Clinical & Community Approaches to Weight Management

Massachusetts General Hospital407 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

407

Conditions

Overweight and Obesity

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Child BMI at 12 months

Time frame: 0-12 months

Change in Child BMI percent of the 95th percentile at 12 months

Time frame: 0-12 months

Secondary Outcomes

Change in Screen Time at 12 months

Average hours per day of screen time as reported by parent

Time frame: 0-12 months

Change in Sleep Duration at 12 months

Average hours per day of sleep as reported by parent

Time frame: 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

Time frame: 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

Time frame: 0-12 months

Clinical & Community Approaches to Weight Management

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes