Randomized Trial of Exercise Promotion in Primary Care

描述（由申请人提供）：糖尿病是一种患病率正在上升的破坏性疾病。有规律的体育活动可以显著改善所有人的健康，包括糖尿病患者和糖尿病前期患者。然而，只有5%的美国成年人的运动量达到了美国国家指导标准。卫生部门是促进身体活动的重要场所，因为它能够接触和影响大量人群。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、自我报告的身体活动作为结果以及结果不可推广的阻碍。我们建议在Kaiser Permanente Southern California （KPSC）的成员中进行试验，这是一个高度种族/民族多样性的综合健康计划，其大多数成员是拉丁裔。我们将以现有的KP创新为基础，在每次门诊时评估身体活动，提出一项试验，由初级保健提供者确定患者是否适合增加身体活动，提供简短的建议，并转诊患者或进行身体活动咨询。然后招募符合条件的患者进行为期2年的中等强度的电话行为咨询干预或常规护理。我们把试验的重点放在患有糖尿病前期或糖尿病的成年人身上，因为他们患心脏代谢并发症的风险很高，而且他们可以从定期的体育锻炼中获得巨大的好处，所以没有给他们开胰岛素。干预，个体化的动机访谈方法，是推广到其他卫生保健服务系统。电子病历将提供次要结果的数据。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纳入初级保健服务。如果是这样，干预可以

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.