Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exercise Diet and Sex Hormones in Postmenopausal Women (NEW)
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Willing to sign a consent form.
* BMI during screening ≥25 kg/m2 (eligibility for weight loss support group)
* Participants must not have had any surgical procedures influencing weight regulation to include, but not limited to, gastric bypass, other bariatric surgeries, resection of small or large intestine leading to malabsorption, gastric resection for ulcers or cancer, and esophageal resection
* Intention to follow recommended program and complete outcome assessments and requested self-monitoring.
* Obtain a physician's clearance form
B: Inclusion Criteria:

* 18-65 years of age.
* Body mass index (BMI) between 25.0-49.9 kg/m2.
* Subject consumes at least 280 calories per day from caloric beverages.

Exclusion Criteria:

* Report losing \>5% of current body weight in the previous 6 months.
* Report participating in a research project involving weight loss or physical activity in the previous 6 months, as these proximal experiences may impact the results of this study. Additionally, report current participating in any other research studies whose results could be compromised by or in which participation could compromise this research study. (Participation in a research study that would not affect or be affected by this study is allowed.)
* Report pregnancy or lactation during the previous 6 months, or planned pregnancy in the next 6 months.
* Report taking medication that could affect metabolism or change body weight (e.g., synthroid).
* Report hospitalization for psychiatric problems during the prior year.
* Report major psychiatric diagnoses and organic brain syndromes.
* Report heart problems, chest pain, cancer within the last 5 years
* Being treated by a therapist for psychological issues or problems with psychotropic medications.
* Report behaviors that indicate probable alcohol dependence as assessed by the Rapid Alcohol Problems Screen (RAPS4-QF) (Cherpitel CJ, 2002).
* Unwilling to change intake of beverages during the study period.
* Plan to move from the area during the study period, and/or unable to attend monthly group meetings.
* Report not having adequate transportation to the study center that would allow transport of study supplies back to the subject's home.
* Report not being able to attend group meetings on Monday or Tuesday evenings.
C: Men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.
D: DISEASE CHARACTERISTICS:

* At increased risk for developing breast cancer due to any of the following lifestyle risk factors:

  * Lack of physical activity
  * Excess weight
  * Obesity
  * Weight gain over lifetime
* Body mass index \> 25.0
* Physically able to undertake a moderate exercise or calorie reduction program
* No history of invasive or in situ breast cancer

PATIENT CHARACTERISTICS:

* Postmenopausal, defined by the absence of periods for the past 12 months
* Able to attend study clinic visits and classes, and undergo study measurements
* Able to fill out questionnaires and logs in English
* No moderate to high alcohol intake (more than 2 drinks per day)
* No concurrent smoking
* No invasive cancer within the past 10 years except simple basal cell or squamous cell carcinoma
* No diabetes mellitus

  * Fasting blood sugar \< 126 mg/dL (on 2 occasions)
* Hematocrit 32-48%
* WBC 3,000-15,000/mm³
* Potassium 3.5-5.0 mEq/L
* Creatinine ≤ 2.0 mg/dL
* No abnormalities on screening physical that contraindicate study participation
* No contraindications for treadmill testing or entry into a training program, including any of the following:

  * Myocardial infarction within the past 6 months
  * Pulmonary edema
  * Myocarditis
  * Pericarditis
  * Unstable angina
  * Pulmonary embolism or deep vein thrombosis
  * Uncontrolled hypertension (i.e., blood pressure \> 200/100 mm Hg)
  * Orthostatic hypotension
  * Moderate-to-severe aortic stenosis
  * Uncontrolled arrhythmia
  * Uncontrolled congestive heart failure
  * Third-degree heart block
  * Left bundle branch block
  * Thrombophlebitis
  * ST depression \> 3 mm at rest
  * History of cardiac arrest or stroke
* Normal exercise treadmill testing (ETT)

  * Negative thallium or echo ETT required for patients with abnormal ETT (defined as ≥ 1.5 mm ST depression in \> 1 lead within 1-minute recovery OR ≥ 1.1 mm ST depression in \> 1 lead after 1-minute recovery OR reading of positive test by study doctor)
* No drug abuse
* No significant mental illness

PRIOR CONCURRENT THERAPY:

* More than 6 months since prior and no concurrent menopausal hormone replacement therapy of any type, including vaginal route
* No concurrent participation in any other organized weight loss or exercise program
* No concurrent appetite suppressant medication
* No concurrent medications (e.g., weight-loss medications) likely to interfere with adherence to interventions or study outcomes

Answer: D