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.
RCT Entities:
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.
Authors: Lucia A Hindorff; Praveen Sethupathy; Heather A Junkins; Erin M Ramos; Jayashri P Mehta; Francis S Collins; Teri A Manolio Journal: Proc Natl Acad Sci U S A Date: 2009-05-27 Impact factor: 11.205
Authors: Donald M Lloyd-Jones; Yuling Hong; Darwin Labarthe; Dariush Mozaffarian; Lawrence J Appel; Linda Van Horn; Kurt Greenlund; Stephen Daniels; Graham Nichol; Gordon F Tomaselli; Donna K Arnett; Gregg C Fonarow; P Michael Ho; Michael S Lauer; Frederick A Masoudi; Rose Marie Robertson; Véronique Roger; Lee H Schwamm; Paul Sorlie; Clyde W Yancy; Wayne D Rosamond Journal: Circulation Date: 2010-01-20 Impact factor: 29.690
Authors: Valur Emilsson; Gudmar Thorleifsson; Bin Zhang; Amy S Leonardson; Florian Zink; Jun Zhu; Sonia Carlson; Agnar Helgason; G Bragi Walters; Steinunn Gunnarsdottir; Magali Mouy; Valgerdur Steinthorsdottir; Gudrun H Eiriksdottir; Gyda Bjornsdottir; Inga Reynisdottir; Daniel Gudbjartsson; Anna Helgadottir; Aslaug Jonasdottir; Adalbjorg Jonasdottir; Unnur Styrkarsdottir; Solveig Gretarsdottir; Kristinn P Magnusson; Hreinn Stefansson; Ragnheidur Fossdal; Kristleifur Kristjansson; Hjortur G Gislason; Tryggvi Stefansson; Bjorn G Leifsson; Unnur Thorsteinsdottir; John R Lamb; Jeffrey R Gulcher; Marc L Reitman; Augustine Kong; Eric E Schadt; Kari Stefansson Journal: Nature Date: 2008-03-16 Impact factor: 49.962
Authors: Hua Zhong; John Beaulaurier; Pek Yee Lum; Cliona Molony; Xia Yang; Douglas J Macneil; Drew T Weingarth; Bin Zhang; Danielle Greenawalt; Radu Dobrin; Ke Hao; Sangsoon Woo; Christine Fabre-Suver; Su Qian; Michael R Tota; Mark P Keller; Christina M Kendziorski; Brian S Yandell; Victor Castro; Alan D Attie; Lee M Kaplan; Eric E Schadt Journal: PLoS Genet Date: 2010-05-06 Impact factor: 5.917