Mobile Integrated Care for Childhood Obesity

Study Overview
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Brief Summary
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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?

Official Title
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Mobile Integrated Care for Childhood Obesity

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Healthy Lifestyle
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Lifestyle<br>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<br>* 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.<br>|
| Active Comparator: Standard of Care<br>Weight checks and lifestyle counseling with primary care provider every other month. | Behavioral: Standard of Care<br>* Weight checks and lifestyle counseling with primary care provider every other month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Percentage of study visits attended and lost to follow-up (attrition) from study as documented in the electronic health record. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 
| Differences in visit adherence based on child sociodemographic characteristics | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disparities, Stakeholder engagement, Social determinants of health, Healthcare delivery