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

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ClinicalTrials.gov Identifier: NCT02481401
Recruitment Status : Active, not recruiting
First Posted : June 25, 2015
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

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.


Condition or disease Intervention/treatment Phase
Promoting Cardiovascular Health in Adults Lifestyle Intervention Atherosclerosis Behavioral: Intensive Individual Intervention Program Behavioral: Peer-To-Peer Program Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 635 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health
Study Start Date : November 2015
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
No Intervention: Control Arm
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.
Experimental: Intensive Individual Intervention Program
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
Active Comparator: Peer-To-Peer Program Intervention
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



Primary Outcome Measures :
  1. Change in Fuster-BEWAT Score [ Time Frame: baseline and 12 months ]
    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.


Secondary Outcome Measures :
  1. Change in Fuster-BEWAT Score [ Time Frame: Baseline and 24 months ]
    BEWAT stands for Blood pressure, Exercise, Weight, Alimentation (diet) and Tobacco (smoking). The overall BEWAT scale ranges from 0 (poor health) to 15 (ideal cardiovascular health). Higher score indicates healthier outcomes.

  2. Change in individual domains assimilated in the composite Fuster-BEWAT Score [ Time Frame: Baseline and 12 months ]
    BEWAT stands for Blood pressure, Exercise, Weight, Alimentation (diet) and Tobacco (smoking). The individual domain score for physical activity (range 0-3), fruit and vegetable consumption (range 0-3), body-mass index (range BMI) (0-3), smoking habits (range 0-3), and blood pressure (range 0-3). Higher score indicates healthier outcomes.

  3. Change in individual domains assimilated in the composite Fuster-BEWAT Score [ Time Frame: Baseline and 24 months ]
    BEWAT stands for Blood pressure, Exercise, Weight, Alimentation (diet) and Tobacco (smoking). The individual domain score for physical activity (range 0-3), fruit and vegetable consumption (range 0-3), body-mass index (range BMI) (0-3), smoking habits (range 0-3), and blood pressure (range 0-3). Higher score indicates healthier outcomes.

  4. Change in Blood Pressure [ Time Frame: baseline and 12 months ]
    Change in blood pressure at 12 months as compared to baseline

  5. Change in Blood Pressure [ Time Frame: baseline and 24 months ]
    Change in blood pressure at 24 months as compared to baseline

  6. Change in IPAQ [ Time Frame: baseline and 12 months ]
    International Physical Activity Questionnaire (IPAQ). Change in IPAQ at 12 months as compared to baseline. It is measured as a continuous variable based on length of time. and expressed as MET-min per week: MET level x minutes of activity x events per week.

  7. Change in IPAQ [ Time Frame: baseline and 24 months ]
    Change in IPAQ scale at 24 months as compared to baseline. IPAQ stands for International Physical Activity Questionnaire. It is measured as a continuous variable based on length of time. and expressed as MET-min per week: MET level x minutes of activity x events per week.

  8. Change in plaque volume [ Time Frame: baseline and 12 months ]
    Change in plaque volume at 12 months as compared to baseline

  9. Change in blood lipid profile [ Time Frame: baseline and 12 months ]
    Change in blood lipid profile at 12 as compared to baseline.

  10. Change in blood lipid profile [ Time Frame: baseline and 24 months ]
    Change in blood lipid profile at 24 months as compared to baseline.

  11. Change in blood glucose [ Time Frame: baseline and 12 months ]
    Change in blood glucose at 12 months as compared to baseline.

  12. Change in blood glucose [ Time Frame: baseline and 24 months ]
    Change in blood glucose at 24 months as compared to baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481401


Locations
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United States, New York
Lutheran Social Services, Site 14
New York, New York, United States, 10027
West Harlem Community Organization, Inc.
New York, New York, United States, 10027
East Harlem Community Organization, Inc., Site 2
New York, New York, United States, 10029
East Harlem Council for Human Services, Inc., Site 1
New York, New York, United States, 10029
Union Settlement Carver Childcare Center
New York, New York, United States, 10029
Union Settlement Head Start at Franklin Plaza
New York, New York, United States, 10029
Union Settlement Johnson
New York, New York, United States, 10029
Union Settlement Leggett Memorial
New York, New York, United States, 10029
Union Settlement Washington
New York, New York, United States, 10029
Addie Mae Collins Head Start, Site 1
New York, New York, United States, 10035
Addie Mae Collins Head Start, Site 2
New York, New York, United States, 10035
Addie Mae Collins Head Start, Site 3
New York, New York, United States, 10035
Association to Benefit Children Graham School
New York, New York, United States, 10035
Lutheran Social Services, Site 11
New York, New York, United States, 10039
Lutheran Social Services, Site 12
New York, New York, United States, 10039
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
American Heart Association
Investigators
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Study Director: Valentin Fuster, MD, PhD Icahn School of Medicine at Mount Sinai
Principal Investigator: Zahi Fayad, PhD Icahn School of Medicine at Mount Sinai

Publications:
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02481401     History of Changes
Other Study ID Numbers: GCO 14-0256 Project 2
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
cardiovascular health
behavior change
community-based
family-based
prevention

Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases