Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population
NCT ID: NCT05799222
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
20 participants
OBSERVATIONAL
2023-03-28
2026-11-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Bariatrix Meal Replacement Products
Meal replacement products offered through the Massachusetts General Hospital Weight Center.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bariatrix Meal Replacement Products
Meal replacement products offered through the Massachusetts General Hospital Weight Center.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chika V. Anekwe, MD, MPH
Instructor in Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chika V Anekwe, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Chika V Anekwe, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022P001451
Identifier Type: -
Identifier Source: org_study_id