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OpenTrials
Completed

NCT Number: NCT03012126

Clinical & Community Approaches to Weight Management

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.

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Key information

Conditions

Overweight and Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Weight Clinic

Behavioral

Healthy Weight and Your Child

Behavioral

Primary outcomes

  1. Change in Child BMI at 12 months

    Time frame: 0-12 months

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

    Time frame: 0-12 months

Secondary outcomes

  1. Change in Screen Time at 12 months

    Time frame: 0-12 months

    Average hours per day of screen time as reported by parent

  2. Change in Sleep Duration at 12 months

    Time frame: 0-12 months

    Average hours per day of sleep as reported by parent

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Harvard School of Public Health (HSPH)
  • Massachusetts Department of Health
  • Y-USA
  • Yale University

Registry information

Official study title

Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)

Acronym: CORD 2

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 6, 2017
Registry last updated
Feb 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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