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

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.

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