A program to help people eat healthier to prevent colorectal cancer
MyGI Diet for Colorectal Cancer Prevention
This study is testing different healthy eating plans to see if they can help overweight people at risk for colorectal cancer improve their diets and lose weight over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05396846 on ClinicalTrials.gov |
What this trial studies
The MyBestGI study evaluates three different dietary interventions aimed at promoting healthier eating habits among overweight and obese individuals at risk for colorectal cancer. Participants will follow one of the eating plans for 12 months, with support provided through telephone calls and a web-based app. The study aims to assess improvements in dietary habits and weight changes, while also exploring how these changes affect metabolic pathways. All participants will receive personalized feedback based on their dietary assessments throughout the study.
Who should consider this trial
Good fit: Ideal candidates include overweight or obese adults aged 19 and older with specific risk factors for colorectal cancer.
Not a fit: Patients who are not overweight or do not have risk factors for colorectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective dietary strategies to reduce the risk of colorectal cancer in at-risk populations.
How similar studies have performed: Previous studies have shown that dietary interventions can significantly impact cancer risk, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Men and women ages 19 and older * The subject has been properly informed of the study, they agree to participate, and sign the Informed Consent document(s) * Measured body mass index of 25-45 kg/m2 at the study eligibility visit months OR waist circumference \> 88 cm for women or \> 102 cm for men. * Reasonably stable weight in the last two months * Increased risk of colorectal cancer as defined by: Prior adenomatous polyp or serrated polyp OR prior resected early stage CRC (Stage I-IIIA or T1-3, N0-1, M0) OR a history of CRC in at least one primary relative or in at least two secondary relatives OR a polyp was found with a recommended follow-up colonoscopy in less than 8 years OR A known genetic condition that increases risk of CRC * Good general health * Have reasonable control over their own dietary intakes * Not expecting major lifestyle changes in the next 12 months. * Not expecting a change in hormonal therapies over the next 12 months * Have and use a smartphone with web access * Can be contacted by telephone for support calls * Read and speak English * Are able to follow a diet high in fiber-containing foods * Agree to be randomized to a control condition of usual care versus a dietary intervention involving app use and telephone contacts * Successfully complete three 24-hour dietary recalls online prior to baseline with plausible dietary intakes * If taking medications for conditions that are affected by diet (diabetes, high blood pressure) must be willing to continue to follow-up with their personal medical provider as needed to manage those conditions and the medication dosing, which may need to be adjusted due to diet changes. * Has been properly informed of the study and signed the Informed Consent document Exclusion Criteria: * Persons with BMI \>45 kg/m2 since very high BMI values could indicate more prevalent health problems. * On medically prescribed diets or other medical contraindications to dietary modification * Are within 12 months of bariatric surgery * Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol * Taking anti-coagulants that interfere with ability to obtain a blood sample * 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 * Have cancer at the present time * Dietary intakes with substantial nutrient deficiencies that would require extensive counseling to correct, such as obtaining a large portion of calories from alcohol * Unable to make their own daily food choices * 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) * 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) * Has an infectious disease at the present time (such as HIV or hepatitis C). * Unable to read, write, or speak English * Unable to give informed consent
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Rob Adwere-Boamah, MA
- Email: MyBestGIstudy@umich.edu
- Phone: 734-232-4971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.