Clinical & Community Approaches to Weight Management

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.

Full Title of Study: “Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2019

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.

Interventions

  • Behavioral: Healthy Weight Clinic
  • Behavioral: Healthy Weight and Your Child

Arms, Groups and Cohorts

  • Experimental: Clinically Based: Healthy Weight Clinic
    • 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.
  • Experimental: Community Based: Healthy Weight & Your Child
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change in Screen Time at 12 months
    • Time Frame: 0-12 months
    • Average hours per day of screen time as reported by parent
  • Change in Sleep Duration at 12 months
    • Time Frame: 0-12 months
    • Average hours per day of sleep as reported by parent
  • Change in Physical Activity at 12 months
    • Time Frame: 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
    • Time Frame: 0-12 months
    • Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Collaborator
    • Massachusetts Department of Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elsie Taveras, MD, Chief, Division of General Academic Pediatrics – Massachusetts General Hospital
  • Overall Official(s)
    • Elsie Taveras, MD, MPH, Principal Investigator, MassGeneral Hospital for Children

References

Fiechtner L, Perkins M, Biggs V, Langhans N, Sharifi M, O'Connor G, Price S, Locascio J, Kuhlthau K, Kwass JA, Nelson C, Land T, Longjohn M, Lawson V, Hohman K, Taveras EM. Rationale and design of the Clinic and Community Approaches to Healthy Weight Randomized Trial. Contemp Clin Trials. 2018 Apr;67:16-22. doi: 10.1016/j.cct.2018.01.002. Epub 2018 Jan 10.

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