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

Obesity Clinical Trial

— MINT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799222
• Other study ID #: 2022P001451
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: July 18, 2024

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: Chika V Anekwe, MD
• Phone: 617-726-4400
• Email: canekwe[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 18, 2024
• Est. primary completion date: July 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Obesity
• Overweight
• PreDiabetes

Intervention

Dietary Supplement:
• Bariatrix Meal Replacement Products
Meal replacement products offered through the Massachusetts General Hospital Weight Center.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight reduction	Reduction in body weight by greater than or equal to 5 percent	3 months
Primary	Hemoglobin A1c reduction	Reduction of Hemoglobin A1c by greater than or equal to 0.5 percent	3 months
Secondary	Program adherence	Adherence with the program, and potential reasons for non-adherence as assessed with bi-weekly questionnaires	3 months