Mobile Integrated Care for Childhood Obesity

NCT05936385 | Completed Results

• 2 other identifiers: 416-ProjectP20GM144270
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 3

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?

Conditions

Obesity

Keywords

Disparities; Stakeholder engagement; Social determinants of health; Healthcare delivery

Outcome Measures

Primary Outcomes (2)

• 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

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

  6 months

Secondary Outcomes (2)

• 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 Arms (2)

Healthy Lifestyle

EXPERIMENTAL

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

Standard of Care

ACTIVE COMPARATOR

Weight checks and lifestyle counseling with primary care provider every other month.

Behavioral: Standard of Care

Interventions

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.

Healthy Lifestyle

Standard of Care BEHAVIORAL

Weight checks and lifestyle counseling with primary care provider every other month.

Standard of Care

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Health System: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (3)

Nemours Children's Health, Milford

Milford, Delaware, 19963, United States

Location

Nemours Children's Health, Millsboro

Millsboro, Delaware, 19966, United States

Location

Nemours Children's Health, Seaford

Seaford, Delaware, 19973, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Thao-Ly Phan, Associate Professor of Pediatrics
• Organization: Nemours Children's Health

tphan@nemours.org

302-331-7342

Study Officials

• Thao-Ly T Phan, MD, MPH

  Nemours Children's Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 7, 2023
• Study Start: July 26, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Locations

US (3)