NCT03489213

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

NExT (Nutrition and Exercise Cancer Survivor Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer Survivor
• Overweight

Interventions

Type	Name	Description
OTHER	Dietary 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.
BEHAVIORAL	Exercise Intervention	Participants will wear a FitBit every day and monitor daily physical activity.
OTHER	Laboratory Biomarker Analysis	Correlative studies
DIETARY_SUPPLEMENT	Nutritional 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.
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2017-04-25
• Primary completion: 2018-06-01
• Completion: 2019-06-01
• First posted: 2018-04-05
• Last updated: 2019-08-30

Locations

1 site across 1 country: United States