Clinical & Community Approaches to Weight Management

Study Overview
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Brief Summary
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This project seeks to build on innovative strategies to optimize the care of low-income children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement a new clinical-community intervention, theoretically grounded in the Integrated Clinical and Community Systems of Care Model, to address obesity through optimized screening and management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy Weight and Your Child weight management program (originally known as MEND). The study will examine outcomes for children that matter most to a broad group of stakeholders including parents, clinicians, and public health practitioners as well as inform the care of >7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.

Detailed Description
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This is a 2-arm RCT. Enrolled patients are randomized to a pediatric weight management intervention (PWMI): 1)a Healthy Weight Clinic based at a federally-qualified health center (FQHC), or 2) a modified Healthy Weight and Your Child intervention delivered in YMCAs. A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.

Official Title
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Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Healthy Weight Clinic
* Behavioral: Healthy Weight and Your Child


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child is age 6.0 through 12.9 years at referral child's BMI meets or exceeds the 85th percentile for age and sex parent can read and respond to interviews and questionnaires in English and Spanish Exclusion Criteria: children who do not have at least one parent who is able to follow study procedures for 1 year families who plan to leave their primary care health center within the study time frame families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties children who were taking medications that substantially interfere with growth children who have a sibling enrolled in the study.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children were randomized to either: 1) federally qualified health center-based Healthy Weight Clinic, or 2) YMCA community-based Healthy Weight and Your Child Program. A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinically Based: Healthy Weight Clinic<br>All families referred to the Healthy Weight Clinic intervention arm will be scheduled for a 30-45 minute orientation clinic visit to orient the child and family to the program. During this visit, the family will meet with the community health worker who will provide a schedule of clinic visits and dietitian contacts. The community health worker will assess the child's social and environmental context to allow treatment tailoring. For the first 6 months, each family will be asked to attend two clinic visits per month and complete weekly 20-30 minute contacts with the dietitian via telephone. The program aims to deliver approximately 30 contact hours in the 6-month period. This will be followed by monthly visits to the Healthy Weight Clinic and monthly calls with their dietitian. | Behavioral: Healthy Weight Clinic<br> <br> |
| Experimental: Community Based: Healthy Weight & Your Child<br>All families referred to the Healthy Weight and Your Child intervention arm will be scheduled for a 60-minute family information session to orient the child and family to the program. During this visit, the family will receive information about the program and logistics such as program schedule and format and attendance. The program is delivered over 12 months, which includes 16 weekly sessions, followed by 4 sessions delivered every other week and concluding with 5 monthly sessions. Most sessions are 2 hours in length and include a group of about 8-15 children and their caregivers. The first hour is delivered in a classroom setting and the second hour in an additional area conducive for physical activity. | Behavioral: Healthy Weight and Your Child<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child BMI at 12 months |  | 0-12 months | 
| Change in Child BMI percent of the 95th percentile at 12 months |  | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Screen Time at 12 months | Average hours per day of screen time as reported by parent | 0-12 months | 
| Change in Sleep Duration at 12 months | Average hours per day of sleep as reported by parent | 0-12 months | 
| Change in Physical Activity at 12 months | Average number of days (0-7) child is physically active for at least 60 minutes as reported by parent | 0-12 months | 
| Change in Diet at 12 months | Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent | 0-12 months |