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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03489213
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Survivor Overweight Other: Dietary Intervention Behavioral: Exercise Intervention Other: Laboratory Biomarker Analysis Dietary Supplement: Nutritional Intervention Other: Questionnaire Administration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: NExT (Nutrition and Exercise Cancer Survivor Trial)
Actual Study Start Date : April 25, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


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: 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.

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

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: 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.

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




Primary Outcome Measures :
  1. Adherence to either the DGA/AICR group or the DGA/AICR + Beef group [ Time Frame: 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

  2. Change in body composition [ Time Frame: Up to 12 months ]
    Change in body composition will be assessed by dual X-ray absorptiometry (iDXA)

  3. Change in blood pressure [ Time Frame: Baseline up to 12 months ]
    Trained personnel will use a sphygomanometer to assess blood pressure

  4. Change in body mass index (BMI) [ Time Frame: Baseline up to 12 months ]
    Weight and height will be combined to report BMI in kg/m^2.

  5. Change in dietary carotenoid intake [ Time Frame: Baseline up to 12 months ]
    Assessed by Raman spectroscopy

  6. Change in blood carotenoids [ Time Frame: Up to 12 months ]
    Assessed by High Pressure Liquid Chromatography

  7. Change in physical performance assessed by timed performance-related mobility tasks [ Time Frame: Baseline up to 12 months ]
    Physical performance will be measured using the 40 M walk test

  8. Change in physical performance [ Time Frame: Up to 12 months ]
    Assessed by a standardized stair climb test

  9. Dietary intake patterns [ Time Frame: 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.

  10. Adherence to classes [ Time Frame: Up to 12 months ]
    Descriptive statistics will be generated using attendance forms

  11. Change in fasting glucose [ Time Frame: Up to 12 months ]
    A fasting blood sample will be used to measure glucose at three time points

  12. Change in lipoprotein profiles [ Time Frame: Up to 12 months ]
    A fasting blood sample will be used to assess serum lipoprotein profile

  13. Daily physical activity (steps per day) [ Time Frame: up to 12 months ]
    Each participants daily FitBit data will be downloaded to a secure spreadsheet


Secondary Outcome Measures :
  1. Health related quality of life [ Time Frame: Up to 12 months ]
    Measured at all three time points using the Health Related Quality of Life (HR-QOL) questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489213


Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Steven Clinton, MD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03489213    
Other Study ID Numbers: OSU-17012
NCI-2017-01031 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms