Brief 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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

635

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach

1 country

15 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

First Submitted

Initial submission to the registry

June 23, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed

4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2019

Completed

Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

2.6 years

First QC Date

June 23, 2015

Last Update Submit

May 2, 2019

Conditions

Promoting Cardiovascular Health in Adults Lifestyle Intervention Atherosclerosis

Keywords

cardiovascular healthbehavior changecommunity-basedfamily-basedprevention

Outcome Measures

Primary Outcomes (1)

Change in Fuster-BEWAT Score
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.
baseline and 12 months

Secondary Outcomes (12)

Change in Fuster-BEWAT Score
Baseline and 24 months
Change in individual domains assimilated in the composite Fuster-BEWAT Score
Baseline and 12 months
Change in individual domains assimilated in the composite Fuster-BEWAT Score
Baseline and 24 months
Change in Blood Pressure
baseline and 12 months
Change in Blood Pressure
baseline and 24 months
+7 more secondary outcomes

Study Arms (3)

Control Arm

NO INTERVENTION

Will not receive any structured program except for the health promotion education program that the children will receive for 4 months. Complementary to the Si! Program. This is essentially healthy habits related information and activities to be performed with their kids through family newsletters. All participants (including controls) have access to the study website for health related information.

Intensive Individual Intervention Program

EXPERIMENTAL

A combination of one-on-one personalized lifestyle counseling (8 months with 4 complimentary sessions for a total of 12 months) and a wearable physical activity monitor such as the Garmin Vivofit.

Behavioral: Intensive Individual Intervention Program

Peer-To-Peer Program Intervention

ACTIVE COMPARATOR

Monthly meetings for 60-90 minutes in groups of about up to 20 supporting each other in self-control of CV risk factors, for a total of 12 months.

Behavioral: Peer-To-Peer Program Intervention

Interventions

Intensive Individual Intervention ProgramBEHAVIORAL

Intensive Individual Intervention Program

Peer-To-Peer Program InterventionBEHAVIORAL

Peer-To-Peer Program Intervention

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Icahn School of Medicine at Mount Sinailead
American Heart Associationcollaborator

Study Sites (15)

Lutheran Social Services, Site 14

New York, New York, 10027, United States

Location

West Harlem Community Organization, Inc.

New York, New York, 10027, United States

Location

East Harlem Community Organization, Inc., Site 2