Randomized Trial of Exercise Promotion in Primary Care

描述（由申请人提供）：糖尿病是一种破坏性疾病，患病率正在增加。有规律的身体活动可以显著改善所有人的健康，包括糖尿病和糖尿病前期患者。然而，只有5%的美国成年人足够活跃，以满足美国国家指南。卫生部门是促进体育活动的一个重要环境，因为它能够接触和影响大量的人。先前在初级保健环境中进行的试验受到短期干预、干预强度不足、自我报告的体力活动作为结果以及结果的非普遍性的阻碍。我们提出了一项试验，包括凯撒永久南加州（KPSC），一个综合的健康计划，具有高度种族/民族多样性，其大多数成员是拉丁美洲人的成员。我们将在现有的KP创新的基础上，通过提出一项试验，在该试验中，初级保健提供者确定患者是否适合增加体力活动，提供简短的建议，并介绍患者或体力活动咨询。然后招募符合条件的患者进行为期2年的中等强度电话行为咨询干预或常规护理。我们将试验重点放在患有糖尿病前期或糖尿病的成年人身上，这些人没有处方胰岛素，因为他们患心脏代谢并发症的风险很高，并且他们可以从定期的体力活动中获得巨大的益处。干预，个性化的动机访谈的方法，是推广到其他医疗保健服务系统。电子病历将为次要结局提供数据。我们的长期目标是确定这种身体活动干预是否可以成功地融入初级保健服务。如果是这样，干预可以 因此，数以百万计的久坐不动的糖尿病或糖尿病前期患者可以获得个人建议和体育活动咨询。为此，我们的主要目的是确定与常规护理相比，研究干预是否增加了2型糖尿病或糖尿病前期患者在基线和24个月之间的体力活动（通过加速度计评估）。我们的次要目的是1）确定干预是否改善了体重指数（BMI），血红蛋白A1 C，血压，血脂和生活质量，2）确定干预的成本效益。这项研究有可能对临床预防实践产生非常高的影响。体育活动可以改善许多疾病和状况，但在初级保健中受到严重忽视。通过记录基于物理活动的客观测量的实际干预在初级保健中的成本和效果，本研究将促进初级保健实践的高度显著转变。

DESCRIPTION (provided by applicant): Diabetes is a devastating disease that is increasing in prevalence. Regular physical activity markedly improves health for all individuals, including those with diabetes and pre-diabetes. However, only 5% of American adults are sufficiently active to meet U.S. national guidelines. The health sector is an important setting to promote physical activity because of its ability to reach and influence large numbers of people. Previous trials in the primary care setting have been hindered by short-term interventions, insufficient intervention intensity, self- reported physical activity as the outcome, and non-generalizability o results. We propose a trial including members of Kaiser Permanente Southern California (KPSC), an integrated health plan with high racial/ethnic diversity and whose majority membership is Latino. We will build on an existing KP innovation of assessing physical activity at every outpatient visit by proposing a trial in which the primary care provider determines the suitability of a patient to increase physical activity, provides brief advice, and refers patients or physical activity counseling. Eligible patients are then recruited to a 2-year, medium-intensity telephone behavioral counseling intervention or usual care. We focus the trial on adults who have pre-diabetes or diabetes who are not prescribed insulin because of their high risk for cardio-metabolic complications and the great benefit they can obtain from regular physical activity. The intervention, individualized by the motivational interviewing approach, is generalizable to other health care delivery systems. Electronic medical records will provide data for secondary outcomes. Our long-term goal is to determine if such a physical activity intervention can be successfully integrated into primary care services. If so, the intervention can be scaled so millions of sedentary patients with diabetes or pre-diabetes can receive personal advice and physical activity counseling. To this end, our primary aims is to determine if the study intervention, compared to usual care, increases physical activity (assessed by accelerometry) between baseline and 24 months in patients with type 2 diabetes or pre-diabetes. Our secondary aims are to 1) determine if the intervention improves body mass index (BMI), hemoglobin A1C, blood pressure, lipids, and quality of life, and 2) determine the cost-effectiveness of the intervention. This study has the potential for a very high impact on clinical preventive practices. Physical activity improves numerous diseases and conditions and is seriously neglected in primary care. By documenting the costs and effects of a practical intervention based in primary care on an objective measure of physical activity, this study will promote a highly significant shift in primary care practice.