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Clinical & Community Approaches to Weight Management (CORD 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03012126
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
Massachusetts Department of Health
Y-USA
Yale School of Medicine
Harvard School of Public Health
Information provided by (Responsible Party):
Elsie Taveras, MD, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE December 12, 2016
First Posted Date  ICMJE January 6, 2017
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE December 2016
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2020)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • Change in Child BMI z-score at 6 months [ Time Frame: 0-6 months ]
  • Change in Child BMI z-score at 12 months [ Time Frame: 0-12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical & Community Approaches to Weight Management
Official Title  ICMJE Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Overweight and Obesity
Intervention  ICMJE
  • Behavioral: Healthy Weight Clinic
  • Behavioral: Healthy Weight and Your Child
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Healthy Weight Clinic
  • 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.
    Intervention: Behavioral: Healthy Weight and Your Child
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2020)
407
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)
500
Actual Study Completion Date  ICMJE September 2019
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03012126
Other Study ID Numbers  ICMJE 937121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elsie Taveras, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • Massachusetts Department of Health
  • Y-USA
  • Yale School of Medicine
  • Harvard School of Public Health
Investigators  ICMJE
Principal Investigator: Elsie Taveras, MD, MPH MassGeneral Hospital for Children
PRS Account Massachusetts General Hospital
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP