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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Behavioral study, Biomarker/Laboratory analysis, Prevention Active 50 and over NCI VU-VICC-GI-0810 VICCGI0810, VU-VICC-061020, NCT00653484

Trial Description

Purpose:

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:

Eligibility criteria include the following:

• At least 50 years old
• No eating disorders
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

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 Contact Information

Trial Lead Organizations

Vanderbilt-Ingram Cancer Center

Charles Matthews, PhD, Principal investigator		Ph: 800-811-8480

U.S.A.
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;
	Vanderbilt-Ingram Cancer Center - Cool Springs
		Charles Matthews, PhD	Ph:  615-322-4967
	Vanderbilt-Ingram Cancer Center at Franklin
		Charles Matthews, PhD	Ph:  615-591-9890

Registry Information
Official Title		Energy Balance Interventions for Colorectal Cancer Prevention
Trial Start Date		2008-06-22 (estimated)
Trial Completion Date		2013-06-01 (estimated)
Registered in ClinicalTrials.gov		NCT00653484
Date Submitted to PDQ		2008-03-24
Information Last Verified		2008-10-01
NCI Grant/Contract Number		CA68485