RECRUITING

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

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Conditions

OverweightPreDiabetesDiabetes Type 2Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-28
Study Completion:2025-11-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05799222

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-65
  2. * Body mass index (BMI) greater than or equal to 27 kg/m\^2
  3. * HgA1C greater than or equal to 5.7 percent or fasting glucose greater than or equal to 100mg/dL within the previous 6 months
  4. * Low-income as defined by having a family income at or below 400 percent of the federal poverty level guidelines for 2022
  1. * 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
  2. * HbA1c greater than or equal to 10 percent
  3. * Plans to pursue bariatric surgery over the 6 months post-study enrollment
  4. * Weight loss of greater than 5 kg within the previous 3 months
  5. * Current active eating disorder, with the exception of binge eating disorder
  6. * Severe active psychiatric disease or significant cognitive impairment deemed by investigator likely to impede adherence to piloted intervention
  7. * Active illicit substance abuse
  8. * Pregnant, breastfeeding, or considering pregnancy within the next 6 months
  9. * Current participation in another clinical research trial deemed by investigator to conflict with current study

Contacts and Locations

Study Contact

Chika V Anekwe, MD
CONTACT
617-726-4400
canekwe@mgh.harvard.edu

Principal Investigator

Chika V Anekwe, MD
PRINCIPAL_INVESTIGATOR
Mass General Brigham

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Chika V Anekwe, MD, PRINCIPAL_INVESTIGATOR, Mass General Brigham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-28
Study Completion Date2025-11-08

Study Record Updates

Study Start Date2023-03-28
Study Completion Date2025-11-08

Terms related to this study

Additional Relevant MeSH Terms

  • Overweight
  • PreDiabetes
  • Diabetes Type 2
  • Obesity