Pediatric Healthy Weight Clinic

NCT05020314 | Completed

• 1 other identifier: 2021P000258; 2023P003302
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (1)

Clinically Based: Healthy Weight Clinic

EXPERIMENTAL

Behavioral: Healthy Weight Clinic

Interventions

Healthy Weight Clinic BEHAVIORAL

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.

Clinically Based: Healthy Weight Clinic

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Centers for Disease Control and Prevention: collaborator
• American Academy of Pediatrics: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

• 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.

  PMID: 34569842 BACKGROUND

• 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.

  PMID: 34569841 BACKGROUND

• 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.

  PMID: 37900042 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nutrition, Division of Gastroenterology and Pediatric Health Outcomes Research

Model Details: Children receiving care at the implementation sites, and who are referred to and attend the Healthy Weight Clinic will receive the intervention as described. A sample of demographically matched children who did not receive the intervention will serve as a comparison group.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 25, 2021
• Study Start: October 7, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

US (1)