Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Behavioral: Healthy Weight Clinic Behavioral: Healthy Weight and Your Child Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 407 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)
Actual Study Start Date : December 2016
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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.
 Behavioral: Healthy Weight and Your Child


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012126


Sponsors and Collaborators
Massachusetts General Hospital
Massachusetts Department of Health
Y-USA
Yale School of Medicine
Harvard School of Public Health
Investigators
Layout table for investigator information
Principal Investigator: Elsie Taveras, MD, MPH MassGeneral Hospital for Children
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Elsie Taveras, MD, Chief, Division of General Academic Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03012126    
Other Study ID Numbers: 937121
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight