Mobile Integrated Care for Childhood Obesity
- Conditions
- Obesity
- Interventions
- Behavioral: Healthy LifestyleBehavioral: Standard of Care
- Registration Number
- NCT05936385
- Lead Sponsor
- Nemours Children's Health System
- 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?
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 59
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Lifestyle 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. Standard of Care Standard of Care Weight checks and lifestyle counseling with primary care provider every other month.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- 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