Program to Reduce Incontinence by Diet and Exercise (PRIDE) - Full Text View

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00091988

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

MedlinePlus related topics: Exercise and Physical Fitness Urinary Incontinence Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Program to Reduce Incontinence by Diet and Exercise

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
Estimated Study Completion Date:	November 2007

Arms	Assigned Interventions
Lifestyle & Behavioral Change Program: Experimental	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.

Arms

Assigned Interventions

Lifestyle & Behavioral Change Program: Experimental

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

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

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

PRIDE Public Website This link exits the ClinicalTrials.gov site

Responsible Party:	University of California, San Francisco ( Deborah Grady, MD, MPH )
Study ID Numbers:	1 UO1 DK67860
Study First Received:	September 21, 2004
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00091988
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

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Urologic Diseases

Urination Disorders
Weight Loss
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 14, 2009