MyGI Diet for Colorectal Cancer Prevention

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

• Persons 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

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Rob Adwere-Boamah, MA
MyBestGIstudy@umich.edu
734-232-4971
Time Frame
Start Date: 2023-06-13
Estimated Completion Date: 2026-11
Participants
Target number of participants: 240
Treatments
Active_comparator: Eating Plan 1
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.
Experimental: Eating Plan 2
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.
Experimental: Eating Plan 3
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.
Sponsors
Leads: University of Michigan
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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