Clinical trial NCT03012126: Clinical & Community Approaches to Weight Management
Official title: Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Department of Health
name: Y-USA
name: Yale University
name: Harvard School of Public Health (HSPH)
First posted: 2017-01-06
Enrollment: 407
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Child BMI at 12 months
timeFrame: 0-12 months
measure: Change in Child BMI percent of the 95th percentile at 12 months
timeFrame: 0-12 months
Secondary outcomes:
measure: Change in Screen Time at 12 months
timeFrame: 0-12 months
measure: Change in Sleep Duration at 12 months
timeFrame: 0-12 months
measure: Change in Physical Activity at 12 months
timeFrame: 0-12 months
measure: Change in Diet at 12 months
timeFrame: 0-12 months
Other outcomes:
Locations:
Study officials:
affiliation: MassGeneral Hospital for Children
name: Elsie Taveras, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. 2023 Dec;19(8):507-514. doi: 10.1089/chi.2022.0112. Epub 2022 Oct 28.
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.
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.
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.
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.