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Medically Intensive Nutrition Therapy for Obesity and Diabetes in Low-Income Individuals

This study is looking at how a special meal replacement program, called Bariatrix Meal Replacement Products, might help people with overweight, obesity, pre-diabetes, or type 2 diabetes who also have a low income. Researchers want to see if these meal replacements can help you lose weight and lower your blood sugar (measured by Hemoglobin A1c, or HbA1c) over 3 months. You could be eligible if you are between 18 and 65 years old, have a BMI (Body Mass Index) of 27 or higher, have an HbA1c of 5.7% or more, or a fasting glucose of 100mg/dL or more, and meet certain low-income guidelines. The study is currently unclear about its recruitment status and plans to enroll 20 participants.

Study design
This is an observational study, meaning researchers will watch and learn from participants without assigning them to different treatment groups. It aims to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goals are measured at 3 months, which indicates the study will follow participants for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05799222

Medically Intensive Nutrition Therapy Program for Obesity and Diabetes in a Low-income Population

Recruiting
Not specifiedAges 18–65Observational
Massachusetts General Hospital
~20 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:Bariatrix Meal Replacement Products

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body weight reduction
Measured over 3 months
+1 more outcome measured

Conditions

Overweight
PreDiabetes
Diabetes Type 2
Obesity

Explore related trials

ObesityOverweightPrediabetesType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Chika V Anekwe, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Chika V Anekwe, MD
[email protected]
617-726-4400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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
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

What this trial measures

  • Body weight reduction3 months

    Reduction in body weight by greater than or equal to 5 percent

  • Hemoglobin A1c reduction3 months

    Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent