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

September 21, 2004
March 2, 2010
July 2004
Not Provided
  • 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 ]
  • Frequency of incontinent episodes
  • Predictors of improvement in urinary incontinence
Complete list of historical versions of study NCT00091988 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Reduction in Weight
  • Maintenance of Weight Loss
Not Provided
Not Provided
 
Program to Reduce Incontinence by Diet and Exercise (PRIDE)
Program to Reduce Incontinence by Diet and Exercise

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Urinary Incontinence
  • 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.
  • 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.
  • Experimental: Lifestyle & Behavioral Change Program
    Intervention: Behavioral: Lifestyle & Behavioral Change Program
  • Structured Education Program
    Intervention: Behavioral: Structured Education Program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
330
November 2007
Not Provided

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
Female
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00091988
UO1 DK67860 (completed)
Yes
Deborah Grady, MD, MPH, University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
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)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP