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

NCT05799222 | Recruiting

• 1 other identifier: 2022P001451
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Body weight reduction

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

  3 months

• Hemoglobin A1c reduction

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

  3 months

Secondary Outcomes (1)

• Program adherence

  3 months

Study Arms (1)

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.

Dietary Supplement: Bariatrix Meal Replacement Products

Interventions

Bariatrix Meal Replacement Products DIETARY_SUPPLEMENT

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

Adults with overweight/obesity and pre-diabetes/diabetes and low income

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with overweight or obesity and pre-diabetes or diabetes and low income

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participants may choose to take part in an optional collection of stored blood.

MeSH Terms

Conditions

Overweight; Prediabetic State; Diabetes Mellitus, Type 2; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chika V Anekwe, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chika V Anekwe, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 5, 2023
• Study Start: March 28, 2023
• Primary Completion (Estimated): November 8, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)