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NCT02481401 · ClinicalTrials.gov registry record · NA
Family-based Approach to Promotion of Health - FAMILIA (Project 2)
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 635
- Enrollment target
NCT02481401 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 635 participants.
The verdict
NCT02481401, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 635 participants
- Enrollment target
Study Summary
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 investi
Interventions
- BEHAVIORAL Intensive Individual Intervention Program
- BEHAVIORAL Peer-To-Peer Program Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 635 participants |
| Start Date | 2015-11 |
| Est. Completion | 2019-04-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02481401
The ClinicalTrials.gov registry entry for NCT02481401 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 635 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intensive Individual Intervention Program is the first listed.
NCT02481401 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02481401 about?
NCT02481401 is a clinical study titled "Family-based Approach to Promotion of Health - FAMILIA (Project 2)". 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 a...
What is the current status of trial NCT02481401?
This trial is currently completed. It is a NA study. The enrollment target is 635 participants. The study started on 2015-11. Estimated completion is 2019-04-19.
What interventions are being tested in trial NCT02481401?
The interventions under investigation include: Intensive Individual Intervention Program (BEHAVIORAL), Peer-To-Peer Program Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT02481401?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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