Mobile Integrated Care for Childhood Obesity

Nemours Children's Health System59 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Obesity

Interventions

Eligibility

Sex: ALLMin age: 4 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Nemours Children's Health, Milford

Milford, Delaware, United States

Nemours Children's Health, Millsboro

Millsboro, Delaware, United States

Nemours Children's Health, Seaford

Seaford, Delaware, United States

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Visit Adherence

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

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

Differences in Visit Adherence Based on Child Sociodemographic Characteristics

Differences in 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.

Time frame: 6 months