ACTIVE_NOT_RECRUITING

My Best GI Eating 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 MyBestGI study evaluates three different approaches that could help people eat in healthier ways. The study seeks to enroll 240 overweight and obese persons who have risk factors for colorectal cancers such as a family or personal history of colorectal cancers or adenomatous polyps. The study website is www.MyBestGI.org . Participants in the study will be asked to follow one of three eating plans, as best they can, for 12 months. Study participants can choose the foods they prefer within healthy food groups. Two of the eating plans involve ten brief telephone support calls and use of a web-based app (MyBestGI App). The study primarily evaluates improvements in eating and any weight change that may result. Secondary goals for the research are to evaluate how changes in eating affect metabolic pathways. All study participants will receive written materials that encourage making room for preventive foods in your daily eating. All participants also receive the results of their own diet analyses, and results of their own measures at study visits. The measures are the Veggie Meter skin reflectance test, Ketoscan breath test, and body composition measures. Study visits also involve providing a small blood sample from the arm. Study visits are in Ann Arbor at the start of the study, and at 6 and 12 months. The long-term goal of this research is to provide better options for supporting individuals who seek to achieve and maintain a preventive style of eating.

Official Title

MyGI Diet for Colorectal Cancer Prevention

Quick Facts

Study Start:2023-06-13
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05396846

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:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Persons with BMI \>45 kg/m2 since very high BMI values could indicate more prevalent health problems.
  2. * On medically prescribed diets or other medical contraindications to dietary modification
  3. * Are within 12 months of bariatric surgery
  4. * Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol
  5. * Taking anti-coagulants that interfere with ability to obtain a blood sample
  6. * Has a history of cytotoxic treatment (radiation, chemotherapy) for any type cancer within the last 12 months, except for basal cell or squamous cell tumors of the skin that have been surgically excised and required no further treatment
  7. * Have cancer at the present time
  8. * Dietary intakes with substantial nutrient deficiencies that would require extensive counseling to correct, such as obtaining a large portion of calories from alcohol
  9. * Unable to make their own daily food choices
  10. * Showing evidence of lack of reliability or non-adherence to study procedures (for example, missing an eligibility screening or baseline enrollment appointment more than twice; unable to recall the previous day's diet)
  11. * Reported dietary intakes reported that are not plausible or highly unusual as reported on the ASA24 (for example: \<500 or \>3500 kcal/day for women and \<800 or \>4200 kcal/day for men; or reporting too few foods eaten)
  12. * Has an infectious disease at the present time (such as HIV or hepatitis C).
  13. * Unable to read, write, or speak English
  14. * Unable to give informed consent

Contacts and Locations

Principal Investigator

Zora Djuric, PhD
STUDY_CHAIR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Zora Djuric, PhD, STUDY_CHAIR, 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 Date2023-06-13
Study Completion Date2026-11

Study Record Updates

Study Start Date2023-06-13
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Prevention
  • Diet

Additional Relevant MeSH Terms

  • Colorectal Neoplasms