Clinical & Community Approaches to Weight Management (CORD 2)

Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)

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.

Study Overview

• Status: Completed
• Conditions: Overweight and Obesity
• Intervention / Treatment: Behavioral: Healthy Weight Clinic; Behavioral: Healthy Weight and Your Child

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 407
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Child BMI at 12 months	0-12 months
Change in Child BMI percent of the 95th percentile at 12 months	0-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Screen Time at 12 months	Average hours per day of screen time as reported by parent	0-12 months
Change in Sleep Duration at 12 months	Average hours per day of sleep as reported by parent	0-12 months
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Harvard School of Public Health (HSPH); Massachusetts Department of Health; Y-USA; Yale School of Medicine
• Investigators: Principal Investigator: Elsie Taveras, MD, MPH, MassGeneral Hospital for Children

Publications and helpful links

General Publications

• 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.
• Fay C, Castro I, Sierra Velez D, Ruggiero CF, O'Connor G, Perkins M, Luo M, Sharifi M, Neri Mini F, Taveras EM, Kuhlthau K, Fiechtner L. Keys to Achieving Clinically Important Weight Loss: Perceptions of Responders and Nonresponders in the Clinic and Community Approaches to Healthy Weight Trial. Child Obes. 2022 Oct 28. doi: 10.1089/chi.2022.0112. Online ahead of print.
• Harshman SG, Castro I, Perkins M, Luo M, Barrett Mueller K, Cena H, Portale S, Raspini B, Taveras E, Fiechtner L. Pediatric weight management interventions improve prevalence of overeating behaviors. Int J Obes (Lond). 2022 Mar;46(3):630-636. doi: 10.1038/s41366-021-00989-x. Epub 2021 Dec 3.
• Sierra Velez D, Simione M, Castro I, Perkins M, Luo M, Taveras EM, Fiechtner L. Effects of a Pediatric Weight Management Intervention on Parental Stress. Child Obes. 2022 Apr;18(3):160-167. doi: 10.1089/chi.2021.0146. Epub 2021 Oct 7.
• Fiechtner L, Perkins M, Biggs V, Langhans N, Sharifi M, Price S, Luo M, Locascio JJ, Hohman KH, Hodge H, Gortmaker S, Torres S, Taveras EM. Comparative Effectiveness of Clinical and Community-Based Approaches to Healthy Weight. Pediatrics. 2021 Oct;148(4):e2021050405. doi: 10.1542/peds.2021-050405. Epub 2021 Sep 1.
• Atkins M, Castro I, Sharifi M, Perkins M, O'Connor G, Sandel M, Taveras EM, Fiechtner L. Unmet Social Needs and Adherence to Pediatric Weight Management Interventions: Massachusetts, 2017-2019. Am J Public Health. 2020 Jul;110(S2):S251-S257. doi: 10.2105/AJPH.2020.305772.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: 937121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual-level data may be shared upon request, under the conditions that an analysis plan is prepared and approved by the PI/Co-Is, IRB approval has been obtained, and all necessary data sharing agreements have been executed.
• IPD Sharing Time Frame: Data can be requested by emailing the PI or Project Manager.
• IPD Sharing Access Criteria: An analysis plan is prepared and approved by the PI/Co-Is; IRB approval has been obtained, and; all necessary data sharing agreements have been executed.
• IPD Sharing Supporting Information Type: Study Protocol