Mobile Integrated Care for Childhood Obesity
Part of paid clinical trials in Milford, Delaware.
- Sponsor
- Nemours Children's Health System
- Study ID
- NCT05936385
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Healthy Lifestyle — BEHAVIORALHealthy 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.
- Standard of Care — BEHAVIORALWeight checks and lifestyle counseling with primary care provider every other month.
Study Details
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?
Key Dates
- Start date
- Jul 26, 2023
- Status verified
- Jul 2025
- Primary completion
- Jun 1, 2025
- Completion
- Jun 1, 2025
Study Design
- Enrollment
- 59 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Healthy LifestyleHealthy 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.
- Active Comparator: Standard of CareWeight checks and lifestyle counseling with primary care provider every other month.
Primary Outcome Measure
Change in Child Adiposity [ Time Frame: 6 months ]
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Nemours Children's Health, Milford | Milford | Delaware | 19963 | - |
| Nemours Children's Health, Millsboro | Millsboro | Delaware | 19966 | - |
| Nemours Children's Health, Seaford | Seaford | Delaware | 19973 | - |
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