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Rationale and Design of Family-Based Approach in a Minority Community Integrating Systems–Biology for Promotion of Health (FAMILIA) - 27/09/17

Doi : 10.1016/j.ahj.2017.02.020 
Sameer Bansilal, MD, MS , Rajesh Vedanthan, MD, MPH, Jason C. Kovacic, MD, PhD, Ana Victoria Soto, MD, Jacqueline Latina, MD, Johan L.M. Björkegren, MD, Risa Jaslow, MS, RDN, Maribel Santana, BS, Samantha Sartori, PhD, Chiara Giannarelli, MD, PhD, Venkatesh Mani, PhD, Roger Hajjar, MD, Eric Schadt, PhD, Andrew Kasarskis, PhD, Zahi A. Fayad, PhD, Valentin Fuster, MD, PhD,
 Icahn School of Medicine at Mount Sinai, New York, NY 

Reprint requests: Sameer Bansilal, MD, MS, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030 New York, NY 10029.Icahn School of Medicine at Mount SinaiOne Gustave L. Levy PlaceBox 1030New YorkNY10029

Abstract

Background

The 2020 American Heart Association Impact Goal aims to improve cardiovascular health of all Americans by 20% while reducing deaths from cardiovascular disease and stroke by 20%. A large step toward this goal would be to better understand and take advantage of the significant intersection between behavior and biology across the entire life-span. In the proposed FAMILIA studies, we aim to directly address this major knowledge and clinical health gap by implementing an integrated family-centric health promotion intervention and focusing on the intersection of environment and behavior, while understanding the genetic and biologic basis of cardiovascular disease.

Methods

We plan to recruit 600 preschool children and their 600 parents or caregivers from 12-15 Head Start schools in Harlem, NY, and perform a 2:1 (2 intervention/1 control) cluster randomization of the schools. The preschool children will receive our intensive 37-hour educational program as the intervention for 4 months. For the adults, those in the “intervention” group will be randomly assigned to 1 of 2 intervention programs: an “individual-focused” or “peer-to-peer based.” The primary outcome in children will be a composite score of knowledge (K), attitudes (A), habits (H), related to body mass index Z score (B), exercise (E), and alimentation (A) (KAH-BEA), using questionnaires and anthropometric measurements. For adults, the primary outcome will be a composite score for behaviors/outcomes related to blood pressure, exercise, weight, alimentation (diet) and tobacco (smoking; Fuster-BEWAT score). Saliva will be collected from the children for SNP genotyping, and blood will be collected from adults for RNA sequencing to identify network models and predictors of primary prevention outcomes.

Conclusion

The FAMILIA studies seek to demonstrate that targeting a younger age group (3-5 years) and using a family-based approach may be a critical strategy in promoting cardiovascular health across the life-span.

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 Clinical Trial Registration: NCT02343341 and NCT02481401.
 The FAMILIA study is funded by the American Heart Association (14SFRN20490315). R.V. is supported by the Fogarty International Center of the National Institutes of Health (K01TW009218). J.C.K. is supported by the National Heart, Lung, and Blood Institute (K08HL111330), a Foundation Leducq Transatlantic Network of Excellence Award and AstraZeneca. V.F. is supported by the National Heart, Lung, and Blood Institute (5U01HL114200). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health or the American Heart Association.


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Vol 187

P. 170-181 - Maggio 2017 Ritorno al numero
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