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Clinical Trials/NCT05936385
NCT05936385
Completed
Not Applicable

Mobile Integrated Care for Childhood Obesity

Nemours Children's Health System3 sites in 1 country59 target enrollmentJuly 26, 2023
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Nemours Children's Health System
Enrollment
59
Locations
3
Primary Endpoint
Change in Child Adiposity
Status
Completed
Last Updated
9 months ago

Overview

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?
Registry
clinicaltrials.gov
Start Date
July 26, 2023
End Date
June 1, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thao-Ly Phan

Associate Professor of Pediatrics

Nemours Children's Health System

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Visit Adherence

Time Frame: 6 months

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

Secondary Outcomes

  • Differences in Change in Child Adiposity Based on Child Sociodemographic Characteristics(6 months)
  • Differences in Visit Adherence Based on Child Sociodemographic Characteristics(6 months)

Study Sites (3)

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