title: 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.
  
  
  METHODS
  From 2007 to 2010, 255 outpatients with LDL-C>76 mg/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 11 months.
  
  
  RESULTS
  Patients were 95% male and 65% White. LDL-C did not differ between groups (mean difference = 2.3 mg/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.
  
  
  CONCLUSIONS
  This intervention might be an adjunct to usual primary care to improve adherence to lifestyle behaviors.
authors.affiliation: Center for Health Services Research in Primary Care, Durham Veterans Affairs Medical Center, Durham, NC, USA. voils001@mc.duke.edu
authors.forename: Corrine I
authors.initials: CI
authors.lastname: Voils
authors.forename: Cynthia J
authors.initials: CJ
authors.lastname: Coffman
authors.forename: William S
authors.initials: WS
authors.lastname: Yancy
authors.forename: Morris
authors.initials: M
authors.lastname: Weinberger
authors.forename: Amy S
authors.initials: AS
authors.lastname: Jeffreys
authors.forename: Santanu
authors.initials: S
authors.lastname: Datta
authors.forename: Stacey
authors.initials: S
authors.lastname: Kovac
authors.forename: Jamiyla
authors.initials: J
authors.lastname: McKenzie
authors.forename: Rose
authors.initials: R
authors.lastname: Smith
authors.forename: Hayden B
authors.initials: HB
authors.lastname: Bosworth
mesh_terms: D000368:Aged; D016001:Confidence Intervals; D005260:Female; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D006995:Hypobetalipoproteinemias / Q000178:diet therapy / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009657:North Carolina; D016017:Odds Ratio; D011209:Power, Psychological; D040242:Risk Reduction Behavior; D012944:Social Support; D018454:Spouses