-childhood-and-adolescent-obesity-a-systematic-review-and-meta-analysis.pdf?email=

Effectiveness of Telehealth and Wearable Device- Based ... The prevalence of obesity increased to 6.9% in girls and 9.3% in boys, resulting in a total of 160 million children (five to 19 years) living ...