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

Sponsor:

Collaborators:

Massachusetts Department of Health

Y-USA

Yale School of Medicine

Harvard School of Public Health (HSPH)

Information provided by (Responsible Party):

Elsie Taveras, MD, Massachusetts General Hospital

Study Description

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

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	407 participants
Allocation:	Randomized
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)
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 Genetics related topics: Cone-rod dystrophy

MedlinePlus related topics: Body Weight

Genetic and Rare Diseases Information Center resources: Cone-rod Dystrophy Cone-rod Dystrophy 2

U.S. FDA Resources

Arms and Interventions

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

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

Primary Outcome Measures :

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 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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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

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 (HSPH)

Investigators

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Principal Investigator:	Elsie Taveras, MD, MPH	MassGeneral Hospital for Children

More Information

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.

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

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). pii: 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.

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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:	February 8, 2021
Last Verified:	February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
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.
Supporting Materials:	Study Protocol
Time Frame:	Data can be requested by emailing the PI or Project Manager.
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.

Additional relevant MeSH terms:

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Obesity Overweight Overnutrition Nutrition Disorders Body Weight

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