PRIDE: Program to Reduce Incontinence by Diet & Exercise

PRIDE：通过饮食减少失禁的计划

• 批准号: 7257788
• 负责人: Deborah G Grady
• 金额: $ 40.7万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7257788
• 关键词: Acer; Arkansas; Authorization documentation; Behavioral; Body Weight decreased; Budgets; California; Caring; Categories; Clinical; Clinical Trials; Computers; Data; Disclosure; Doctor of Medicine; Doctor of Philosophy; Equipment; Frequencies; Health; Human Resources; Incontinence; Institution; Instruction; Intervention; Last Name; Maintenance; Methods; Motivation; Names; Obesity; Outcome; Overweight; Performance; Principal Investigator; Quality of life; Randomized; Research Design; Research Personnel; Risk; Role; San Francisco; Standards of Weights and Measures; Tea; Travel; Universities; Upper arm; Urinary Incontinence; Wages; Weight maintenance regimen; Woman; Women' s Health; base; behavior change; daily functioning; diet and exercise; experience; innovation; member; novel; novel strategies; obesity treatment; programs; skills; theories; weight maintenance

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

尿失禁是女性的常见问题，会导致痛苦和生活质量下降 以及日常功能的严重限制，超重女性的泌尿风险显着增加。 短期初步数据显示，超过 65% 的失禁女性体重超重。 研究表明，减轻体重可能会显着减少失禁发作，因此，失重可能会减少失禁的发生。 提出了一种有前途的尿失禁治疗新方法，该方法可能会产生一系列的效果 除了减少尿失禁频率之外，还可以改善更广泛的健康状况。 建议对 330 名患有尿失禁的超重和肥胖女性进行随机分组（两次中各 165 名） 临床中心）交给为期 6 个月的强化行为体重控制规划师进行常规护理，以确定 减肥对失禁频率和生活质量的短期影响，以确定最有可能的女性 从减肥中受益并开始探索失禁的尿动力学机制 减肥后的改善。 为了最大限度地发挥减肥对尿失禁的持久影响，有必要生产 然而，维持体重仍然是肥胖领域的一个挑战。 我们建议评估一项创新的、以理论为指导的体重维持计划，该计划的重点是 增加对行为改变努力的动力和承诺，并将其与更标准的进行比较， 以技能为重点的体重维持计划。完成为期 6 个月的减肥计划后，女性 减肥组将被随机分配到为期 12 个月的标准、基于技能的维护计划员和 以动机为中心的维持干预的结果将包括体重减轻、失禁频率。 以及 18 个月时的生活质量如果对尿失禁女性有效，则该方法和策略。 可以在其他肥胖人群中研究创新的以动机为中心的维持干预措施。 WIN-失禁减重网络-汇集了一群独特的杰出和 经验丰富的研究人员在尿失禁、肥胖治疗和多中心合作方面拥有专业知识 在三个机构进行的积极临床试验，拟议的研究设计将使我们能够有效地评估 尿失禁的新疗法和增强体重维持的有前途的方法， 因此，为对妇女健康至关重要的几个临床领域做出实质性贡献。 绩效 Sm=(S)（组织、城市、州） 加利福尼亚大学旧金山分校。 阿肯色大学 关键人员 请参阅说明。根据需要使用 conflnusfibnpages 提供所需的信息，格式如下所示。 从首席研究员开始，按照字母顺序，姓氏在前。 名称 组织在项目中的角色 Grady, Deborah，医学博士加州大学旧金山分校首席研究员 Subak, Leslee L，医学博士。加州大学旧金山分校联合首席研究员 Brown, Jeanette S.，医学博士加州大学旧金山分校研究员 Viittlnhoff. 博士，旧金山加利福尼亚大学生物统计学家 韦斯特，迪莉娅·史密斯，阿肯色大学顾问或 披露许可声明仅适用于 SBIR/STTR Q 是D否。 ¿ 0'd DdDHn dSDfl NOIZ 1W 82:¿ T ¿ 00¿ -92-Onb 校长 inwaEtinatnr/项目总监（姓、名、中）：^¿格拉利。 通过 国际预算期详细预算 直接COS??仅 TS 2003 年 7 月 1 日 2004 年 6 月 30 日 人员（仅限申请组织）类型“美元金额请求！” DRT INST- EffQ N 基本工资福利的作用 名称 项目（月） PR DJ 要求的薪资 福利总计 主要的 Deborah Grady，医学博士 研究员 12 5% * 171,900 8,595 1,461 10,056 莱斯利·苏巴克 (Leslee Subak)，医学博士 C¿ -pl p^tf* 12 ^S"WJh%^ . 140,492 'lS&Pe -Zrt-65 ¿-4&t^T.(3r~r2- 珍妮特·布朗 合作者 12 3% * 171,900 4,298 731 5,029 J,ud,y M..acer 项目总监 12 e>0% 82,398 41,199 7,004 48,203 EricVirtinghoff 统计学家 12 10% 108,395 10,839 2,385 13,224 TEA 数据程序员 数据Pr¿ 9 夯锤 12 2!0% 55,000 11,000 2,420 13,420 TEA 项目助理 ProjectAssistant 12 ¿ >0% - 39,595 19,798 4,356 24,154 ^ .u 小计 "实际工资超出上限13*677 2*52？1T UHG".rOUi wML1 i 顾问费用 迪莉娅·史密斯-韦斯特 5,500 设备（逐项列出） TNB 计算机（每台 2,500 台） 5,000 SQL Server 7,500 12,500 用品（按类别列出） 项目相关费用 1,000 ' ^1000 旅行 2 名工作人员对 2 名