Rural Lifestyle Eating and Activity Program (Rural LEAP)

描述（由申请人提供）：与城市地区相比，农村地区较高的肥胖率和久坐行为是心血管疾病（CVD）发病率和死亡率较高的重要因素。然而，很少有研究关注如何改变城市/农村心脏病差异的这些重要影响。生活方式干预措施可以产生足以改善健康的体重减轻，但现有的研究在两个关键因素方面是有限的：(a)长期维持治疗效果和(b)向服务不足的人群转化和传播。在一系列的有效性试验中，我们的农村肥胖研究项目已经证明了通过美国农业部合作推广服务（CES）现有基础设施提供生活方式项目的可行性和有效性，该服务在全国有2900多个办事处，其使命包括改善营养和健康。我们还证明，我们可以通过包括面对面治疗会议或个人电话咨询在内的延伸护理项目来改善治疗的长期效果。然而，这两种选择都需要相对较高的成本，这阻碍了它们在农村社区的采用。在最近发表的一项试点研究中，我们证明了一种基于群体的电话干预对农村地区肥胖成年人的有效性。这种高度创新的方法解决了获取障碍，在保密的环境中提供团体支持，似乎与个人电话治疗一样有效。群体支持对农村居民来说可能尤其重要，因为他们往往被孤立，对隐私的担忧加剧，生活质量水平较低。这条研究路线的下一个合乎逻辑的步骤是进行一项随机对照试验，以评估这种可能更有效的模式对农村社区肥胖管理的长期影响。我们建议在肥胖成人（N=540）中进行一项单盲、随机对照的“有效性”试验，以评估通过个人或团体电话咨询提供的扩展护理计划与健康教育控制（CTRL）条件相比，对长期（22个月）体重变化的影响。我们的主要假设是，在22个月时，个体和群体干预都比CTRL组产生更大的体重减轻。我们将在长期随访中评估每种情况下表现出临床显著体重减轻（初始体重的5%）的参与者的比例。我们还将检查治疗对心血管疾病危险因素的影响，并评估干预措施的成本和成本效益。

DESCRIPTION (provided by applicant): Higher rates of obesity and sedentary behavior represent significant contributors to the greater prevalence of cardiovascular disease (CVD) morbidity and mortality observed in rural versus urban areas. Yet little research attention has been given to modifying these important influences on the urban/rural disparity in heart disease. Lifestyle interventions can produce weight reductions of sufficient magnitude to improve health, but the existing research is limited with respect to two critical factors: (a) the long-term maintenance of treatment effects and (b) translation and dissemination to underserved populations. In a series of effectiveness trials, our rural obesity research program has demonstrated the feasibility and effectiveness of delivering lifestyle programs through the existing infrastructure of the USDA Cooperative Extension Service (CES), which has more than 2,900 offices nationwide and whose mission includes improving nutrition and health. We have also demonstrated that we can improve the long-term effects of treatment via extended-care programs consisting of either face-to-face treatment sessions or individual telephone counseling. However, both of these options entail relatively high costs, which inhibit their adoption in rural communities. In a recently published pilot study, we demonstrated the effectiveness of a group-based telephone intervention for obese adults from rural areas. This highly innovative approach addresses barriers to access, provides group support in a confidential setting, and appears to be as effective as individual phone treatment. Group support may be especially important for rural residents who tend to be isolated, have heightened concerns about privacy, and report lower levels of quality of life. The next logical step in this lne of research is to conduct a randomized controlled trial to evaluate the long-term effects of this potentially more efficient mode of providing extended care for the management of obesity in rural communities. We propose to conduct a single-blind, randomized controlled "effectiveness" trial in obese adults (N=540) to evaluate the effects of extended-care programs delivered via INDIVIDUAL or GROUP telephone counseling, compared to a health education control (CTRL) condition, on long-term (22 month) changes in body weight. Our principal hypothesis is that both the INDIVIDUAL and GROUP interventions will produce greater weight reductions at 22 months than the CTRL condition. We will evaluate the proportion of participants in each condition who demonstrate clinically significant weight losses (> 5% of initial body weight) at long-term follow-up. We also will examine the effects of treatment on CVD risk factors, and we will evaluate the costs and cost effectiveness of the interventions.