Author + information
- Received August 28, 2019
- Revision received October 17, 2019
- Accepted October 22, 2019
- Published online January 6, 2020.
- Rodrigo Fernandez-Jimenez, MD, PhDa,b,c@rodrigo_fjez,
- Risa Jaslow, MS, RDNa,
- Sameer Bansilal, MD, MSa,
- Raquel Diaz-Munoz, RN, MSa,
- Monali Fatterpekar, PhDa,
- Maribel Santana, BSa,
- Andrea Clarke-Littman, BSa,
- Jacqueline Latina, MD, MSa,
- Ana V. Soto, MDd,
- Christopher A. Hill, BAa,
- Mohamed Al-Kazaz, MDa,
- Rajeev Samtani, MDa,
- Rajesh Vedanthan, MD, MPHe,
- Chiara Giannarelli, MD, PhDa,
- Jason C. Kovacic, MD, PhDa,
- Emilia Bagiella, PhDf,
- Andrew Kasarskis, PhDa,
- Zahi A. Fayad, PhDa,g and
- Valentin Fuster, MD, PhDa,b,∗ (, )@MountSinaiHeart@CNIC_Cardio
- aThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- bCentro Nacional de Investigaciones Cardiovasculares, Madrid, Spain
- cCIBER de Enfermedades Cardiovasculares, Madrid, Spain
- dMount Sinai Medical Center, Miami Beach, Florida
- eDepartment of Population Health, NYU School of Medicine, New York, New York
- fCenter for Biostatistics, Icahn School of Medicine at Mount Sinai, New York, New York
- gTranslational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- ↵∗Address for correspondence:
Dr. Valentin Fuster, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, New York, New York 10029.
Background The current trends of unhealthy lifestyle behaviors in underserved communities are disturbing. Thus, effective health promotion strategies constitute an unmet need.
Objectives The purpose of this study was to assess the impact of 2 different lifestyle interventions on parents/caregivers of children attending preschools in a socioeconomically disadvantaged community.
Methods The FAMILIA (Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health) study is a cluster-randomized trial involving 15 Head Start preschools in Harlem, New York. Schools, and their children’s parents/caregivers, were randomized to receive either an “individual-focused” or “peer-to-peer–based” lifestyle intervention program for 12 months or control. The primary outcome was the change from baseline to 12 months in a composite health score related to blood pressure, exercise, weight, alimentation, and tobacco (Fuster-BEWAT Score [FBS]), ranging from 0 to 15 (ideal health = 15). To assess the sustainability of the intervention, this study evaluated the change of FBS at 24 months. Main pre-specified secondary outcomes included changes in FBS subcomponents and the effect of the knowledge of presence of atherosclerosis as assessed by bilateral carotid/femoral vascular ultrasound. Mixed-effects models were used to test for intervention effects.
Results A total of 635 parents/caregivers were enrolled: mean age 38 ± 11 years, 83% women, 57% Hispanic/Latino, 31% African American, and a baseline FBS of 9.3 ± 2.4 points. The mean within-group change in FBS from baseline to 12 months was ∼0.20 points in all groups, with no overall between-group differences. However, high-adherence participants to the intervention exhibited a greater change in FBS than their low-adherence counterparts: 0.30 points (95% confidence interval: 0.03 to 0.57; p = 0.027) versus 0.00 points (95% confidence interval: −0.43 to 0.43; p = 1.0), respectively. Furthermore, the knowledge by the participant of the presence of atherosclerosis significantly boosted the intervention effects. Similar results were sustained at 24 months.
Conclusions Although overall significant differences were not observed between intervention and control groups, the FAMILIA trial highlights that high adherence rates to lifestyle interventions may improve health outcomes. It also suggests a potential contributory role of the presentation of atherosclerosis pictures, providing helpful information to improve future lifestyle interventions in adults.
This study was funded by the American Heart Association, under grant No 14SFRN20490315. The Centro Nacional de Investigaciones Cardiovasculares is supported by the Instituto de Salud Carlos III, the Ministerio de Ciencia, Innovación y Universidades, and the Pro CNIC Foundation, and is a Severo Ochoa Center of Excellence (SEV-2015-0505). Dr. Fernandez-Jimenez is a recipient of funding from the European Union Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No 707642. Dr. Bansilal is an employee of Bayer US. Dr. Kovacic has received honoraria less than $5,000 from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. George A. Mensah, MD, served as Guest Associate Editor for this paper. P.K. Shah, MD, served as Guest Editor-in-Chief for this paper.
- Received August 28, 2019.
- Revision received October 17, 2019.
- Accepted October 22, 2019.
- 2020 The Authors