Translating the DPP in an HMO Setting: Telephone Intervention Planning Grant

概述/摘要：本提案响应PAR-06-358“糖尿病和肥胖预防和控制转化研究计划资助”。据估计，到2050年，将有3000万美国成年人患有2型糖尿病。造成这一全国性趋势的原因是肥胖的流行。三个随机试验表明，强化行为干预可以预防或延缓糖尿病的发病。这项初步研究的目的是为未来的随机、对照、III期试验提供信息，该试验以人群为基础，采用电话、运动和减肥干预，将糖尿病预防项目的研究结果转化为实践。1:1的电话干预将与常规护理（每组30名参与者，15名男性和15名女性）进行比较。干预将以每周20分钟的电话形式进行，持续10周，每两周进行3次维护电话，每月进行2次维护电话，在24周内共进行15次电话。研究结果将在基线、10周和24周时进行测量。我们的具体目标是：1)评估电话减肥和运动干预的可行性和可接受性，包括招募、接受干预和继续参与；2)对干预的有效性进行初步评估，包括干预组与常规护理组在第10周和第24周的体重减轻情况，干预组与常规护理组的身体活动情况；3)告知全面有效性试验的设计和实施，包括改进干预，改进测量策略，获取数据以改进样本量估计，并使用干预时间日志来估计项目成本。

DESCRIPTION (provided by applicant): SUMMARY/ABSTRACT: This proposal responds to PAR-06-358 "Planning Grants for Translational Research for the Prevention and Control of Diabetes and Obesity." It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing to this national trend is the obesity epidemic. Three randomized trials have demonstrated that intensive behavioral interventions can prevent or delay the onset of diabetes. The purpose of this pilot study is to inform a future randomized, controlled, Phase III trial of a population-based, telephonic, exercise and weight loss intervention to translating the findings of the Diabetes Prevention Program into practice. The 1:1 telephonic intervention will be compared to usual care (30 participants in each group, 15 male and 15 female). The intervention will be delivered in weekly, 20 minute calls, for 10 weeks, with maintenance calls biweekly times 3, and monthly times 2, for a total of 15 calls over 24 weeks. Study outcomes will be measured at baseline, 10 weeks, and 24 weeks. Our specific aims are to: 1) Evaluate the feasibility and acceptability of a telephone-based weight loss and exercise intervention, including recruitment, intervention acceptance, and continued participation; 2) Conduct a preliminary evaluation of the intervention's effectiveness including, weight loss at 10 and 24 weeks in the intervention vs. usual-care groups and physical activity in the intervention vs. usual-care groups; and 3) Inform the design and implementation of a full-scale effectiveness trial, including refining the intervention, refining measurement strategies, obtaining data to refine sample size estimates, and using intervention time-logs to estimate program costs. NARRATIVE: The Diabetes Prevention Project and other intervention trials showed that intensive weight loss and exercise interventions can reduce diabetes risk. The public health challenge is to translate the results of these efficacy trials into effective, population-based programs that can cost- effectively reach large numbers of people at risk, achieve similar weight loss and exercise goals, and sustain these changes over time. Our goal is to translate the DPP into a telephone-based intervention that meets this challenge.