Pediatric Healthy Weight Clinic (CORD)

Healthy Weight Clinic: Packaging and Spreading Proven Pediatric Weight Management Interventions for Use by Low-Income Families, Childhood Obesity Research Demonstration Project (CORD) 3.0

The overall goal of this study is to increase access to and adoption of the Healthy Weight Clinic package in primary care settings serving low income families in the United States who have a disproportionately high prevalence of childhood obesity. Two federally-qualified health centers in Mississippi and two health centers in Massachusetts will be implementing a Healthy Weight Clinic Program. The Healthy Weight Clinic is staffed by a medical provider, a Dietitian/Nutritionist, and a Community Healthy Worker. Patients attend individual medical visits (once per month for 12 months) with the multidisciplinary team, group visits led by a member of the team (once per month for 6 months), and phone follow-up between visits. All patients who receive care at the pilot implementation sites will be exposed to the systems-level intervention. A subset of patients will be invited to participate in a research evaluation of the program.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Behavioral: Healthy Weight Clinic

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meghan Perkins, MPH; Phone Number: 617-726-3841; Email: meperkins@mgh.harvard.edu
• Study Contact Backup: Name: Lauren Fiechtner, M.D.; Phone Number: 617-643-7247; Email: LFIECHTNER@PARTNERS.ORG

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• child is age 2 through 18 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 or Spanish
• received care at one of the participating pilot sites

Exclusion Criteria:

• children who do not have at least one parent who can report on their child's daily activities for 1 year
• families who plan to leave their pediatric health center in the next year
• children who have conditions or take medications that substantially interfere with growth, physical activity, or dietary recommendations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Clinically Based: Healthy Weight Clinic	Behavioral: Healthy Weight Clinic; Patients meet with a multi-disciplinary team over a 12 month period. In addition to the clinical visits, group visits, and phone calls, patients will also receive education materials, community resources, and an optional text messaging/social media library of messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child BMI at 12 months	Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.	0-12 months
Change in Child BMI percent of the 95th percentile at 12 months	Weight and height will be combined to report BMI in kg/m^2 based on CDC growth curves.	0-12 months
Change in Child BMI z-score at 12 months	Weight and height will be combined to report BMI z-score based on CDC growth curves	0-12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Child Quality of Life at 12 months based on Sizing Them Up Questionnaire	0-12 months
Change in Child Binge Eating at 12 months based on Questionnaire	0-12 months
Change in Child Parental Stress at 12 months based on Questionnaire	0-12 months
Change in Family Food Insecurity at 12 months based on Hunger Vital Signs Questionnaire	0-12 months
Change in Child Nutrition at 12 months based on Questionnaire	0-12 months
Change in Child Physical Activity at 12 months based on Questionnaire	0-12 months
Change in Child Sleep at 12 months based on Questionnaire	0-12 months
Change in Child Screen Time at 12 months based on Questionnaire	0-12 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Centers for Disease Control and Prevention; American Academy of Pediatrics

Publications and helpful links

General Publications

• Fiechtner L, Sierra Velez D, Ayala SG, Castro I, Lindros J, Perkins M, Baker A, Salmon J, Biggs V, Cannon-Smith G, Smith JD, Simione M, Gortmaker SL, Taveras EM. Planned Evaluation of the Healthy Weight Clinic Pediatric Weight Management and Implementation: Massachusetts-CORD 3.0. Child Obes. 2021 Sep;17(S1):S55-S61. doi: 10.1089/chi.2021.0178.
• Fiechtner L, Castro I, Ayala SG, Velez DS, Lindros J, Perkins M, Baker A, Salmon J, Biggs V, Cannon-Smith G, Smith JD, Simione M, Gortmaker SL, Taveras EM. Design and Approach of the Healthy Weight Clinic Pediatric Weight Management Intervention Package and Implementation: Massachusetts-CORD 3.0. Child Obes. 2021 Sep;17(S1):S48-S54. doi: 10.1089/chi.2021.0177.
• Sierra-Velez D, Gundewar A, Persaud A, Simione M, Castro I, Perkins M, Lindros J, Salmon J, Smith JD, Taveras EM, Fiechtner L. Stakeholders' perception of factors influencing adoption of a pediatric weight management intervention: a qualitative study. Front Public Health. 2023 Oct 13;11:1045618. doi: 10.3389/fpubh.2023.1045618. eCollection 2023.

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 12, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 2021P000258

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; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No