This clinical trial evaluates three different methodsin addition to MyBestGI application (app) that could be used for achieving and maintaining an eating style that is thought to reduce the chances of developing colon or rectal cancer. Colorectal cancer (CRC) is one of the cancers most strongly affected by diet. Recommendations for cancer prevention from the American Cancer Society and American Institute for Cancer Research include advice to maintain a healthy weight, to consume more plant-based foods, and to limit red meats, processed meats, and foods with added sugar. Despite the research that supports the role of diet in prevention, this has had little impact on the medical care of individuals who are at increased risk of cancer. The three eating plans being tested in this study all focus on improving food choices consistent with the recommendations for cancer prevention, and this might result in some weight loss over time. The MyBestGI app includes educational material, several types of messages (reminder to track messages, congratulatory messages, educational tips, and administrative messages for appointment reminders and reminders for performing online assessments). These methods would be simple to administer in medical settings with minimal in-person support. If successful, the researchers hope that one or more of the three methods will be utilized more broadly in the future as part of usual, preventive medical care.
Additional locations may be listed on ClinicalTrials.gov for NCT05396846.
Locations matching your search criteria
United States
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer CenterStatus: Active
Contact: Zora Djuric
Phone: 734-936-4494
PRIMARY OBJECTIVE:
I. To determine if an intervention limiting Western foods (Eating Plan 2) has similar effects as a more comprehensive intervention (Eating Plan 3), versus control, on the dual outcomes of improving diet and achieving modest weight loss in overweight and obese subjects at increased risk of CRC.
EXPLORATORY OBJECTIVES:
I. Other biological indicators of dietary change.
II. To evaluate whether skin carotenoids and breath ketones can be utilized as non-invasive, objective measures of dietary compliance for future use in reinforcing dietary changes.
III. Genetic information related to nutrient metabolism.
IV. To explore whether usage of the MyBestGI app is related to dietary compliance as measured by the preventative food (PF) score and weight change.
V. Behavioral factors that could affect intervention efficacy.
SUB-STUDY OBJECTIVES:
I. To collect data on whether implementing the MyBestGI program might be optimized by starting with Eating Plan 2 and then moving to Eating Plan 3 afterwards.
II. To collect data on whether Eating Plan 2 might be a reasonable maintenance strategy for people who have completed one year following the more complex Eating Plan 3.
III. To collect data on MyBestGI program and app use without coaching support in persons who never used one of the MyBestGI interventional eating plans and app, seeing how MyBestGI app functions under more real world conditions.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I: Participants receive a pamphlet from the American Institute for Cancer Research (AICR) on dietary prevention on study. Participants also undergo anthropometrics measurements, carotenoid measurements, and blood and breath sample collection on study.
GROUP II: Participants participate in Eating Plan 2 with four goals to limit common “Western” foods on study. Participants use the MyBestGI app to track dietary intake 3 days a week during weeks 1-12 and 3 days every other week during weeks 13-52 and receive 20 minute support calls at weeks 1, 2, 4, 8, 12, 16, 24, 32, 40 and 48. Participants also undergo anthropometrics measurements, carotenoid measurements, and blood and breath sample collection on study.
GROUP III: Participants participate in Eating Plan 3 with four goals to limit Western foods from Eating Plan 2 in addition to seven goals of foods to encourage on study. Participants use the MyBestGI app to track dietary intake 3 days a week during weeks 1-12 and 3 days every other week during weeks 13-52 and receive 20 minute support calls at weeks 1, 2, 4, 8, 12, 16, 24, 32, 40 and 48. Participants also undergo anthropometrics measurements, carotenoid measurements, and blood and breath sample collection on study.
SUBSTUDY: Patients who completed the full 12 month participation in the main study may enroll in the substudy. Main study participants in group I are randomized to substudy group 1 or 2. Main study participants in group II are assigned to substudy group 2 and main study participants in group III are assigned to substudy group 1.
SUBSTUDY GROUP 1: Participants participate in Eating Plan 2 with four goals to limit common “Western” foods on study. Participants use the MyBestGI app to track dietary intake 3 days a week during weeks 1-12 and 3 days every other week during weeks 13-52,
SUBSTUDY GROUP 2: Participants participate in Eating Plan 3 with four goals to limit Western foods from Eating Plan 2 in addition to seven goals of foods to encourage on study. Participants use the MyBestGI app to track dietary intake 3 days a week during weeks 1-12 and 3 days every other week during weeks 13-52.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUniversity of Michigan Comprehensive Cancer Center
Principal InvestigatorZora Djuric
