A randomized controlled trial to evaluate the effectiveness of CouPLES: A spouse-assisted lifestyle change intervention to improve low-density lipoprotein cholesterol

Abstract: Objective: This randomized controlled trial evaluated the effectiveness of a telephone-delivered, spouse-assisted lifestyle intervention to reduce patient LDL-C. Method: From 2007 to 2010, 255 outpatients with LDL-C>76mg/dL and their spouses from the Durham Veterans Affairs Medical Center were randomized to intervention or usual care. The intervention comprised nine monthly goal-setting telephone calls to patients and support planning calls to spouses. Outcomes were assessed at 11months. Results: Patients were 95% male and 65% White. LDL-C did not differ between groups (mean difference=2.3mg/dL, 95% CI=−3.6, 8.3, p=0.44), nor did the odds of meeting goal LDL-C (OR=0.95, 95% CI=0.6, 1.7; p=0.87). Intakes of calories (p=0.03), total fat (p=0.02), and saturated fat (p=0.02) were lower for the intervention group. Cholesterol and fiber intake did not differ between groups (p=0.11 and 0.26, respectively). The estimated rate of moderate intensity physical activity per week was 20% higher in the intervention group (IRR=1.2, 95% CI=1.0, 1.5, p=0.06). Most participants did not experience a change in cholesterol medication usage during the study period in the intervention (71.7%) and usual care (78.9%) groups. Conclusion: This intervention might be an adjunct to usual primary care to improve adherence to lifestyle behaviors. [Copyright &y& Elsevier]