Please select the eligibility criteria that correspond to the clinical trial below.
Title: Program to Reduce Incontinence by Diet and Exercise
Brief Summary: PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.


Options:
A: Inclusion Criteria:

* Women aged 40 years or older who report urinary incontinence for \> 3 months prior to screening
* Self-report at least 7 urinary incontinence episodes per week on a screening 7-day voiding diary
* Self-report urgency-predominant, stress-predominant, or mixed-type incontinence on the screening voiding diary
* Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study period
* Capable of understanding study procedures and giving informed consent

Exclusion Criteria:

* Participation in a yoga class or other formal or organized yoga instruction in the past year
* Any prior yoga therapy directed specifically at improving urinary incontinence or pelvic floor dysfunction
* Current use of medical therapy or device (i.e. pessary) for incontinence or use within the previous month
* Currently pregnant, gave birth within the past 6 months, or planning pregnancy during the study period
* Current urinary tract infection or a history or 3 or more urinary tract infections in the preceding year
* Report history of neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, or a lumbosacral spine condition associated with neurological symptoms
* Unable to walk up a flight of stairs or at least 2 blocks on level ground without assistance
* Unable to get up from a supine to a standing position in 10 seconds or less and without assistance
* Severe obesity, defined as body mass index \> 35 kg/m2 on screening examination
* Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage
* Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation for any reason
* Report use of bladder botox, electrostimulation, bladder training, or pelvic floor exercise training (with certified practitioners) in the past 3 months
* Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months
* Report symptomatic pelvic organ prolapse
* Report history of vulvodynia, chronic pelvic pain, or pain when practicing pelvic floor exercises
* Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia
* Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study
B: Inclusion Criteria:

* aged ≥ 30 years and not institutionalized
* body mass index 25 to 50 kg/m2
* urinary incontinence symptoms for \> 3 months by self-report and record \> 10 incontinent episodes per week on a 7-day urinary diary
* able to complete a behavioral run-in consisting of self-monitoring of food and activity
* report having a primary health care provider
* able to understand and sign informed consent and complete baseline questionnaires
* agree to not initiate new treatment for incontinence or weight reduction, including behavioral, pharmacological or surgical therapies, for the duration of the study

Exclusion Criteria:

* current use, or use within the previous month of medical therapy for incontinence
* currently pregnant or gave birth in the previous 6 months
* current urinary tract infection (dipstick urinalysis positive for leukocyte esterase, nitrites or blood) or report having \> 4 urinary tract infections in the preceding year
* incontinence of neurologic or functional origin (by history)
* self-report of prior anti-incontinence or urethral surgery, pelvic cancer or pelvic irradiation
* self-report of significant medical conditions of the genitourinary tract (genitourinary fistula, interstitial cystitis, symptomatic pelvic organ prolapse)
* report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity, including type 2 diabetes requiring medical therapy that may cause hypoglycemia, chronic steroid use or uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \> 100 mm Hg); women with a history of coronary heart disease may participate with written approval from their primary care physician
* currently engaged in an active weight loss program and/or experienced a 10% or greater weight reduction in the past 3 months
* report being unable to walk 2 blocks (1/4 mile) without stopping
* report conditions that, in the judgment of the Clinical Center Principal Investigator, render potential participants unlikely to follow the protocol for 18 months, including illness likely to be terminal within 2 years, plans to move, substance abuse or other significant psychiatric problems, or dementia
* participating in another research study that involves investigational drugs or can potentially confound the results of PRIDE
C: Inclusion Criteria:

* Pre-pregnancy body mass index of 28 or more
* 18 years or more
* singleton live fetus at the routine ultrasound scan

Exclusion Criteria:

* high risk for preterm labor or diseases that could interfere with participation
D: Inclusion Criteria:

* Type 2 diabetes
* Overweight
* BMI of 25 kg/m2 or greater
* If on insulin, BMI of 27 kg/m2 or greater
* Blood pressure less than 160/100 mmHg
* HbA1c less or equal to 11%
* Triglycerides less than 600 mg/dl
* Willingness to participate

Exclusion Criteria:

* Unable or unwilling to give informed consent or communicate with local study staff.
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
* Hospitalization for depression in past six months.
* Self-report of alcohol or substance abuse within the past twelve months.
* Current consumption of more than 14 alcoholic drinks per week.
* Current acute treatment or rehabilitation program for these problems.
* Plans to relocate to an area not served by Look AHEAD or travel plans that do not permit full participation in the study.
* Lack of support from primary care health provider or family members.
* Failure to complete the two-week run-in for dietary intake and exercise.
* Weight loss exceeding 10 lbs. in past three months.
* Current use of medications for weight loss.
* Self reported inability to walk two blocks.
* History of bariatric surgery, small bowel resection, or extensive bowel resection.
* Chronic treatment with systemic corticosteroids.
* Another member of the household is a participant or staff member in Look AHEAD.
* Currently pregnant or nursing.
* Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured.
* HIV positive (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV.
* Active tuberculosis (self-report).
* Cardiovascular disease (heart attack or procedure within the past three months).
* Participation in a cardiac rehabilitation program within last three months.
* Stroke or history/treatment for transient ischemic attacks in the past three months.
* Pulmonary embolus in past six months.
* Unstable angina pectoris or angina pectoris at rest.
* A history of cardiac arrest.
* Complex ventricular arrhythmia at rest or with exercise (e.g., ventricular tachycardia).
* Uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more).
* New York Heart Association (NYHA) Class III or IV congestive heart failure.
* Acute myocarditis, pericarditis or hypertrophic myocardiopathy.
* Clinically significant aortic stenosis.
* Left bundle branch block or cardiac pacemaker unless evaluated and cleared for participation by a cardiologist.
* Cardiac defibrillator.
* Heart transplant.
* History of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair.
* Resting heart rate less than 45 beats per minute or greater than 100 beats per minute.
* Any abnormality during the maximum exercise stress test that indicates that it would be unsafe to participate in the Lifestyle Intervention.
* Angina pectoris.
* Significant ST segment depression at low levels of exercise. (ST segment is the flat, isoelectric section of the ECG between the end of the S wave (the J point) and the beginning of the T wave)
* Exercise induced ventricular arrhythmias.
* Abnormal hemodynamics, such as flat or decreasing systolic blood pressure with increasing workload.
* Those at moderate to high risk for cardiac complications during exercise.
* Those who are unable to self-regulate activity or understand the recommended activity level.
* Renal disease or dialysis.
* Chronic obstructive pulmonary disease that would limit ability to follow the protocol.
* Self-reported chronic hepatitis B or C or cirrhosis.
* Inflammatory bowel disease requiring treatment in past year.
* Cushing's syndrome.
* Acromegaly.
* Amputation of lower limbs as result of non-traumatic causes.
* Any major organ transplant.

Answer: B