Mobile Integrated Care for Childhood Obesity

Sponsor

Nemours Children's Health System (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05936385

Collaborator

National Institute of General Medical Sciences (NIGMS) (NIH)

184

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Healthy Lifestyle Behavioral: Standard of Care	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

184 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

Mobile Integrated Care for Childhood Obesity

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Jun 30, 2026

Arms and Interventions

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.

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

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.

Outcome Measures

Primary Outcome Measures

Change in child adiposity [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 [6 months]
Percentage of study visits attended and lost to follow-up (attrition) from study as documented in the electronic health record.

Secondary Outcome Measures

Differences in change in child adiposity based on child sociodemographic characteristics [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.
Differences in visit adherence based on child sociodemographic characteristics [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)