Randomized Trial of Exercise Promotion in Primary Care

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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.