Clinical & Community Approaches to Weight Management

NCT03012126 | Completed

• 1 other identifier: 937121
• Study Type: interventional
• Target: 407
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in Screen Time at 12 months

  0-12 months

• Change in Sleep Duration at 12 months

  0-12 months

• Change in Physical Activity at 12 months

  0-12 months

• Change in Diet at 12 months

  0-12 months

Study Arms (2)

Clinically Based: Healthy Weight Clinic

EXPERIMENTAL

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

Community Based: Healthy Weight & Your Child

EXPERIMENTAL

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

Interventions

Healthy Weight Clinic BEHAVIORAL

Clinically Based: Healthy Weight Clinic

Healthy Weight and Your Child BEHAVIORAL

Community Based: Healthy Weight & Your Child

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Department of Health: collaborator
• Y-USA: collaborator
• Yale University: collaborator
• Harvard School of Public Health (HSPH): collaborator

Related Publications (6)

• 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.

  PMID: 29330083 BACKGROUND

• 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.

  PMID: 36315223 DERIVED

• 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.

  PMID: 34862470 DERIVED

• 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.

  PMID: 34619054 DERIVED

• 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.

  PMID: 34470816 DERIVED

• 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.

  PMID: 32663093 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Elsie Taveras, MD, MPH

  MassGeneral Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of General Academic Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: January 6, 2017
• Study Start: December 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data can be requested by emailing the PI or Project Manager.
• Access Criteria: 1. An analysis plan is prepared and approved by the PI/Co-Is 2. IRB approval has been obtained, and 3. all necessary data sharing agreements have been executed.