Clinical & Community Approaches to Weight Management

Not Applicable

Completed

• Conditions: Overweight and Obesity

• Registration Number: NCT03012126
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

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