Pediatric Healthy Weight Clinic

NCT ID: NCT05020314

Last Updated: 2025-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pediatric Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clinically Based: Healthy Weight Clinic

Group Type EXPERIMENTAL

Healthy Weight Clinic

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

American Academy of Pediatrics

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lauren G. Fiechtner, M.D.

Director of Nutrition, Division of Gastroenterology and Pediatric Health Outcomes Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 34569842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34569841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37900042 (View on PubMed)

Other Identifiers

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2021P000258; 2023P003302

Identifier Type: -

Identifier Source: org_study_id

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