NCT07028814

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Apr 2025Jul 2026

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

June 19, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

June 11, 2025

Last Update Submit

June 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • HEDIS documentation codes

    0-6 months

Secondary Outcomes (1)

  • Change in child Body Mass Index from baseline to 6 months

    0-6 months

Study Arms (1)

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

Interventions

A risk-informed obesity care plan, implemented through pediatric primary care provider training via a Virtual Learning Collaborative (VLC) will be deployed.

Risk-informed obesity care plan

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Community Health & Health Equity Officer

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 19, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

June 19, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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.

Locations