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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT02481401

Public ClinicalTrials.gov record NCT02481401. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 4:16 PM EDT

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Official title

Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02481401
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
635 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2015
Primary completion
May 31, 2018
Completion
Apr 18, 2019
Last update posted
May 5, 2019

2015 – 2019

United States locations

U.S. sites
15
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Lutheran Social Services, Site 14 New York New York 10027 —
West Harlem Community Organization, Inc. New York New York 10027 —
East Harlem Community Organization, Inc., Site 2 New York New York 10029 —
East Harlem Council for Human Services, Inc., Site 1 New York New York 10029 —
Union Settlement Carver Childcare Center New York New York 10029 —
Union Settlement Head Start at Franklin Plaza New York New York 10029 —
Union Settlement Johnson New York New York 10029 —
Union Settlement Leggett Memorial New York New York 10029 —
Union Settlement Washington New York New York 10029 —
Addie Mae Collins Head Start, Site 1 New York New York 10035 —
Addie Mae Collins Head Start, Site 2 New York New York 10035 —
Addie Mae Collins Head Start, Site 3 New York New York 10035 —
Association to Benefit Children Graham School New York New York 10035 —
Lutheran Social Services, Site 11 New York New York 10039 —
Lutheran Social Services, Site 12 New York New York 10039 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02481401, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 5, 2019 · Synced Sep 6, 2026

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