Clinical & Community Approaches to Weight Management

Overweight and Obesity Clinical Trial

— CORD 2  

Official title:

Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012126
• Other study ID #: 937121
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: September 2019

Study information

• Verified date: February 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Healthy Weight Clinic

• Healthy Weight and Your Child

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Harvard School of Public Health, Massachusetts Department of Health, Y-USA, Yale School of Medicine

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Child BMI at 12 months		0-12 months
Primary	Change in Child BMI percent of the 95th percentile at 12 months		0-12 months
Secondary	Change in Screen Time at 12 months	Average hours per day of screen time as reported by parent	0-12 months
Secondary	Change in Sleep Duration at 12 months	Average hours per day of sleep as reported by parent	0-12 months
Secondary	Change in Physical Activity at 12 months	Average number of days (0-7) child is physically active for at least 60 minutes as reported by parent	0-12 months
Secondary	Change in Diet at 12 months	Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent	0-12 months