CClinicalTrials.gg
Enrolling by invitationNCT07028814Updated Jun 19, 2025

Risk Informed Obesity Care Plan Pilot

An observational study in Childhood Obesity, sponsored by Massachusetts General Hospital. Enrolling by invitation at 1 site in United States. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-06-19.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
720
Ages
2 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Childhood Obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 720 is above the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 12 Years
Sexes eligible
All
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

Eligibility criteria

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
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
720 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherRisk-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.

06

What researchers measure

Primary outcomes

  1. HEDIS documentation codes

    Time frame: 0-6 months

Secondary outcomes

  1. Change in child Body Mass Index from baseline to 6 months

    Time frame: 0-6 months

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07028814
Lead sponsor
Massachusetts General Hospital
Responsible party
Elsie Taveras, MD (Chief Community Health & Health Equity Officer, Massachusetts General Hospital) — Principal investigator
First posted
Jun 19, 2025
Start date
Apr 1, 2025
Primary completion
Jul 31, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
Jun 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion