Recruiting

Nutrition Therapy

Sponsor:

Massachusetts General Hospital

Code:

NCT05799222

Conditions

Overweight

PreDiabetes

Diabetes Type 2

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Bariatrix Meal Replacement Products

Study Details

Brief 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.

Conditions

Overweight

PreDiabetes

Diabetes Type 2

Obesity

Study ID

NCT05799222

Start date

Mar 28, 2023

Status verified date

Dec, 2025

Completion date

Nov 10, 2026

Anticipated

Primary completion date

Nov 8, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Bariatrix Meal Replacement Products

Meal replacement products offered through the Massachusetts General Hospital Weight Center.

Primary outcome measure

  • Body weight reduction [ Time Frame: 3 months ]
  • Hemoglobin A1c reduction [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Chika V Anekwe, MD

617-726-4400canekwe@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Chika V Anekwe, MD

617-726-4400canekwe@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-12-24.