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?

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Healthy Lifestyle; Behavioral: Standard of Care

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thao-Ly T Phan, MD, MPH; Phone Number: 302-331-7342; Email: thaoly.phan@nemours.org

Study Locations

• United States
  • Delaware
    • Milford, Delaware, United States, 19963
      • Recruiting
      • Nemours Children's Health, Milford
      • Contact: Suzanne Bagas, MD
    • Millsboro, Delaware, United States, 19966
      • Recruiting
      • Nemours Children's Health, Millsboro
      • Contact: Harry Lehman, MD
    • Seaford, Delaware, United States, 19973
      • Recruiting
      • Nemours Children's Health, Seaford
      • Contact: Thiele Anthony, MD

Participation Criteria

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 rural neighborhood (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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	Percentage of study visits attended and 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	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	Differences in percentage of study visits attended and 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

• 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

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

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 (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Disparities; Social determinants of health; Healthcare delivery; Stakeholder engagement
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• 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