NExT (Nutrition and Exercise Cancer Survivor Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Adherence to either the DGA/AICR group or the DGA/AICR + Beef group
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a body mass index (BMI) >= 25 kg/m^2
- •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
排除标准
- •Are cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program
- •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
研究组 & 干预措施
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).
干预措施: Dietary Intervention (Other)
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).
干预措施: Exercise Intervention (Behavioral)
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).
干预措施: Laboratory Biomarker Analysis (Other)
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).
干预措施: Nutritional Intervention (Dietary Supplement)
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).
干预措施: Questionnaire Administration (Other)
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.
干预措施: Laboratory Biomarker Analysis (Other)
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.
干预措施: Dietary Intervention (Other)
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.
干预措施: Exercise Intervention (Behavioral)
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.
干预措施: Nutritional Intervention (Dietary Supplement)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Adherence to either the DGA/AICR group or the DGA/AICR + Beef group
时间窗: Up to 12 months
Participants will keep both 7 day diet records periodically through out the study as well as a daily log of beef consumption
Change in body composition
时间窗: Up to 12 months
Change in body composition will be assessed by dual X-ray absorptiometry (iDXA)
Change in blood pressure
时间窗: Baseline up to 12 months
Trained personnel will use a sphygomanometer to assess blood pressure
Change in body mass index (BMI)
时间窗: Baseline up to 12 months
Weight and height will be combined to report BMI in kg/m\^2.
Change in dietary carotenoid intake
时间窗: Baseline up to 12 months
Assessed by Raman spectroscopy
Change in blood carotenoids
时间窗: Up to 12 months
Assessed by High Pressure Liquid Chromatography
Change in physical performance assessed by timed performance-related mobility tasks
时间窗: Baseline up to 12 months
Physical performance will be measured using the 40 M walk test
Change in physical performance
时间窗: Up to 12 months
Assessed by a standardized stair climb test
Dietary intake patterns
时间窗: Up to 6 months
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.
Adherence to classes
时间窗: Up to 12 months
Descriptive statistics will be generated using attendance forms
Change in fasting glucose
时间窗: Up to 12 months
A fasting blood sample will be used to measure glucose at three time points
Change in lipoprotein profiles
时间窗: Up to 12 months
A fasting blood sample will be used to assess serum lipoprotein profile
Daily physical activity (steps per day)
时间窗: up to 12 months
Each participants daily FitBit data will be downloaded to a secure spreadsheet
次要结局
- Health related quality of life(Up to 12 months)
研究者
Steven Clinton
Principal Investigator
Ohio State University Comprehensive Cancer Center