CompletedNCT03489213NExTUpdated Aug 30, 2019

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

An interventional study of Dietary Intervention and Exercise Intervention in Cancer Survivor and Overweight, sponsored by Ohio State University Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-30.

Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 82
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Cancer Survivor
Overweight

Browse trials for

Overweight 3,644

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 82 participants (actual)

Study arms

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 · Behavioral: Exercise Intervention · Other: Laboratory Biomarker Analysis · Dietary Supplement: Nutritional Intervention · Other: Questionnaire Administration
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 · Behavioral: Exercise Intervention · Other: Laboratory Biomarker Analysis · Dietary Supplement: Nutritional Intervention · Other: Questionnaire Administration

Interventions

OtherDietary 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.
Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions
BehavioralExercise Intervention
Participants will wear a FitBit every day and monitor daily physical activity.
OtherLaboratory Biomarker Analysis
Correlative studies
Dietary supplementNutritional 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.
OtherQuestionnaire Administration
Ancillary studies

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

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

References and documents

Registry details

Key details

Study ID: NCT03489213
Lead sponsor: Ohio State University Comprehensive Cancer Center
Responsible party: Steven Clinton (Principal Investigator, Ohio State University Comprehensive Cancer Center) — Principal investigator
First posted: Apr 5, 2018
Start date: Apr 25, 2017
Primary completion: Jun 1, 2018
Completion: Jun 1, 2019
Last update: Aug 30, 2019

Study contacts

Steven Clinton, MD

principal investigator · Ohio State University Comprehensive Cancer Center

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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