Mobile Integrated Care for Childhood Obesity

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

59 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight. Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months. The other group will be in our Healthy Lifestyle program for 6 months. This will include: * Check-ins with lifestyle specialists and community health workers, * A mobile app to help support a healthy lifestyle, and * Access to community programs and activities. The main questions the study aims to answer are: * Do children in the Healthy Lifestyle program have better weight outcomes? * Do more families in the Healthy Lifestyle program stay in the study? * Does the Healthy Lifestyle program work better for families from certain communities?

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 data supports the effectiveness of the treatment Healthy Lifestyle, Standard of Care, Standard Treatment, Conventional Care, Usual Care for childhood obesity?

Research shows that using mobile health apps to support family-based interventions can help improve eating and physical activity behaviors in children, which are key components in treating childhood obesity. ^{1 2 3 4 5}

Is the Mobile Integrated Care for Childhood Obesity treatment safe for children?

The FitKids Mobile Lifestyle Modification Program, which is similar to Mobile Integrated Care, was used with 86 children and showed positive feedback from parents about increased knowledge and motivation for a healthy lifestyle. No safety concerns were reported in the study. ^{1 4 6 7 8}

How is the Mobile Integrated Care for Childhood Obesity treatment different from other treatments?

This treatment is unique because it combines mobile health technology with integrated care, focusing on both eating and physical activity behaviors, and involves a multidisciplinary team to manage childhood obesity. It emphasizes local specialization and uses health information technology to enhance care quality, which is different from standard treatments that may not integrate these components. ^{1 3 9 10 11}

Research Team

Thao-Ly T Phan, MD, MPH

Principal Investigator

Nemours Children's Health

Eligibility Criteria

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

Caregiver does not have a device and reliable internet

My caregiver does not speak English or Spanish well.

Caregiver not child's legal guardian

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The development of the Dutch "National model integrated care for childhood overweight and obesity". [2023]

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

Evaluating 12 Years of Implementing a Multidisciplinary Specialist Child and Adolescent Obesity Treatment Service: Patient-Level Outcomes. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. [2021]

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

Tracking implementation within a community-led whole of system approach to address childhood overweight and obesity in south west Sydney, Australia. [2021]

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

Building capacity for childhood obesity prevention and treatment in the medical community: call to action. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Reaching Uninsured Overweight and Obese Children Through the FitKids Mobile Lifestyle Modification Program: Lessons Learned. [2020]

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

Comparison of parent-only vs family-based interventions for overweight children in underserved rural settings: outcomes from project STORY. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Family-based pediatric weight management interventions in US primary care settings targeting children ages 6-12 years old: A systematic review guided by the RE-AIM framework. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Health care providers' perceived barriers to and need for the implementation of a national integrated health care standard on childhood obesity in the Netherlands - a mixed methods approach. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Conducting a psychosocial and lifestyle assessment as part of an integrated care approach for childhood obesity: experiences, needs and wishes of Dutch healthcare professionals. [2023]

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

Specialized care of overweight children in community health centers. [2010]