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

Description

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

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Study Overview

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Study Details

Study overview

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.

Feasibility Study of an Intensive Nutrition Therapy Program for Improvement of Obesity and Diabetes in a Low-income Population

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

Condition
Overweight
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Chika V Anekwe, MD, PRINCIPAL_INVESTIGATOR, Mass General Brigham

Study Record Dates

2025-11-08