Nutrition and Exercise Trial: Improving Diet and Physical Activity Patterns in Overweight Cancer Survivors (NExT)

NExT (Nutrition and Exercise Cancer Survivor Trial)

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Cancer Survivor
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Questionnaire Administration; Other: Dietary Intervention; Behavioral: Exercise Intervention; Dietary supplement: Nutritional Intervention

Detailed Description

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
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; 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.; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Behavioral: Exercise Intervention; Participants will wear a FitBit every day and monitor daily physical activity.; 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.
Experimental: 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.	Other: Laboratory Biomarker Analysis; Correlative studies; Other: Questionnaire Administration; Ancillary studies; 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.; Other Names: Dietary Modification; intervention, dietary; Nutrition Intervention; Nutrition Interventions; Nutritional Interventions; Behavioral: Exercise Intervention; Participants will wear a FitBit every day and monitor daily physical activity.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 12 months
Change in body composition	Change in body composition will be assessed by dual X-ray absorptiometry (iDXA)	Up to 12 months
Change in blood pressure	Trained personnel will use a sphygomanometer to assess blood pressure	Baseline up to 12 months
Change in body mass index (BMI)	Weight and height will be combined to report BMI in kg/m^2.	Baseline up to 12 months
Change in dietary carotenoid intake	Assessed by Raman spectroscopy	Baseline up to 12 months
Change in blood carotenoids	Assessed by High Pressure Liquid Chromatography	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	Baseline up to 12 months
Change in physical performance	Assessed by a standardized stair climb test	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.	Up to 6 months
Adherence to classes	Descriptive statistics will be generated using attendance forms	Up to 12 months
Change in fasting glucose	A fasting blood sample will be used to measure glucose at three time points	Up to 12 months
Change in lipoprotein profiles	A fasting blood sample will be used to assess serum lipoprotein profile	Up to 12 months
Daily physical activity (steps per day)	Each participants daily FitBit data will be downloaded to a secure spreadsheet	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	Measured at all three time points using the Health Related Quality of Life (HR-QOL) questionnaire	Up to 12 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Steven Clinton, MD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 29, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: OSU-17012; NCI-2017-01031 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No