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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00470119 |
RATIONALE: A low-calorie diet and/or exercise program may help lower an overweight or obese postmenopausal woman's risk of developing breast cancer. It is not yet known whether a low-calorie diet and/or exercise program are more effective than no diet or exercise program in lowering an overweight or obese postmenopausal woman's risk of developing breast cancer.
PURPOSE: This randomized clinical trial is studying the effect of a low-calorie diet and/or exercise program on risk factors for developing breast cancer compared with no diet or exercise program in overweight or obese postmenopausal women.
Condition | Intervention |
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Breast Cancer Obesity Weight Changes |
Behavioral: behavioral dietary intervention Behavioral: exercise intervention Dietary Supplement: dietary intervention Other: educational intervention Other: laboratory biomarker analysis Other: preventative dietary intervention Procedure: complementary or alternative medicine procedure Procedure: evaluation of cancer risk factors Procedure: immunoscintigraphy Procedure: quality-of-life assessment Procedure: radiomammography |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
Official Title: | Exercise Diet and Sex Hormones in Postmenopausal Women (NEW) |
Estimated Enrollment: | 503 |
Study Start Date: | December 2004 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized study. Participants are stratified according to body mass index (< 27 vs ≥ 27).
Participants are randomized to 1 of 4 intervention arms.
Participants receive general information about diet and behavior strategies such as self-monitoring, goal-setting, stimulus-control, problem-solving, and relapse-prevention training. Participants learn to set a calorie goal and a fat gram goal and how to achieve the goal calorie reduction. Meetings are held weekly during the first 6 months of the diet program but taper off over the course of the study.
Participants complete questionnaires at baseline and at 6 and 12 months for assessment of diet and exercise.
Quality of life (QOL) is measured at baseline and at 6 and 12 months using the Medical Outcomes Study 36-Item Short Form and the Impact of Weight on QOL questionnaire. Information on health habits, medical history, family history of breast cancer, and reproductive and menstrual history is also collected.
PROJECTED ACCRUAL: A total of 503 participants (135 per intervention arm and 98 in control arm) will be accrued for this study.
Ages Eligible for Study: | 50 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At increased risk for developing breast cancer due to any of the following lifestyle risk factors:
PATIENT CHARACTERISTICS:
No diabetes mellitus
No contraindications for treadmill testing or entry into a training program, including any of the following:
Normal exercise treadmill testing (ETT)
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Contact Person 206-667-6444 new@fhcrc.org |
Principal Investigator: | Anne McTiernan, MD, PhD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000544634, FHCRC-PHS-1960.00, FHCRC-1960 |
Study First Received: | May 3, 2007 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00470119 History of Changes |
Health Authority: | Unspecified |
breast cancer obesity weight changes |
Body Weight Signs and Symptoms Obesity Skin Diseases Body Weight Changes Nutrition Disorders |
Breast Neoplasms Overnutrition Overweight Hormones Breast Diseases |
Body Weight Signs and Symptoms Obesity Neoplasms Neoplasms by Site Skin Diseases |
Body Weight Changes Nutrition Disorders Breast Neoplasms Overweight Overnutrition Breast Diseases |