Program to Reduce Incontinence by Diet and Exercise (PRIDE)
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| ClinicalTrials.gov Identifier: NCT00091988 |
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Recruitment Status :
Completed
First Posted : September 22, 2004
Last Update Posted : April 16, 2020
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Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Brief Summary:
PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Urinary Incontinence | Behavioral: Lifestyle & Behavioral Change Program Behavioral: Structured Education Program | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 338 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Program to Reduce Incontinence by Diet and Exercise |
| Actual Study Start Date : | July 2004 |
| Actual Primary Completion Date : | November 2007 |
| Actual Study Completion Date : | November 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Urinary Incontinence
| Arm | Intervention/treatment |
|---|---|
| Experimental: Lifestyle & Behavioral Change Program |
Behavioral: Lifestyle & Behavioral Change Program
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. |
| Active Comparator: Structured Education Program |
Behavioral: Structured Education Program
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. |
Primary Outcome Measures :
- Change in the number of incontinent episodes [ Time Frame: 6 months ]Change in the number of incontinence episodes reported in a 7-day voiding diary from baseline to 6 months
Secondary Outcome Measures :
- Change in body weight at 6 months [ Time Frame: 6 months ]Change from baseline in body weight measured in kg
- Change in body weight at 12 months [ Time Frame: 12 months ]Change from baseline in body weight measured in kg
- Change in body weight at 18 months [ Time Frame: 18 months ]Change from baseline in body weight measured in kg
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| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00091988
Locations
| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35205 | |
| United States, Arkansas | |
| University of Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| University of California at San Francisco | |
| San Francisco, California, United States, 94110 | |
| United States, Rhode Island | |
| Miriam Hospital/Brown University | |
| Providence, Rhode Island, United States, 02903 | |
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Francisco
Investigators
| Principal Investigator: | Deborah Grady, MD, PhD | UCSF Coordinating Center | |
| Principal Investigator: | Leslee Subak, MD | UCSF Coordinating Center | |
| Study Director: | John Kusek, PhD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | |
| Study Director: | Lee Nyberg, PhD | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00091988 |
| Other Study ID Numbers: |
U01DK067860 ( U.S. NIH Grant/Contract ) U01DK067860 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 22, 2004 Key Record Dates |
| Last Update Posted: | April 16, 2020 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/pride/?query=pride |
| URL: | https://repository.niddk.nih.gov/studies/pride/?query=pride |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
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Urinary Incontinence Weight Loss Obesity Motivation |
Additional relevant MeSH terms:
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Urinary Incontinence Enuresis Urination Disorders Urologic Diseases Lower Urinary Tract Symptoms |
Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders |