Mobile Integrated Care for Childhood Obesity

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT05936385
• Lead Sponsor: Nemours Children's Health System

Brief 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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-07
• Study Start: 2023-07-26
• Results First Submitted: 2025-05-30
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Results First Posted: 2025-07-24
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Child Adiposity	6 months	Change in BMI percentile (above the 95th percentile) for age and sex. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms.
Visit Adherence	6 months	Lost to follow-up (attrition) from study as documented in the electronic health record.

Secondary Outcome Measures

Name	Time	Method
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics	6 months	Differences in change in BMI percentile (above the 95th percentile) for age and sex between subgroups based on race, ethnicity, and insurance status. Height and weight measurements will be used to calculate BMI percentile above the 95th percentile based on CDC algorithms. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.
Differences in Visit Adherence Based on Child Sociodemographic Characteristics	6 months	Differences in lost to follow-up (attrition) from study as documented in the electronic health record between subgroups based on race, ethnicity, and insurance status. Child race, ethnicity, and insurance status will be collected from parents at the time of enrollment.

Trial Locations

Locations (3)

Nemours Children's Health, Milford; 🇺🇸 Milford, Delaware, United States

Nemours Children's Health, Millsboro; 🇺🇸 Millsboro, Delaware, United States

Nemours Children's Health, Seaford; 🇺🇸 Seaford, Delaware, United States