This randomized phase II trial will enroll overweight cancer survivors. Subjects in both groups will be educated to follow a diet pattern similar to what is recommended by the Dietary Guidelines for Americans and the American Institute for Cancer Research (DGA/AICR) but one group will also receive 18 ounces of lean beef for incorporation into a healthy diet. Subjects will be encouraged to exercise regularly and activity will be monitored throughout the study. Nutrition and exercise may help cancer survivors successfully maintain improved dietary patterns, body composition, and physical activity efforts and consumption of beef may favorably impact lean body mass and specific nutritional outcomes.
PRIMARY OBJECTIVES: I. To determine the feasibility and compliance with a the Dietary Guidelines for Americans/American Institute for Cancer Research (DGA/AICR) healthy dietary pattern and a beef + DGA/AICR healthy dietary pattern in cancer survivors. II. To determine the impact of dietary interventions on body composition, clinical outcomes, and physical performance. III. To quantify the impact of the two dietary interventions on cardiometabolic biomarkers of health. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive DGA/AICR-based dietary intervention for 6 months consisting of 12 education sessions over 60 minutes every other week, fruit, vegetable, and herb harvesting 1-2 times per week for 2 hours, wearing a FitBit during physical activity, and remote health coaching over 10 minutes for 12 weeks. ARM II: Patients receive DGA/AICR-based dietary intervention as in Arm I and consume 11-18 ounces of lean beef each week for 6 months. Clinical and physical activity assessments will take place at baseline, after the intervention and at 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
82
Participants randomized to the DGA/AICR group will receive plant-based diet education, garden access and health coaching for 5 months. The sessions are offered every other week.
Participants will wear a FitBit every day and monitor daily physical activity.
Correlative studies
Participants randomized to the beef group will receive 11 to 18 ounces of frozen lean beef each week for home preparation, in addition to DGA/AICR diet education, garden access and health coaching.
Ancillary studies
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Adherence to either the DGA/AICR group or the DGA/AICR + Beef group
Participants will keep both 7 day diet records periodically through out the study as well as a daily log of beef consumption
Time frame: Up to 12 months
Change in body composition
Change in body composition will be assessed by dual X-ray absorptiometry (iDXA)
Time frame: Up to 12 months
Change in blood pressure
Trained personnel will use a sphygomanometer to assess blood pressure
Time frame: Baseline up to 12 months
Change in body mass index (BMI)
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: Baseline up to 12 months
Change in dietary carotenoid intake
Assessed by Raman spectroscopy
Time frame: Baseline up to 12 months
Change in blood carotenoids
Assessed by High Pressure Liquid Chromatography
Time frame: Up to 12 months
Change in physical performance assessed by timed performance-related mobility tasks
Physical performance will be measured using the 40 M walk test
Time frame: Baseline up to 12 months
Change in physical performance
Assessed by a standardized stair climb test
Time frame: Up to 12 months
Dietary intake patterns
Will be assessed using diet logs maintained throughout the intervention and graphical food frequency questionnaire (FFQ). This FFQ automatically calculates the Healthy Eating Index 2010. Will use previous 30-day intake for all FFQs to assess dietary patterns. To determine protein balance, will use a 7-day diet record prior to a 24-hr urine collection.
Time frame: Up to 6 months
Adherence to classes
Descriptive statistics will be generated using attendance forms
Time frame: Up to 12 months
Change in fasting glucose
A fasting blood sample will be used to measure glucose at three time points
Time frame: Up to 12 months
Change in lipoprotein profiles
A fasting blood sample will be used to assess serum lipoprotein profile
Time frame: Up to 12 months
Daily physical activity (steps per day)
Each participants daily FitBit data will be downloaded to a secure spreadsheet
Time frame: up to 12 months
Health related quality of life
Measured at all three time points using the Health Related Quality of Life (HR-QOL) questionnaire
Time frame: Up to 12 months
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