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Clinical & Community Approaches to Weight Management (CORD 2)

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy Weight Clinic
Healthy Weight and Your Child
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Clinically Based: Healthy Weight Clinic

    Community Based: Healthy Weight & Your Child

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in Child BMI at 12 months
    Change in Child BMI percent of the 95th percentile at 12 months

    Secondary Outcome Measures

    Change in Screen Time at 12 months
    Average hours per day of screen time as reported by parent
    Change in Sleep Duration at 12 months
    Average hours per day of sleep as reported by parent
    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
    Change in Diet at 12 months
    Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent

    Full Information

    First Posted
    December 12, 2016
    Last Updated
    February 3, 2021
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Massachusetts Department of Health, Y-USA, Yale School of Medicine, Harvard School of Public Health (HSPH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03012126
    Brief Title
    Clinical & Community Approaches to Weight Management
    Acronym
    CORD 2
    Official Title
    Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    September 2019 (Actual)
    Study Completion Date
    September 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    Massachusetts Department of Health, Y-USA, Yale School of Medicine, Harvard School of Public Health (HSPH)

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overweight and Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    407 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinically Based: Healthy Weight Clinic
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Community Based: Healthy Weight & Your Child
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Weight Clinic
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Weight and Your Child
    Primary Outcome Measure Information:
    Title
    Change in Child BMI at 12 months
    Time Frame
    0-12 months
    Title
    Change in Child BMI percent of the 95th percentile at 12 months
    Time Frame
    0-12 months
    Secondary Outcome Measure Information:
    Title
    Change in Screen Time at 12 months
    Description
    Average hours per day of screen time as reported by parent
    Time Frame
    0-12 months
    Title
    Change in Sleep Duration at 12 months
    Description
    Average hours per day of sleep as reported by parent
    Time Frame
    0-12 months
    Title
    Change in Physical Activity at 12 months
    Description
    Average number of days (0-7) child is physically active for at least 60 minutes as reported by parent
    Time Frame
    0-12 months
    Title
    Change in Diet at 12 months
    Description
    Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent
    Time Frame
    0-12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elsie Taveras, MD, MPH
    Organizational Affiliation
    MassGeneral Hospital for Children
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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.
    Citations:
    PubMed Identifier
    29330083
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    36315223
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    34862470
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    34619054
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    34470816
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    32663093
    Citation
    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.
    Results Reference
    derived

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