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Alternate Title Randomized Pilot Study of Energy Balance Interventions Comprising a Dietary Energy Restriction and/or Physical Activity Intervention Versus No Intervention in Healthy, Overweight, Obese, or Sedentary Participants At Increased Risk for Developing Colorectal Cancer
Trial Description Calories and physical exercise may affect the risk of developing cancer. It is not yet known whether a low-calorie diet and/or physical activity program is effective in preventing cancer in participants at increased risk of developing colorectal cancer. This randomized clinical trial is studying diet and physical activity in healthy overweight, obese, or inactive participants at risk of developing colorectal cancer. Eligibility criteria include the following:
Final eligibility for a clinical trial is determined by the health professionals conducting the trial. Participants will visit Vanderbilt University General Clinical Research Center for body composition measurements, diet evaluations, physical activity, and other testing. Within 2 weeks, they will be randomly assigned (have an equal chance of being placed) to one of four groups. Participants in group one will undergo a 30- to 60-minute counseling session to set goals and develop a plan for a home-based activity and exercise program. They will also receive pedometers to track their activity for 7 days at the beginning of the study and at 12 weeks. Participants will keep a log of daily exercise and pedometer steps. Participants in group two will receive a personalized low-calorie diet for 12 weeks. All meals will be prepared by Vanderbilt University General Clinical Research Center. Participants will receive a multivitamin once a day. They will meet with a dietitian once a week to receive individual instruction, counseling, and assessment. They will also keep food records, return uneaten food, and provide urine samples. Participants in group three will receive an individualized 12-week low calorie diet and physical-activity program as in groups one and two. Participants in group four will be evaluated periodically. After 12 weeks, participants' body composition, fitness, diet, and activity measurements will be repeated. Participants will undergo blood and urine sample collection at the beginning of the study and at 12 weeks for laboratory studies. They will also will fill out a physical activity questionnaire at the beginning of the study and at 12 weeks. Important: For more details about this trial, refer to the Health Professional version of the trial summary. If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site. Trial Lead Organizations Vanderbilt-Ingram Cancer Center
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