A novel family-based intervention trial to improve heart health: FIT Heart: results of a randomized controlled trial.

ABSTRACT

BACKGROUND: Family members of patients with cardiovascular disease (CVD) may be at increased risk due to shared genes and lifestyle. Hospitalization of a family member with CVD may represent a "motivational moment" to take preventive action. METHODS AND RESULTS: A randomized, controlled clinical trial was conducted in healthy adult family members (N=501; 66% female; 36% nonwhite; mean age, 48 years) of patients hospitalized with CVD to evaluate a special intervention (SI) with personalized risk factor screening, therapeutic lifestyle-change counseling, and progress reports to physicians versus a control intervention (CIN) on the primary outcome, mean percent change in low-density lipoprotein cholesterol (LDL-C), and other risk factors. Validated dietary assessments and standardized risk factors were obtained at baseline and 1 year (94% follow-up). At baseline, for 93% of subjects, saturated fat comprised > or = 7% of total caloric intake, and 79% had nonoptimal LDL-C levels (of which 50% were unaware). There was no difference in the SI versus the CIN with respect to the mean percent change in LDL-C (-1% versus -2%, respectively; P=0.64), owing to a similar significant reduction in LDL-C in both groups (-4.4 mg/dL and -4.5 mg/dL, respectively). Diet score significantly improved in the SI versus the CIN (P=0.04). High-density lipoprotein cholesterol declined significantly in the CIN but not in the SI (-3.2% [95% CI, -5.1 to -1.3] versus +0.3% [95% CI, -1.7 to +2.4]; P=0.01). At 1 year, SI subjects were more likely than controls to exercise >3 days per week (P=0.04). CONCLUSIONS: The SI was not more effective than the CIN in reducing the primary end point, LDL-C. The screening process identified many family members of hospitalized patients with CVD who were unaware of their risk factors, and further work is needed to develop and test interventions to reduce their CVD risk.