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

Primary Purpose

Cancer Survivor, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary Intervention
Exercise Intervention
Laboratory Biomarker Analysis
Nutritional Intervention
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (DGA/AICR)

Arm II (DGA/AICR plus Beef)

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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
Change in body composition
Change in body composition will be assessed by dual X-ray absorptiometry (iDXA)
Change in blood pressure
Trained personnel will use a sphygomanometer to assess blood pressure
Change in body mass index (BMI)
Weight and height will be combined to report BMI in kg/m^2.
Change in dietary carotenoid intake
Assessed by Raman spectroscopy
Change in blood carotenoids
Assessed by High Pressure Liquid Chromatography
Change in physical performance assessed by timed performance-related mobility tasks
Physical performance will be measured using the 40 M walk test
Change in physical performance
Assessed by a standardized stair climb test
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.
Adherence to classes
Descriptive statistics will be generated using attendance forms
Change in fasting glucose
A fasting blood sample will be used to measure glucose at three time points
Change in lipoprotein profiles
A fasting blood sample will be used to assess serum lipoprotein profile
Daily physical activity (steps per day)
Each participants daily FitBit data will be downloaded to a secure spreadsheet

Secondary Outcome Measures

Health related quality of life
Measured at all three time points using the Health Related Quality of Life (HR-QOL) questionnaire

Full Information

First Posted
February 9, 2018
Last Updated
August 29, 2019
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03489213
Brief Title
Nutrition and Exercise Trial: Improving Diet and Physical Activity Patterns in Overweight Cancer Survivors
Acronym
NExT
Official Title
NExT (Nutrition and Exercise Cancer Survivor Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Overweight

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (DGA/AICR)
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Arm II (DGA/AICR plus Beef)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Other Intervention Name(s)
Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Participants will wear a FitBit every day and monitor daily physical activity.
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Adherence to either the DGA/AICR group or the DGA/AICR + Beef group
Description
Participants will keep both 7 day diet records periodically through out the study as well as a daily log of beef consumption
Time Frame
Up to 12 months
Title
Change in body composition
Description
Change in body composition will be assessed by dual X-ray absorptiometry (iDXA)
Time Frame
Up to 12 months
Title
Change in blood pressure
Description
Trained personnel will use a sphygomanometer to assess blood pressure
Time Frame
Baseline up to 12 months
Title
Change in body mass index (BMI)
Description
Weight and height will be combined to report BMI in kg/m^2.
Time Frame
Baseline up to 12 months
Title
Change in dietary carotenoid intake
Description
Assessed by Raman spectroscopy
Time Frame
Baseline up to 12 months
Title
Change in blood carotenoids
Description
Assessed by High Pressure Liquid Chromatography
Time Frame
Up to 12 months
Title
Change in physical performance assessed by timed performance-related mobility tasks
Description
Physical performance will be measured using the 40 M walk test
Time Frame
Baseline up to 12 months
Title
Change in physical performance
Description
Assessed by a standardized stair climb test
Time Frame
Up to 12 months
Title
Dietary intake patterns
Description
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.
Time Frame
Up to 6 months
Title
Adherence to classes
Description
Descriptive statistics will be generated using attendance forms
Time Frame
Up to 12 months
Title
Change in fasting glucose
Description
A fasting blood sample will be used to measure glucose at three time points
Time Frame
Up to 12 months
Title
Change in lipoprotein profiles
Description
A fasting blood sample will be used to assess serum lipoprotein profile
Time Frame
Up to 12 months
Title
Daily physical activity (steps per day)
Description
Each participants daily FitBit data will be downloaded to a secure spreadsheet
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
Measured at all three time points using the Health Related Quality of Life (HR-QOL) questionnaire
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Clinton, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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