Program to Reduce Incontinence by Diet and Exercise

Study Overview
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Brief Summary
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PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.

Detailed Description
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Three hundred and thirty overweight and obese women with urinary incontinence, 165 from each of two Clinical Centers, will be randomized to either a 6-month intensive behavioral weight control program or to usual care (no weight reduction intervention) and followed for 18 months. Efficacy of weight reduction as a treatment for urinary incontinence will be examined at 6 months following the intensive weight control program, and the sustained impact of the intervention will be examined at 18 months. To increase the maintenance of weight reduction and facilitate evaluation of the enduring impact of weight loss on urinary incontinence, we propose to study a motivation-based weight maintenance program. At the end of the intensive weight control program, women randomized to the weight loss program will be randomized to either a 12-month skill-based maintenance intervention or to a motivation-based maintenance intervention. The maintenance interventions maximize the potential for sustained weight loss and will allow us to determine if long-term weight reduction will produce continued improvement in urinary incontinence.

Official Title
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Program to Reduce Incontinence by Diet and Exercise

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Behavioral: Lifestyle & Behavioral Change Program
* Behavioral: Structured Education Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle & Behavioral Change Program<br> | Behavioral: Lifestyle & Behavioral Change Program<br>* Participants in the weight loss arm will receive an intensive group-based behavioral weight loss program. In the first six months of the intervention, all participants in the weight loss arm will be given skill-based diet and exercise prescriptions for weight loss and will be taught specific cognitive and behavioral skills to assist in the modification of their eating and exercise habits. Participants will meet weekly for 6 months in group sessions led by a nutritionist, exercise physiologist, or behaviorist and will follow a structured protocol. This intervention strategy is modeled on interventions that have been successful in other overweight populations and is similar to the programs implemented in our ongoing studies, such as Look AHEAD. With this intervention, women are expected to lose on average of 7-9% of their initial body weight.<br>|
| Active Comparator: Structured Education Program<br> | Behavioral: Structured Education Program<br>* Women randomized to the Structured Education Program will be invited to participate in hour long group educational sessions at months 1, 2, 3, and 4. At months 6, 9 and 15, the groups will meet again for group support sessions. The content of these education and support sessions will include information about weight loss, physical activity, healthy eating habits and general health promotion. The educational sessions will be delivered primarily in a group format, with individual make up sessions provided for participants who miss group sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the number of incontinent episodes | Change in the number of incontinence episodes reported in a 7-day voiding diary from baseline to 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight at 6 months | Change from baseline in body weight measured in kg | 6 months | 
| Change in body weight at 12 months | Change from baseline in body weight measured in kg | 12 months | 
| Change in body weight at 18 months | Change from baseline in body weight measured in kg | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Weight Loss, Obesity, Motivation