My Best GI Eating Study
Study Details
Study Description
Brief Summary
This proposal seeks to develop methods that could be used in medical settings to assist high risk individuals in attaining both the weight management and diet quality goals for prevention of colorectal (CRC) cancer. This study tests two different dietary interventions versus a control group in overweight and obese persons who are at increased risk of CRC. The study will recruit 240 study participants. Participants will be randomized to receive to 12 months of a: 1) Self-Guided Eating Plan, a control group that receives written information on cancer preventive diets from the American Institute for Cancer Research (The New American Plate brochure), 2) a Simple Eating Plan that simply encourages a limit on four Western food groups associated with increased risk of CRC to make room for better choices, or 3) a Full Eating Plan that combines goals for both limiting Western foods and consuming preventive foods to achieve a modified Mediterranean type of diet. The dietary changes are expected to improve diet quality and achieve a sustainable, slow rate of weight loss over time that is likely more favorable for cancer prevention than conventional obesity treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Despite the large body of research that has identified the impact of diet on cancer risk, little has been done to translate these findings to clinical settings. Here we address prevention of colorectal cancer (CRC), the third most prevalent cancer in the U.S. CRC is among the cancers that are most strongly affected by diet and excess adiposity, and incidence is increasing in young people below the age of 40. More efforts need to be directed at providing individuals with the tools needed for achieving and maintaining a preventive 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. This proposal addresses the development of methods that could feasibly be implemented in medical settings to assist high risk individuals in attaining both the weight management and diet quality goals for prevention of CRC. Building on previous trials, this proposal seeks to test two dietary interventions in overweight and obese persons who have a strong family history of CRC or a personal history of CRC. The study will recruit 240 participants who will be randomized to receive to 12 months of: 1) a control group that receives written information on preventive diets; 2) a Simple Eating Plan that simply encourages limiting Western foods associated with increased risk of CRC: ultra-processed foods (foods containing refined flour, added sugars, or processed meats) and red meats; or 3) a Full Eating Plan that combines goals for both limiting Western foods and consuming preventive foods. The two interventions will be supported by written educational materials, brief telephone contacts by case managers, and a different module of the MyGI app for each diet. MyGI incorporates checklists to facilitate real-time goal tracking, tailored messaging, and real-time display of progress made. The dietary changes are expected to improve diet quality and achieve a sustainable, slow rate of weight loss over time that appears to be more favorable for cancer prevention than conventional obesity treatment. The specific aims are: 1) To determine if an intervention limiting Western foods has similar effects as a more comprehensive intervention, versus control, on the dual primary outcomes of improving diet and achieving modest weight loss in overweight and obese subjects at increased risk of CRC. Secondary outcomes include biological and behavioral measures of intervention adherence, app usability, and serum markers of inflammatory stress. 2) To evaluate whether skin carotenoids (as a biomarker of fruit and vegetables consumption) and breath ketones (as a biomarker of fat oxidation) can be utilized as non-invasive, objective measures of dietary compliance. The long-term goal is to identify an intervention that could be incorporated as part of usual health maintenance care to help high risk patients meet and maintain dietary cancer prevention goals.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Self-Guided Eating Plan 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, skin carotenoid score and anthropometric measures. |
Behavioral: Self-Guided Eating Plan
The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.
|
| Experimental: Simple Eating Plan The Simple Eating Plan group will receive a version of the MyBestGI App and User Manual that encourages limiting four common "Western" 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, skin carotenoid score and anthropometric measures. |
Behavioral: Simple Eating Plan
The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.
|
| Experimental: Full Eating Plan The Full Eating Plan group will receive a version of the MyBestGI App and User Manual that encourages meeting 11 food group goals: four goals to limit Western foods and seven goals of foods to encourage. Those 7 goals 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, skin carotenoid score and anthropometric measures. |
Behavioral: Full Eating Plan
The goal is to follow a preventive style of eating that is thought to lower the risk of colorectal cancers.
|
Outcome Measures
Primary Outcome Measures
- Preventive Food Score [Change over 12 months]
a score of 10 dietary components (0-10, with 10 being the most optimal score)
- Weight Loss [Change over 12 months]
change in weight from baseline (in pounds)
Other Outcome Measures
- Breath Ketone Concentration [Change over 12 months]
LEVL measure
- Skin Carotenoids [Change over 12 months]
Veggie Meter reading
Eligibility Criteria
Criteria
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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Men and women ages 19 and older
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The subject has been properly informed of the study, they agree to participate, and sign the Informed Consent document
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Excess adiposity as measured at the study screening visit
o Body mass index of 25-45 kg/m2
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Stable weight, within five pounds, in the last two months as determined by self-report
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Increased risk of colorectal cancer as defined by one or more of the following:
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Prior adenomatous polyp
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Prior resected early-stage CRC (Stage I-IIIA or T1-3, N0-1, M0)
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History of CRC in at least one primary relative or in at least two secondary relatives
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A known genetic condition that increases risk of CRC
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Good general health
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Have reasonable control over their own dietary intakes
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Not expecting major lifestyle changes in the next 12 months.
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Have and use a compatible smartphone with a cellular data.
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Can be contacted by telephone for study support calls
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Read, write, and speak English
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Are able to follow a diet high in fiber-containing foods
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Agree to be randomized to a control condition of usual care versus a dietary intervention involving app use and telephone contacts
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Successfully complete three 24-hour dietary recalls and a food frequency questionnaire by visit 2 with plausible dietary intakes
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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:
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Persons with BMI >45.5 kg/m2 since very high BMI values could indicate more prevalent health problems.
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On medically prescribed diets or other medical contraindications to the study diets
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Dietary intakes with substantial nutrient deficiencies that would require extensive counseling to correct, such as obtaining a large portion of calories from alcohol
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Unable to make their own daily food choices
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Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol
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Uncontrolled high blood pressure
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Taking anti-coagulants that interfere with ability to obtain a blood sample
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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
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Unable to read, write, or speak English
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Unable to give informed consent
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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)
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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)
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Has an infectious disease at the present time.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Cancer Institute (NCI)
Investigators
- Study Chair: Zora Djuric, PhD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00197337
- R01CA255743