Program to Reduce Incontinence by Diet and Exercise (PRIDE)
This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00091988
First received: September 21, 2004
Last updated: March 2, 2010
Last verified: March 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.
| Condition | Intervention |
|---|---|
|
Urinary Incontinence |
Behavioral: Lifestyle & Behavioral Change Program Behavioral: Structured Education Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Program to Reduce Incontinence by Diet and Exercise |
Resource links provided by NLM:
Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Outcome Measures:
- Frequency of incontinent episodes [ Time Frame: 7 day ] [ Designated as safety issue: No ]
- Predictors of improvement in urinary incontinence [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Reduction in Weight [ Time Frame: Baseline, 6 months, 12 months, and 18 months ] [ Designated as safety issue: No ]
- Maintenance of Weight Loss [ Time Frame: 12 months and 18 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 330 |
| Study Start Date: | July 2004 |
| Study Completion Date: | November 2007 |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
| 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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
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) |
More Information
Additional Information:
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Deborah Grady, MD, MPH, University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00091988 History of Changes |
| Other Study ID Numbers: | UO1 DK67860 (completed) |
| Study First Received: | September 21, 2004 |
| Last Updated: | March 2, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
Urinary Incontinence Weight Loss Obesity Motivation |
Additional relevant MeSH terms:
|
Urinary Incontinence Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013