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

Completed · Not applicable

Conditions studied: Promoting Cardiovascular Health in Adults, Lifestyle Intervention, Atherosclerosis

In brief

Two Intensive Life Style Intervention Programs in Related Caregivers of Preschool Children Substantial strides have been made in the treatment of acute cardiovascular conditions, such as myocardial infarction and stroke, however, the global burden of cardiovascular disease (CVD) continues to rise at an alarming rate. Furthermore, despite the abundant data demonstrating a greater burden of CVD in racial/ethnic minorities, and many specific interventions aimed at changing risk factor patterns or behaviors in racial/ethnic minorities, health disparities persist. In the present study, the investigators seek to evaluate the impact of a multifaceted and comprehensive lifestyle intervention coupled with atherosclerosis imaging on reducing cardiovascular risk among minority adults living in Harlem, New York. The investigators believe that holistic, multi-dimensional individual and peer-to-peer intensive lifestyle interventions involving parents/caregivers of preschool children will be effective in producing favorable change in their behaviors, which will be sustained over time. The primary hypothesis of the study is that aggressive lifestyle interventions will be more effective in improving healthy behaviors and biological correlates in at-risk adult parents and/or caregivers of preschool children in Harlem, NY. In aim 1, as an initial pilot study, the investigators will 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. In aim 2, the investigators will determine the impact of two intensive lifestyle interventions on promoting and improving healthy behaviors and biological parameters to lower cardiovascular risk, the impact of the knowledge of presence of atherosclerosis on health behaviors and the impact of these lifestyle interventions on atherosclerosis among approximately 600 asymptomatic at-risk adults. Finally, in aim 3, the investigators will 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.

Key facts

Study ID

NCT02481401

Run by

Icahn School of Medicine at Mount Sinai

People needed

635

Starts

2015-11-01

Expected to finish

2019-04-19

Last updated by the study team

2019-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Lutheran Social Services, Site 14 — New York, New York, United States
• West Harlem Community Organization, Inc. — New York, New York, United States
• East Harlem Community Organization, Inc., Site 2 — New York, New York, United States
• East Harlem Council for Human Services, Inc., Site 1 — New York, New York, United States
• Union Settlement Carver Childcare Center — New York, New York, United States
• Union Settlement Head Start at Franklin Plaza — New York, New York, United States
• Union Settlement Johnson — New York, New York, United States
• Union Settlement Leggett Memorial — New York, New York, United States
• Union Settlement Washington — New York, New York, United States
• Addie Mae Collins Head Start, Site 1 — New York, New York, United States
• Addie Mae Collins Head Start, Site 2 — New York, New York, United States
• Addie Mae Collins Head Start, Site 3 — New York, New York, United States
• Association to Benefit Children Graham School — New York, New York, United States
• Lutheran Social Services, Site 11 — New York, New York, United States
• Lutheran Social Services, Site 12 — New York, New York, United States

Full record on ClinicalTrials.gov

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