Family-based Approach to Promotion of Health - FAMILIA (Project 2)

Aim 1 - Pilot: To identify the contextual factors, facilitators and barriers that may impact
the implementation of a lifestyle intervention program for adults in Harlem, using
qualitative research methods: 1) focus group discussions among a representative cohort of
adults; 2) focus group discussions among community leaders; and 3) Pilot studies of
feasibility of interventions in the representative cohort of adults.

Subsidiary Aim 1.1: To use identified facilitators and barriers to develop a contextually and
culturally appropriate model for an adult lifestyle intervention program.

Subsidiary Aim 1.2: To implement a pilot intervention of the contextually and culturally
adapted program among a sample of parents/caregivers of children in preschools in Harlem.

The investigators will assess for acceptability and feasibility, and make any necessary
modifications prior to the implementation of the cluster-randomized trial. This aim will be
carried out at 2 preschools in Harlem, NY by including the parents and caregivers of
pre-school children. The final intervention program that results from this
intervention-mapping program will be piloted in parent groups of 8-10.

Aim 2 - Randomization: To determine (i) the impact of two intensive lifestyle interventions
on promoting and improving healthy behaviors (increased physical activity, smoking cessation
etc.) and biological parameters (lipids, sugar) to lower cardiovascular risk, (ii) the impact
of the presence of atherosclerosis on health behaviors and (iii) the impact of the lifestyle
interventions on atherosclerosis among approximately 600 asymptomatic at-risk adults.

Hypothesis: Adults receiving the lifestyle intervention programs will demonstrate a greater
improvement in healthy behaviors and biological parameters compared to controls.

Hypothesis: Knowledge of presence of atherosclerosis as defined by three-dimensional vascular
ultrasound will lead to greater improvement in healthy behaviors.

Hypothesis: Adults receiving the lifestyle intervention programs will demonstrate a lesser
progression or regression of three-dimensional vascular ultrasound quantified atherosclerosis
compared to controls.

For this aim, the investigators will recruit parents and caregivers of pre-school children
from up to twenty schools in Harlem, NY and perform a 3:2 (3 intervention, 2 control) cluster
randomization of the schools. Those schools in the "intensive intervention" group will be
randomly assigned to one of two interventions- an Intensive Individual Intervention Program"
(IIIP) developed through the intervention mapping program described in aim 1 or 'Peer-To-Peer
Program - Intervention" (PPPI), refined during that same pilot phase. The primary outcome
will be a composite score consisting of a 0-3 scale for behaviors/outcomes related to Blood
pressure, Exercise, Weight, Alimentation (diet) and Tobacco (smoking) [Fuster-BEWAT score].
Primary assessments will be performed at baseline, at the end of the intervention
(approximately 12 months, peak effect), and at approximately 24 months (sustainability). The
12 month assessment will be used to calculate the between group difference for the change in
the Fuster-BEWAT score and will be the primary outcome measure for the adults. To evaluate
the sustainability of the impact of the two intensive lifestyle interventions on healthy
behaviors and biological parameters 12 months after the intervention program ends. For the
assessment of secondary outcome measures, participants will undergo point of care testing for
a lipid panel and blood sugar assessment, and a three-dimensional vascular ultrasound
(carotid, ileo-femoral) to assess for presence and extent of atherosclerosis at baseline and
after the intervention period.

Blood will be collected from all adults who provide consent at enrollment and at the end of
the intervention period. Blood from adults will be used to isolate DNA and plasma. In
addition, by in vitro culture of blood-derived mononuclear cells, we will derive macrophages,
which will then be driven to become foam cells. RNA will be isolated from pre- and
post-intervention blood samples. Genomic data obtained from adult blood samples will be
integrated with data obtained from saliva in children to identify network models and
predictors of primary prevention outcomes. Also, RNA data will be integrated to identify the
genetic, genomic and molecular signature of favorable vs. poor responders to lifestyle
intervention; and to identify novel therapeutic and diagnostic targets in network models of
early atherothrombotic disease.

Aim 3 - Sustainability: To evaluate the sustainability of the impact of the two intensive
lifestyle interventions on healthy behaviors and biological parameters approximately 12
months after the intervention program ends.

Hypothesis: Adult caregivers receiving the intensive lifestyle approaches program, will
maintain sustainability with an advantage of the two "Intensive Interventional groups" over
the control "Traditional Health Education" group. All participants will be followed for
approximately 12 months after the end of the intervention period and reassess their
Fuster-BEWAT Score.

Inclusion Criteria:

Parents and caretakers of children attending 15 preschools that will be comparable in
characteristics related to socio-economic level and ethnicity.

- The schools must be located in Harlem, NY.

- The schools must be public.

- The schools must have children 3, 4 and 5 years of age.

- The schools must provide meals for the children.

- The schools must make available use of their applicable program operation space.

Adult parents and/or caregivers of children enrolled in the FAMILIA children's study will
be approached for participation in this study.

Exclusion Criteria:

- Participation in any other major structured health intervention program similar to the
FAMILIA Program during the evaluation of the program.

- Inability to carry out all activities proposed by the FAMILIA Program.