Clinical & Community Approaches to Weight Management (CORD 2)
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|ClinicalTrials.gov Identifier: NCT03012126|
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : February 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity||Behavioral: Healthy Weight Clinic Behavioral: Healthy Weight and Your Child||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||407 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Children were randomized to either: 1) federally qualified health center-based Healthy Weight Clinic, or 2) YMCA community-based Healthy Weight and Your Child Program.
A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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 ]
- 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
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
|Principal Investigator:||Elsie Taveras, MD, MPH||MassGeneral Hospital for Children|