N/A N=59 Randomized Single-blind Health Services Research

Mobile Integrated Care for Childhood Obesity

Obesity

Bottom Line

View on ClinicalTrials.gov: NCT05936385 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Change in Child Adiposity — -0.55; 0.64 Change in BMI percentile

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Healthy Lifestyle (Behavioral); Standard of Care (Behavioral)
Age: Pediatric, Adult, Older Adult · 4+ yrs
Sex: All
Sponsor: Nemours Children's Health System
Primary completion: Jun 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Child Adiposity	-0.55; 0.64	—
PRIMARY Visit Adherence	8; 8	—
SECONDARY Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics	-0.56; -0.09; 0.81; 1.67; -1.90; -0.04	—
SECONDARY Differences in Visit Adherence Based on Child Sociodemographic Characteristics	5; 4; 5; 7; 3; 1	—

Summary

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?

Eligibility Criteria

Caregiver and child dyads will be enrolled

Inclusion Criteria

Child 4-12 years of age
Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro
Child has a BMI ≥ 95% for age and sex
Child is from a clinic serving rural neighborhoods (RUCA ≥ 4)

Exclusion Criteria

Caregiver not child's legal guardian
Caregiver not proficient in English or Spanish
Caregiver does not have a device and reliable internet
Child has a genetic syndrome or endocrine disorder that predisposes to obesity
Child is on a medication that impacts weight
Child is already enrolled in a weight management program

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05936385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.