Energy Balance Interventions for Colorectal Cancer Prevention
3 other identifiers
interventional
40
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started Mar 2008
Longer than P75 for not_applicable colorectal-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedDecember 17, 2013
December 1, 2013
1.2 years
April 4, 2008
December 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical activity-energy expenditure
June 2010
Secondary Outcomes (3)
Physical activity-energy expenditure
June 2010
Dietary-energy intake (kcal/d) and quality
June 2010
Body weight and composition
June 2010
Study Arms (3)
Physical Activity Only
EXPERIMENTALPhysical Activity
Dietary Energy Restriction
EXPERIMENTALEnergy restriction
Physical Activity+Dietary Energy Restriction
EXPERIMENTALPhysical Activity ad Energy Restriction
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (3)
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, 37064, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Matthews, PhD
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Professor
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 7, 2008
Study Start
March 1, 2008
Primary Completion
May 1, 2009
Study Completion
June 1, 2013
Last Updated
December 17, 2013
Record last verified: 2013-12