My Best GI Eating Study
Colorectal Neoplasms
About this trial
This is an interventional health services research trial for Colorectal Neoplasms focused on measuring Prevention, Diet
Eligibility Criteria
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following 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
Excess adiposity as measured at the study screening visit
o Body mass index of 25-45 kg/m2
- Stable weight, within five pounds, in the last two months as determined by self-report
Increased risk of colorectal cancer as defined by one or more of the following:
- Prior adenomatous polyp
- Prior resected early-stage CRC (Stage I-IIIA or T1-3, N0-1, M0)
- History of CRC in at least one primary relative or in at least two secondary relatives
- 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.
- Have and use a compatible smartphone with a cellular data.
- Can be contacted by telephone for study support calls
- Read, write, 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 and a food frequency questionnaire by visit 2 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.
Exclusion Criteria:
- Persons with BMI >45.5 kg/m2 since very high BMI values could indicate more prevalent health problems.
- On medically prescribed diets or other medical contraindications to the study diets
- 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
- Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol
- Uncontrolled high blood pressure
- 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 2 years, except for basal cell or squamous cell tumors of the skin that have been surgically excised and required no further treatment
- Unable to read, write, or speak English
- Unable to give informed consent
- 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 DHQ3 (for example: <500 or >3500 kcal/day for women and <800 or >4200 kcal/day for men; or reporting too few foods eaten over the past year)
- Has an infectious disease at the present time.
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Eating Plan 1
Eating Plan 2
Eating Plan 3
This group will receive a pamphlet from the American Institute for Cancer Research (AICR) on dietary prevention and the results of their own breath test, Veggie Meter score and anthropometric measures.
This group will receive the MyBestGI App and User Manual that encourages limiting four food groups: three or less foods each day made with refined flour, no more than 8% of calories from added sugars, no processed meats and less than 18 oz./week red meat. They will also receive the results of their own breath test, Veggie Meter score and anthropometric measures.
This group will receive a version of the MyBestGI App and User Manual that encourages meeting 11 food group goals: four food groups to limit and seven food groups to encourage. The 7 groups to encourage are: 3-4 cups/day fruits and vegetables, at least one dark orange or dark green vegetable daily, daily allium and culinary herbs, 3-6 oz./day whole grains, 6-8 oz./week foods high in omega-3 fatty acids, 8-10 tsp./day olive oil or the equivalent from other foods high in monounsaturated fats and at least ½ cup/day of legumes or 1 TB/day nut butter. Some of the goals are personalized based on calculated energy needs. They will also receive the results of their own breath test, Veggie Meter score and anthropometric measures.