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

Overweight Clinical Trial

— NExT  

Official title:

NExT (Nutrition and Exercise Cancer Survivor Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03489213
• Other study ID #: OSU-17012
• Secondary ID: NCI-2017-01031
• Status: Completed
• Phase: N/A
• Start date: April 25, 2017
• Est. completion date: June 1, 2019

Study information

• Verified date: August 2019
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor
• Overweight

Intervention

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

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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