Program to Reduce Incontinence by Diet and Exercise

NCT00091988 | Completed DMC

• 1 other identifier: U01DK067860
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Urinary Incontinence

Keywords

Urinary Incontinence; Weight Loss; Obesity; Motivation

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (3)

• Change in body weight at 6 months

  6 months

• Change in body weight at 12 months

  12 months

• Change in body weight at 18 months

  18 months

Study Arms (2)

Lifestyle & Behavioral Change Program

EXPERIMENTAL

Behavioral: Lifestyle & Behavioral Change Program

Structured Education Program

ACTIVE COMPARATOR

Behavioral: Structured Education Program

Interventions

Lifestyle & Behavioral Change Program BEHAVIORAL

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.

Lifestyle & Behavioral Change Program

Structured Education Program BEHAVIORAL

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.

Structured Education Program

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• University of California, San Francisco: collaborator

Study Sites (4)

University of Alabama

Birmingham, Alabama, 35205, United States

Location

University of Arkansas

Little Rock, Arkansas, 72205, United States

Location

University of California at San Francisco

San Francisco, California, 94110, United States

Location

Miriam Hospital/Brown University

Providence, Rhode Island, 02903, United States

Location

Related Publications (8)

• 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.

  PMID: 22453270 DERIVED

• 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.

  PMID: 22161726 DERIVED

• 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.

  PMID: 21461953 DERIVED

• 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.

  PMID: 20680012 DERIVED

• 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.

  PMID: 20664387 DERIVED

• 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.

  PMID: 20643425 DERIVED

• 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.

  PMID: 20625026 DERIVED

• 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.

  PMID: 19179316 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Deborah Grady, MD, PhD

  UCSF Coordinating Center

  PRINCIPAL INVESTIGATOR

• Leslee Subak, MD

  UCSF Coordinating Center

  PRINCIPAL INVESTIGATOR

• 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)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2004
• First Posted: September 22, 2004
• Study Start: July 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)