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 — BEHAVIORAL
    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.
  • Standard of Care — BEHAVIORAL
    Weight 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 Lifestyle
    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.
  • Active Comparator: Standard of Care
    Weight checks and lifestyle counseling with primary care provider every other month.

Primary Outcome Measure

Change in Child Adiposity [ Time Frame: 6 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Nemours Children's Health, MilfordMilfordDelaware19963-
Nemours Children's Health, MillsboroMillsboroDelaware19966-
Nemours Children's Health, SeafordSeafordDelaware19973-

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