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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: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02481401 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 635 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
BEWAT stands for Blood pressure, Exercise, Weight, Alimentation (diet) and Tobacco (smoking). Change in Fuster-BEWAT score at 12 months as compared to baseline. The overall BEWAT scale ranges from 0 (poor health) to 15 (ideal cardiovascular health). Higher score indicates healthier outcomes.
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 |
What the finished NCT02481401 record still lists
NCT02481401 is an interventional study that assigns participants to a tested intervention. The registered 635 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Intensive Individual Intervention Program is the first listed.
NCT02481401 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02481401's enrollment target sits among peer trials
635 158th of 2000 higher than 1,843 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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