Study Summary

In the FAMILIA study, 635 participants were enrolled in a parallel-group, cluster-randomized controlled trial of the impact of lifestyle interventions on cardiovascular health. Participants were from a socioeconomically disadvantaged, multiethnic community in Harlem, New York City, USA and were parents and caregivers (mean age 38 +/- 11 years) of children who attended one of 15 preschools. Participants were randomly assigned to intervention (12 months of individual or peer-to-peer lifestyle programs) or control. No differences were observed in the change in primary outcome of Fuster–BEWAT score (FBS; a composite cardiovascular health score encompassing blood pressure, exercise, weight [BMI], alimentation [fruit and vegetable consumption], and tobacco use) between the intervention and control groups between 0 and 12 months ; this observation was sustained at 24 months. A dose–response relationship was observed, however, with high-adherence participants (those attending >50% of sessions) demonstrating significant improvement in FBS. 81% in individual programs and 66% in peer-to-peer programs achieved high adhererence. In addition, the presentation to subjects of evidence of atherosclerosis on their own bilateral carotid/femoral ultrasound helped induce lifestyle changes in adults as evidence by improved FBS.


Study Strengths: The investigators evaluated multiple lifestyle intervention techniques, including one-to-one sessions, a personal activity monitoring device, and group sessions with peer leaders. Evaluation of FBS at 12 and 24 months allowed assessment of immediate and sustained effects of the interventions. Subgroup analysis included several social determinants of health, such as age, sex, race or ethnicity, place of birth, income level, and education level.

Study Limitations: Participants in the control group received a similar health-based curriculum to their children starting 4 months into the study, as well as other important health advice, which could have reduced the effect size compared with a control population with no formal health education program. Approximately one-third of the population was lost to follow-up or had incomplete data, which could also have reduced the effect size. Use of the FBS provided a validated and reproducible, semiquantifiable measure of cardiovascular health over time. However, this score does not evaluate the presence of subclinical atherosclerosis, which could lead to incomplete assessment of overall health, particularly given the young average age of the participants and the short duration of the study.

Next Steps/Clinical Perspective: The study involved an important population of parents and caregivers of young children in an underserved environment. Improving health via modifiable risk factors in this group could be key to reducing racial, ethnic, and socioeconomic health disparities in a sustainable and cost-effective manner. Future investigation could expand to other geographic areas to determine generalizability of the methods and interventions in other resource-limited settings. Although the study did not show a significant difference between intervention and control in the cardiovascular health measure used, the data trended towards benefit with increased utilization, and may underestimate the impact such programs could have in an underserved population.

Trial Reference

Fernandez-Jimenez,  R. et al. Different lifestyle interventions in adults from underserved communities: the FAMILIA trial. J. Am. Coll. Cardiol. doi:10.1016/j.jacc.2019.10.021.