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

The Ohio State University

Status: Completed

Conditions: Overweight; Cancer Survivor

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03489213

NCI-2017-01031 (Registry Identifier)

OSU-17012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Arm I (DGA/AICR)

Active Comparator group

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).

Treatment:

Behavioral: Exercise Intervention

Dietary Supplement: Nutritional Intervention

Other: Laboratory Biomarker Analysis

Other: Dietary Intervention

Other: Questionnaire Administration

Arm II (DGA/AICR plus Beef)

Experimental group

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.

Treatment:

Behavioral: Exercise Intervention

Dietary Supplement: Nutritional Intervention

Other: Laboratory Biomarker Analysis

Other: Dietary Intervention

Other: Questionnaire Administration