Energy Balance Interventions for Colorectal Cancer Prevention

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Maciej Buchowski, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00653484
First received: April 4, 2008
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

RATIONALE: 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.

PURPOSE: This randomized clinical trial is studying diet and physical activity in healthy overweight, obese, or inactive participants at risk of developing colorectal cancer.


Condition Intervention
Colorectal Cancer
Obesity
Behavioral: Physical Activity
Behavioral: Energy Restriction
Behavioral: Physical Activity and Energy Restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Energy Balance Interventions for Colorectal Cancer Prevention

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Physical activity-energy expenditure [ Time Frame: June 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical activity-energy expenditure [ Time Frame: June 2010 ] [ Designated as safety issue: No ]
  • Dietary-energy intake (kcal/d) and quality [ Time Frame: June 2010 ] [ Designated as safety issue: No ]
  • Body weight and composition [ Time Frame: June 2010 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2008
Study Completion Date: June 2013
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical Activity Only
Physical Activity
Behavioral: Physical Activity
Experimental: Dietary Energy Restriction
Energy restriction
Behavioral: Energy Restriction
Experimental: Physical Activity+Dietary Energy Restriction
Physical Activity ad Energy Restriction
Behavioral: Physical Activity and Energy Restriction

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

DISEASE CHARACTERISTICS:

  • Healthy participants at increased risk for developing colorectal cancer due to any of the following risk factors:

    • Excess weight or obesity

      • Body mass index 25-40 kg/m²
    • Not currently exercising on a regular basis (< 1,000 kcal/week)
  • Must be free of significant eating disorders (i.e., purging, extended fasting, or use of laxatives)

PATIENT CHARACTERISTICS:

  • Females must be postmenopausal, defined by the absence of menstrual periods in the past 12 months
  • No heart disease or orthopedic impairments that would limit exercise or may be worsened by exercise
  • No major chronic diseases (e.g., liver, kidney, diabetes, or adrenal ailments) that would influence metabolism
  • No cancer diagnoses within the past 5 years, except skin cancer

Exclusion Criteria:

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653484

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Charles Matthews, PhD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Maciej Buchowski, Research Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00653484     History of Changes
Other Study ID Numbers: CDR0000592809, VU-VICC-GI-0810, VU-VICC-061020
Study First Received: April 4, 2008
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
colon cancer
rectal cancer
obesity

Additional relevant MeSH terms:
Colorectal Neoplasms
Obesity
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 20, 2014