Mobile Integrated Care for Childhood Obesity

Nemours Children's Health System

Status: Active, not recruiting

Conditions: Obesity

Treatments: Behavioral: Healthy Lifestyle; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05936385

P20GM144270 (U.S. NIH Grant/Contract)

416-Project

Details and patient eligibility

About

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?

Enrollment: 59 patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

59 participants in 2 patient groups

Healthy Lifestyle

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy Lifestyle

Standard of Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard of Care