Skip to main content
OpenTrials
Completed

NCT Number: NCT05936385

Mobile Integrated Care for Childhood Obesity

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?

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Health, Milford, Milford, Delaware, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Visit Adherence

    Time frame: 6 months

    Lost to follow-up (attrition) from study as documented in the electronic health record.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Nemours Children's Health System

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.