Program to Reduce Incontinence by Diet and Exercise (PRIDE)

April 14, 2020 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
PRIDE will evaluate the impact of weight loss on urinary incontinence in a randomized, controlled trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas
    • California
      • San Francisco, California, United States, 94110
        • University of California at San Francisco
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Miriam Hospital/Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborators

University of California, San Francisco

Investigators

  • Study Director: John Kusek, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Principal Investigator: Deborah Grady, MD, PhD, UCSF Coordinating Center
  • Principal Investigator: Leslee Subak, MD, UCSF Coordinating Center
  • Study Director: Lee Nyberg, PhD, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 21, 2004

First Submitted That Met QC Criteria

September 21, 2004

First Posted (Estimate)

September 22, 2004

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01DK067860 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/pride/?query=pride

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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