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Program to Reduce Incontinence by Diet and Exercise (PRIDE)

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle & Behavioral Change Program
Structured Education Program
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Urinary Incontinence, Weight Loss, Obesity, Motivation

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Alabama
  • University of Arkansas
  • University of California at San Francisco
  • Miriam Hospital/Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle & Behavioral Change Program

Structured Education Program

Arm Description

Outcomes

Primary Outcome Measures

Change in the number of incontinent episodes
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
Change from baseline in body weight measured in kg
Change in body weight at 12 months
Change from baseline in body weight measured in kg
Change in body weight at 18 months
Change from baseline in body weight measured in kg

Full Information

First Posted
September 21, 2004
Last Updated
April 14, 2020
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00091988
Brief Title
Program to Reduce Incontinence by Diet and Exercise
Acronym
PRIDE
Official Title
Program to Reduce Incontinence by Diet and Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 2004 (Actual)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Urinary Incontinence, Weight Loss, Obesity, Motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
338 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle & Behavioral Change Program
Arm Type
Experimental
Arm Title
Structured Education Program
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle & Behavioral Change Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Structured Education Program
Intervention Description
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 Measure Information:
Title
Change in the number of incontinent episodes
Description
Change in the number of incontinence episodes reported in a 7-day voiding diary from baseline to 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in body weight at 6 months
Description
Change from baseline in body weight measured in kg
Time Frame
6 months
Title
Change in body weight at 12 months
Description
Change from baseline in body weight measured in kg
Time Frame
12 months
Title
Change in body weight at 18 months
Description
Change from baseline in body weight measured in kg
Time Frame
18 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Grady, MD, PhD
Organizational Affiliation
UCSF Coordinating Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leslee Subak, MD
Organizational Affiliation
UCSF Coordinating Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Kusek, PhD
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lee Nyberg, PhD
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
University of Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Miriam Hospital/Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available at the NIDDK Central Repository: https://repository.niddk.nih.gov/studies/pride/?query=pride
IPD Sharing URL
https://repository.niddk.nih.gov/studies/pride/?query=pride
Citations:
PubMed Identifier
22453270
Citation
Myers DL, Sung VW, Richter HE, Creasman J, Subak LL. Prolapse symptoms in overweight and obese women before and after weight loss. Female Pelvic Med Reconstr Surg. 2012 Jan-Feb;18(1):55-9. doi: 10.1097/SPV.0b013e31824171f9.
Results Reference
derived
PubMed Identifier
22161726
Citation
Pinto AM, Subak LL, Nakagawa S, Vittinghoff E, Wing RR, Kusek JW, Herman WH, West DS, Kuppermann M. The effect of weight loss on changes in health-related quality of life among overweight and obese women with urinary incontinence. Qual Life Res. 2012 Dec;21(10):1685-94. doi: 10.1007/s11136-011-0086-2. Epub 2011 Dec 10.
Results Reference
derived
PubMed Identifier
21461953
Citation
Pinto AM, Kuppermann M, Nakagawa S, Vittinghoff E, Wing RR, Kusek JW, Herman WH, Subak LL. Comparison and correlates of three preference-based health-related quality-of-life measures among overweight and obese women with urinary incontinence. Qual Life Res. 2011 Dec;20(10):1655-62. doi: 10.1007/s11136-011-9896-5. Epub 2011 Apr 3.
Results Reference
derived
PubMed Identifier
20680012
Citation
West DS, Gorin AA, Subak LL, Foster G, Bragg C, Hecht J, Schembri M, Wing RR; Program to Reduce Incontinence by Diet and Exercise (PRIDE) Research Group. A motivation-focused weight loss maintenance program is an effective alternative to a skill-based approach. Int J Obes (Lond). 2011 Feb;35(2):259-69. doi: 10.1038/ijo.2010.138. Epub 2010 Aug 3.
Results Reference
derived
PubMed Identifier
20664387
Citation
Wing RR, Creasman JM, West DS, Richter HE, Myers D, Burgio KL, Franklin F, Gorin AA, Vittinghoff E, Macer J, Kusek JW, Subak LL; Program to Reduce Incontinence by Diet and Exercise (PRIDE). Improving urinary incontinence in overweight and obese women through modest weight loss. Obstet Gynecol. 2010 Aug;116(2 Pt 1):284-292. doi: 10.1097/AOG.0b013e3181e8fb60.
Results Reference
derived
PubMed Identifier
20643425
Citation
Wing RR, West DS, Grady D, Creasman JM, Richter HE, Myers D, Burgio KL, Franklin F, Gorin AA, Vittinghoff E, Macer J, Kusek JW, Subak LL; Program to Reduce Incontinence by Diet and Exercise Group. Effect of weight loss on urinary incontinence in overweight and obese women: results at 12 and 18 months. J Urol. 2010 Sep;184(3):1005-10. doi: 10.1016/j.juro.2010.05.031.
Results Reference
derived
PubMed Identifier
20625026
Citation
Huang AJ, Subak LL, Wing R, West DS, Hernandez AL, Macer J, Grady D; Program to Reduce Incontinence by Diet and Exercise Investigators. An intensive behavioral weight loss intervention and hot flushes in women. Arch Intern Med. 2010 Jul 12;170(13):1161-7. doi: 10.1001/archinternmed.2010.162. Erratum In: Arch Intern Med. 2010 Sep 27;170(17):1601.
Results Reference
derived
PubMed Identifier
19179316
Citation
Subak LL, Wing R, West DS, Franklin F, Vittinghoff E, Creasman JM, Richter HE, Myers D, Burgio KL, Gorin AA, Macer J, Kusek JW, Grady D; PRIDE Investigators. Weight loss to treat urinary incontinence in overweight and obese women. N Engl J Med. 2009 Jan 29;360(5):481-90. doi: 10.1056/NEJMoa0806375.
Results Reference
derived

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Program to Reduce Incontinence by Diet and Exercise

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