PRIDE: Program to Reduce Incontinence by Diet & Exercise

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Urinary incontinence Is a commonproblem among women that causesdistress, diminished quality of life and dramatic limitations in daily functioning. Overweight womenare at significantly increased risk of urinary incontinence and over 65% of womenwith incontinence are overweight. Data from short-term, preliminary studies suggestthat weight reduction may significantly reduce incontinence episodes. Thus, weightless may present a promising new approach to urinary incontinence treatment,one likely to produce a cascadeof broader health improvements in addition to reductions in frequencyof urinary incontinence. Therefore, we propose to randomize 330 overweight and obese womenwith urinary incontinence (165 at each of two clinical centers) to a 6-month intensive behavioral weight control programor to usual care to determine the short-term effect of weight loss on frequency of incontinence and quality of life, to identify women most likely to benefit from weight loss and to beginto explore the urodynamicmechanisms underlying incontinence improvement following weight loss. To maximize enduring effects of weight loss on urinary incontinence, it will be necessary to produce sustained weight loss. However, weight maintenance remainsa challenge in the obesity field. Therefore, we propose to evaluate an innovative, theory-guided weight maintenance program that will focus on increasing motivation and commitment to behavior change efforts and comparethis with a more standard, skills-focused weight maintenance program.After completing the 6-month weight loss program, women in the weight loss arm will be randomizedto either a 12-month standard, skill-based maintenance programor to a motivationally-focused maintenance intervention. Outcomes will include weight loss, incontinence frequency and quality of life at 18 months. If effective in women with incontinence, the methods and strategies of this innovative motivationally-focused maintenance intervention can be examined in other obesepopulations. WIN- Weight Reduction for Incontinence Network- brings together a unique group of outstanding and experienced investigators with expertise in urinary incontinence, obesity treatment and multicenter collabora- tive clinical trials at three Institutions, The proposed study design will allow us to efficiently evaluate both a novel treatment for urinary incontinence and a promising approach to enhancement of weight maintenance, and therefore to make substantive contributions to severalclinical arenas critical to women's health. PERFORMANCE Sm=(S) (organization,cty, state) University of California. San Francisco, CA University of Arkansas KEY PERSONNEL See instructions.' Use conflnusfibnpages as needed to provide the required Information Inthe format shown below. Start with Principal Investigator. Ust ell other key personnel Inalphabetical order, last name first. Name Organization Role on Project Grady, Deborah, M.D. University of California, San Francisco Principal Investigator Subak, Leslee L, M.D.. University of California, San Francisco Co-PrincipalInvestigator Brown, Jeanette S., M.D. University of California, San Francisco Investigator Vittlnghoff. Eric, Ph.D. University of California, San Francisco Biostatistician West, Delia Smith. Ph.D. University of Arkansas Consultant or Disclosure Permission Statement APP'icable to SBIR/STTR Only. See instructions. Q YesDNo ¿0'd DdDHn dSDfl NOIZ 1W 82:¿T ¿00¿-92-Onb Principal inwaEtinatnr/Program Director(Last, first, middle): ^¿Grarly. Dfihnrah ft THROUGH DETAILED BUDGET FOR INTflAL BUDGET PERIOD DIRECT COS¿TS ONLY 7/1/2003 6/30/2004 PERSONNEL (Applicant organization only) TYPE ' DOLLAR AMOUNT REQUEST! (omitcents} DRT INST- ROLE ON APPT. EffQ N BASE SALARY FRINGE NAME PROJECT (months) PR DJ SALARY REQUESTED BENEFITS TOTALS Principal Deborah Grady, M.D. Investigator 12 5% * 171,900 8,595 1,461 10,056 Leslee Subak, M.D. C¿-pl p^tf* 12 ^S"WJh%^ . 140,492 'lS&Pe -Zrt-65 ¿-4&t^T.(3r~r2- Jeanette Brown Collaborator 12 3% * 171,900 4,298 731 5,029 J,ud,y M..acer Pro'ject Director 12 e>0% 82,398 41,199 7,004 48,203 EricVirtinghoff,Ph.D. Statitician 12 10% 108,395 10,839 2,385 13,224 TEA Data Programmer Data Pr¿9rammer 12 2!0% 55,000 11,000 2,420 13,420 TEA Project Assistant ProjectAssistant 12 ¿>0% - 39,595 19,798 4,356 24,154 ^ .u SUBTOTALS "actual salary exceedsthe cap 13*677 2*52? 1T UHG".rOUi wML1 i CONSULTANT COSTS Delia Smith-West 5,500 EQUIPMENT (Itemize) Computers forTNB's (2,500 each) 5,000 SQL Server 7,500 12,500 SUPPLIES (Itemize by category) Project-related expenses 1,000 ' ^1000 TRAVEL 2 staff members to two