COMPLETED

The Breakfast Study

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

The investigators will conduct an acceptability, feasibility, preliminary effectiveness trial of a 4-month, online, very low-carbohydrate breakfast-focused program in 120 adults with type 2 diabetes. The investigators will measure acceptability and feasibility, plus critical efficacy outcomes, such as changes in HbA1c, anti-hyperglycemic medications, glycemic variability, body weight, blood pressure, and lipids.

Official Title

The Breakfast Study: A Small Steps, Low-literacy, Breakfast-focused Dietary Self-management Intervention for Adults With Poorly Controlled Type 2 Diabetes

Quick Facts

Study Start:2023-08-02
Study Completion:2025-10-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05986097

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 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * HbA1c 7% or higher
  2. * 18-80 years old
  3. * The ability to understand verbal and written English
  4. * Willingness to follow the prescribed diet
  5. * Able to consent and follow directions
  6. * Willingness to regularly check blood glucose levels as required
  1. * Inability to provide informed consent
  2. * Pregnant, breastfeeding, or planning for either in the next 6 months or \<6 months postpartum
  3. * Low C-peptide and possible subsequent GAD 65 level that suggests type 1 diabetes, clinical factors that suggest type 1 diabetes (lean, lack of family history, and diabetic ketoacidosis in the past) or a previous diagnosis of type 1 diabetes or latent autoimmune diabetes
  4. * Cancer, heart failure, or kidney failure
  5. * Vegan
  6. * Untreated mental health condition
  7. * Currently following a very low-carbohydrate diet or breakfasts
  8. * Thyroid levels out of range
  9. * Alcoholism
  10. * Previous bariatric surgery
  11. * Difficulty chewing or swallowing
  12. * Dependence on others for food preparation
  13. * Currently enrolled in another investigative study that might conflict with this research

Contacts and Locations

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

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 Date2023-08-02
Study Completion Date2025-10-17

Study Record Updates

Study Start Date2023-08-02
Study Completion Date2025-10-17

Terms related to this study

Keywords Provided by Researchers

  • Very low carbohydrate diet
  • Nutrition therapy

Additional Relevant MeSH Terms

  • Type 2 Diabetes