Childhood ObesityNCT07028814
Risk Informed Obesity Care Plan Pilot
An observational study of Childhood Obesity, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Risk-informed obesity care plan
- How many people
- 720 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be patients of medical providers participating in the MGH Healthy Weight Clinic and Asthma Control Program's Virtual Learning Community
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Childhood Obesity
- Being tested
- Risk-informed obesity care plan
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-informed obesity care planOther
A risk-informed obesity care plan, implemented through pediatric primary care provider training via a Virtual Learning Collaborative (VLC) will be deployed.
| Study group | Role | What they receive |
|---|---|---|
| Risk-informed obesity care plan | Children aged 2-12 years with overweight or obesity receiving primary care from a participating provider Receives: Other: Risk-informed obesity care plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEDIS documentation codes
Measured: 0-6 months
Secondary outcomes (1)
Change in child Body Mass Index from baseline to 6 months
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Apr 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elsie Taveras, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028814
- Sponsor's protocol ID
- 2025P001605
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Informed Obesity Care Plan Pilot
- ClinicalTrials.gov ID
- NCT07028814
- Acronym / sponsor ID
- 2025P001605
- Conditions
- Childhood Obesity
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk-informed obesity care plan | – | Other: Risk-informed obesity care planChildren aged 2-12 years with overweight or obesity receiving primary care from a participating provider |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be patients of medical providers participating in the MGH Healthy Weight Clinic and Asthma Control Program's Virtual Learning Community
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-informed obesity care planA risk-informed obesity care plan, implemented through pediatric primary care provider training via a Virtual Learning Collaborative (VLC) will be deployed. | Other | Risk-informed obesity care plan |
Primary outcome
HEDIS documentation codes
Time frame: 0-6 months
1 secondary outcome
Change in child Body Mass Index from baseline to 6 months
Time frame: 0-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEDIS documentation codes (time frame: 0-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.