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

NCT03489213 | Completed DMC

• 2 other identifiers: OSU-17012NCI-2017-01031
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivor; Overweight

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (1)

• Health related quality of life

  Up to 12 months

Study Arms (2)

Arm I (DGA/AICR)

ACTIVE COMPARATOR

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

Arm II (DGA/AICR plus Beef)

EXPERIMENTAL

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

Dietary Intervention OTHER

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

Arm I (DGA/AICR); Arm II (DGA/AICR plus Beef)

Exercise Intervention BEHAVIORAL

Participants will wear a FitBit every day and monitor daily physical activity.

Arm I (DGA/AICR); Arm II (DGA/AICR plus Beef)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (DGA/AICR); Arm II (DGA/AICR plus Beef)

Nutritional Intervention DIETARY_SUPPLEMENT

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.

Arm I (DGA/AICR); Arm II (DGA/AICR plus Beef)

Questionnaire Administration OTHER

Ancillary studies

Arm I (DGA/AICR); Arm II (DGA/AICR plus Beef)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Hill EB, Pashkova A, Grainger EM, Roberts KM, Chitchumroonchokchai C, Braun AC, Ralston RA, Riedl KM, Spees CK, Clinton SK. Targeted Urinary Profiling as a Biomarker of Dietary Flavonoid Intake from Fruits and Vegetables and its Relationship to the Timing of Dietary Assessment. Curr Dev Nutr. 2025 Jul 31;9(9):107520. doi: 10.1016/j.cdnut.2025.107520. eCollection 2025 Sep.

  PMID: 41080470 DERIVED

• Braun AC, Portner J, Grainger EM, Clinton SK, Xu M, Darragh A, Pratt KJ, Weaver LL, Spees CK. Impact of Dietitian-Delivered Motivational Interviewing Within a Food is Medicine Intervention Targeting Adults Living With and Beyond Cancer. J Cancer Educ. 2025 Aug;40(4):609-615. doi: 10.1007/s13187-024-02552-4. Epub 2024 Dec 21.

  PMID: 39708224 DERIVED

Related Links

• The Jamesline

MeSH Terms

Conditions

Overweight

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Steven Clinton, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: April 5, 2018
• Study Start: April 25, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: August 30, 2019

Record last verified: 2019-08

Locations

US (1)