Nutrition and Exercise Trial: Improving Diet and Physical Activity Patterns in Overweight Cancer Survivors
NCT03489213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2019-08-30
Summary
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.
Conditions
- Cancer Survivor
- Overweight
Interventions
- OTHER
-
Dietary Intervention
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.
- BEHAVIORAL
-
Exercise Intervention
Participants will wear a FitBit every day and monitor daily physical activity.
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DIETARY_SUPPLEMENT
-
Nutritional Intervention
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.
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Steven Clinton, MD · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-04-25
- Primary Completion
- 2018-06-01
- Completion
- 2019-06-01
Countries
- United States
Study Locations
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