Risk Informed Obesity Care Plan Pilot

June 11, 2025 updated by: Elsie Taveras, MD, Massachusetts General Hospital
The purpose of this research is to conduct a pilot of a risk-informed obesity care plan, implemented through pediatric primary care provider training via a Virtual Learning Collaborative (VLC) at MGH's Healthy Weight Clinic. We will evaluate HEDIS documentation and BMI outcomes among kids who receive care from the participating providers during and after the training period, compared to those who received care from the providers prior to the training.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be patients of medical providers participating in the MGH Healthy Weight Clinic and Asthma Control Program's Virtual Learning Community

Description

Inclusion Criteria:

  • Child 2-12 years of age at baseline
  • Child has overweight or obesity, based on their height/weight measurement
  • Child presented for primary care with a medical provider participating in the training

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Risk-informed obesity care plan
Children aged 2-12 years with overweight or obesity receiving primary care from a participating provider
Other: Risk-informed obesity care plan
A risk-informed obesity care plan, implemented through pediatric primary care provider training via a Virtual Learning Collaborative (VLC) will be deployed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HEDIS documentation codes
Time Frame: 0-6 months
0-6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in child Body Mass Index from baseline to 6 months
Time Frame: 0-6 months
0-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

June 11, 2025

First Submitted That Met QC Criteria

June 11, 2025

First Posted (Actual)

June 19, 2025

Study Record Updates

Last Update Posted (Actual)

June 19, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P001605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This retrospective data pull will be used for the evaluation of our aims, and is purposefully limited to only the required information. Interest parties can contact the PI to request IPD and the rationale for consideration on a case by case basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Childhood Obesity

Clinical Trials on Risk-informed obesity care plan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe