OverweightMINTNCT05799222
Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
An observational study of Overweight and PreDiabetes, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight and diabetes/pre-diabetes who have a low income. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, PreDiabetes, Diabetes Type 2
- What is being tested?
- Bariatrix Meal Replacement Products
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2023to 10 Nov 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with overweight or obesity and pre-diabetes or diabetes and low income
Who may be able to join
- Age 18-65
- Body mass index (BMI) greater than or equal to 27 kg/m^2
- HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg/dL within the previous 6 months
- Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022
Who cannot join
- Current use of antihyperglycemic agents (other than metformin) or approved anti- obesity medications or plans to start such regimens over the 3 months post-study enrollment
- HbA1c greater than or equal to 10 percent
- Plans to pursue bariatric surgery over the 6 months post-study enrollment
- Weight loss of greater than 5 kg within the previous 3 months
- Current active eating disorder, with the exception of binge eating disorder
- Severe active psychiatric disease or significant cognitive impairment deemed by investigator likely to impede adherence to piloted intervention
Show all 9Show fewer
- Active illicit substance abuse
- Pregnant, breastfeeding, or considering pregnancy within the next 6 months
- Current participation in another clinical research trial deemed by investigator to conflict with current study
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, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Chika V Anekwe, MD, 617-726-4400, canekwe@mgh.harvard.edu
About this study
Official title: Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population
This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight and diabetes/pre-diabetes who have a low income.
Read the detailed description
The Medically Intensive Nutritional Therapy (MINT) program at Massachusetts General Hospital (MGH) Weight Center is a low-calorie nutrition plan that may offer a solution for those who have difficulty implementing a low-calorie dietary plan on their own. This study examines the effects of MINT on weight loss and blood sugar control specifically in a low-income population and explores potential reasons for discontinuing the program.
- Conditions
- Overweight, PreDiabetes, Diabetes Type 2, Obesity
- Being tested
- Bariatrix Meal Replacement Products
- Medical subject headings
- Overweight, Prediabetic State, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatrix Meal Replacement ProductsDietary supplement
Meal replacement products offered through the Massachusetts General Hospital Weight Center.
| Study group | Role | What they receive |
|---|---|---|
| Adults with overweight/obesity and pre-diabetes/diabetes and low income | Adults with overweight or obesity and pre-diabetes or type 2 diabetes who earn a low income. Receives: Dietary Supplement: Bariatrix Meal Replacement Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight reduction
Reduction in body weight by greater than or equal to 5 percent
Measured: 3 months
Hemoglobin A1c reduction
Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent
Measured: 3 months
Secondary outcomes (1)
Program adherence
Adherence with the program, and potential reasons for non-adherence as assessed with bi-weekly questionnaires
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start28 Mar 2023
- Primary completion8 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chika V. Anekwe, MD, MPH, Massachusetts General Hospital
- Investigators
- Chika V Anekwe, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799222
- Sponsor's protocol ID
- 2022P001451
- Acronym
- MINT
- Status last verified
- Dec 2025
- First submitted
- 3 Mar 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD plan.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population
- ClinicalTrials.gov ID
- NCT05799222
- Acronym / sponsor ID
- MINT / 2022P001451
- Conditions
- Overweight, PreDiabetes, Diabetes Type 2, Obesity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 8 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 5 Apr 2023 (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.
This study is being done to better understand whether meal replacements can be an effective tool for weight loss and treatment of elevated blood sugars in people with obesity/overweight and diabetes/pre-diabetes who have a low income.
Detailed description
The Medically Intensive Nutritional Therapy (MINT) program at Massachusetts General Hospital (MGH) Weight Center is a low-calorie nutrition plan that may offer a solution for those who have difficulty implementing a low-calorie dietary plan on their own. This study examines the effects of MINT on weight loss and blood sugar control specifically in a low-income population and explores potential reasons for discontinuing the program.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with overweight/obesity and pre-diabetes/diabetes and low income | – | Dietary Supplement: Bariatrix Meal Replacement ProductsAdults with overweight or obesity and pre-diabetes or type 2 diabetes who earn a low income. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with overweight or obesity and pre-diabetes or diabetes and low income
Key inclusion criteria (4 listed)
- Age 18-65
- Body mass index (BMI) greater than or equal to 27 kg/m^2
- HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg/dL within the previous 6 months
- Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022
Key exclusion criteria (9 listed)
- Current use of antihyperglycemic agents (other than metformin) or approved anti- obesity medications or plans to start such regimens over the 3 months post-study enrollment
- HbA1c greater than or equal to 10 percent
- Plans to pursue bariatric surgery over the 6 months post-study enrollment
- Weight loss of greater than 5 kg within the previous 3 months
- Current active eating disorder, with the exception of binge eating disorder
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 |
|---|---|---|
| Bariatrix Meal Replacement ProductsMeal replacement products offered through the Massachusetts General Hospital Weight Center. | Dietary supplement | Adults with overweight/obesity and pre-diabetes/diabetes and low income |
Primary outcome
Body weight reduction
Time frame: 3 months
Reduction in body weight by greater than or equal to 5 percent
Hemoglobin A1c reduction
Time frame: 3 months
Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent
1 secondary outcome
Program adherence
Time frame: 3 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 24 Dec 2025.
- Individual participant dataSharing planned: No. There is no IPD plan.
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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.
Chika V Anekwe, MD principal investigator
Massachusetts General Hospital
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 Overweight and PreDiabetes, 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 24 Dec 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?
Contact Chika V Anekwe, MD (617-726-4400, canekwe@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight reduction (time frame: 3 months). The study lists 2 primary outcomes in all. 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 24 Dec 2025.