Nutrition and Exercise Trial: Improving Diet and Physical Activity Patterns in Overweight Cancer Survivors
NCT ID: NCT03489213
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2017-04-25
2019-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm I (DGA/AICR)
Patients receive DGA/AICR-based dietary intervention for 6 months consisting of 12 education sessions (60 minutes each) every other week. Lectures will take place in an urban garden where fruit, vegetable, and herb harvesting 1-2 times per week is encouraged. All participants will be given a FitBit and regular physical activity will be encouraged. Finally, remote health coaching is offered to all study subjects for the duration of the intervention (12 weeks).
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.
Exercise Intervention
Participants will wear a FitBit every day and monitor daily physical activity.
Laboratory Biomarker Analysis
Correlative studies
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.
Questionnaire Administration
Ancillary studies
Arm II (DGA/AICR plus Beef)
Patients receive the same intervention as in Arm I with the addition of 18 ounces of lean beef provided by the study to each subject. Subjects will be encouraged to consume the lean beef and lectures will incorporate healthy beef consumption into each lesson and cooking demonstration.
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.
Exercise Intervention
Participants will wear a FitBit every day and monitor daily physical activity.
Laboratory Biomarker Analysis
Correlative studies
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.
Questionnaire Administration
Ancillary studies
Interventions
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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.
Exercise Intervention
Participants will wear a FitBit every day and monitor daily physical activity.
Laboratory Biomarker Analysis
Correlative studies
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.
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be non-vegetarian/non-vegan, and have no concerns with beef consumption
* Have completed active curative therapy for cancer within the past 36 months (i.e., surgery, chemotherapy, or radiation); ongoing hormone therapy is acceptable
* Voluntarily provide consent, Health Insurance Portability and Accountability Act (HIPPA) authorization form, and consent from primary care provider (PCP) or treating oncologist
* Not be planning to travel for more than 3 consecutive weeks during the intervention period
* Agree to refrain from all nutritional supplements, herbal supplements, and botanical supplements aside from those prescribed by a physician for the duration of the study
Exclusion Criteria
* Are vegan or those unwilling to consume 11-18 ounces (oz) of beef per week
* Have pre-existing medical conditions that preclude unsupervised physical activity (i.e., severe orthopedic conditions, impending hip or knee replacement, paralysis, unstable angina, dementia, recent history of myocardial infarction, congestive heart failure, pulmonary conditions requiring oxygen, or hospitalization in past 6 months)
* Have had cancer treatment that significantly impacts digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon, pancreas dysfunction, or brain surgery that alters cognition, etc.)
* Report meeting the recommendations for physical activity (\> 60 minutes per day, most days per week) and already meet the majority of dietary guidelines as assessed by a telephone screener
* Are prescribed medication that do not allow for increased intake of fruits and vegetables
* Have recently (\< 3 months) started a statin or other lipid lowering medication; participants who report that they are changing a lipid lowering drug dose or drug type during the recruitment period will also be excluded; participants who have been stable on a lipid-lowering medication for at least 3 months may participate; well-controlled diabetics (type I or II) may participate
* Have been diagnosed with active metabolic or digestive illnesses (i.e., Celiac disease, irritable bowel syndrome \[IBS\], renal insufficiency, hepatic insufficiency)
* Are pregnant or are planning to become pregnant during the study
18 Years
ALL
No
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Steven Clinton
Principal Investigator
Principal Investigators
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Steven Clinton, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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References
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Hill EB, Pashkova A, Grainger EM, Roberts KM, Chitchumroonchokchai C, Braun AC, Ralston RA, Riedl KM, Spees CK, Clinton SK. Targeted Urinary Profiling as a Biomarker of Dietary Flavonoid Intake from Fruits and Vegetables and its Relationship to the Timing of Dietary Assessment. Curr Dev Nutr. 2025 Jul 31;9(9):107520. doi: 10.1016/j.cdnut.2025.107520. eCollection 2025 Sep.
Braun AC, Portner J, Grainger EM, Clinton SK, Xu M, Darragh A, Pratt KJ, Weaver LL, Spees CK. Impact of Dietitian-Delivered Motivational Interviewing Within a Food is Medicine Intervention Targeting Adults Living With and Beyond Cancer. J Cancer Educ. 2025 Aug;40(4):609-615. doi: 10.1007/s13187-024-02552-4. Epub 2024 Dec 21.
Related Links
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The Jamesline
Other Identifiers
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NCI-2017-01031
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-17012
Identifier Type: -
Identifier Source: org_study_id