Mobile Integrated Care for Childhood Obesity

July 3, 2025 updated by: Thao-Ly Phan, Nemours Children's Health System

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Delaware
      • Milford, Delaware, United States, 19963
        • Nemours Children's Health, Milford
      • Millsboro, Delaware, United States, 19966
        • Nemours Children's Health, Millsboro
      • Seaford, Delaware, United States, 19973
        • Nemours Children's Health, Seaford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
Behavioral: Standard of Care
Weight checks and lifestyle counseling with primary care provider every other month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Child Adiposity
Time Frame: 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.
6 months
Visit Adherence
Time Frame: 6 months
Lost to follow-up (attrition) from study as documented in the electronic health record.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics
Time Frame: 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.
6 months
Differences in Visit Adherence Based on Child Sociodemographic Characteristics
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Health System

Collaborators

National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Thao-Ly T Phan, MD, MPH, Nemours Children's Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2023

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

June 20, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 3, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 416-Project
  • P20GM144270 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe