Promoting Cardiovascular Health in AdultsFAMILIANCT02481401
Family-based Approach to Promotion of Health - FAMILIA (Project 2)
A study testing Intensive Individual Intervention Program and Peer-To-Peer Program Intervention in people with Promoting Cardiovascular Health in Adults and Lifestyle Intervention, run by Icahn School of Medicine at Mount Sinai at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Promoting Cardiovascular Health in Adults, Lifestyle Intervention, Atherosclerosis
- What is being tested?
- Intensive Individual Intervention Program and Peer-To-Peer Program Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 635 participants
- Where
- 15 sitesUnited States
- Study dates
- Nov 2015to 19 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
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
About this study
Official title: Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health
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.
Read the detailed description
Aim 1 - Pilot: To 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: 1) focus group discussions among a representative cohort of adults; 2) focus group discussions among community leaders; and 3) Pilot studies of feasibility of interventions in the representative cohort of adults.
Subsidiary Aim 1.1: To use identified facilitators and barriers to develop a contextually and culturally appropriate model for an adult lifestyle intervention program.
Subsidiary Aim 1.2: To implement a pilot intervention of the contextually and culturally adapted program among a sample of parents/caregivers of children in preschools in Harlem.
The investigators will assess for acceptability and feasibility, and make any necessary modifications prior to the implementation of the cluster-randomized trial. This aim will be carried out at 2 preschools in Harlem, NY by including the parents and caregivers of pre-school children. The final intervention program that results from this intervention-mapping program will be piloted in parent groups of 8-10.
Aim 2 - Randomization: To determine (i) the impact of two intensive lifestyle interventions on promoting and improving healthy behaviors (increased physical activity, smoking cessation etc.) and biological parameters (lipids, sugar) to lower cardiovascular risk, (ii) the impact of the presence of atherosclerosis on health behaviors and (iii) the impact of the lifestyle interventions on atherosclerosis among approximately 600 asymptomatic at-risk adults.
Hypothesis: Adults receiving the lifestyle intervention programs will demonstrate a greater improvement in healthy behaviors and biological parameters compared to controls.
Hypothesis: Knowledge of presence of atherosclerosis as defined by three-dimensional vascular ultrasound will lead to greater improvement in healthy behaviors.
Hypothesis: Adults receiving the lifestyle intervention programs will demonstrate a lesser progression or regression of three-dimensional vascular ultrasound quantified atherosclerosis compared to controls.
For this aim, the investigators will recruit parents and caregivers of pre-school children from up to twenty schools in Harlem, NY and perform a 3:2 (3 intervention, 2 control) cluster randomization of the schools. Those schools in the "intensive intervention" group will be randomly assigned to one of two interventions- an Intensive Individual Intervention Program" (IIIP) developed through the intervention mapping program described in aim 1 or 'Peer-To-Peer Program - Intervention" (PPPI), refined during that same pilot phase. The primary outcome will be a composite score consisting of a 0-3 scale for behaviors/outcomes related to Blood pressure, Exercise, Weight, Alimentation (diet) and Tobacco (smoking) [Fuster-BEWAT score]. Primary assessments will be performed at baseline, at the end of the intervention (approximately 12 months, peak effect), and at approximately 24 months (sustainability). The 12 month assessment will be used to calculate the between group difference for the change in the Fuster-BEWAT score and will be the primary outcome measure for the adults. To evaluate the sustainability of the impact of the two intensive lifestyle interventions on healthy behaviors and biological parameters 12 months after the intervention program ends. For the assessment of secondary outcome measures, participants will undergo point of care testing for a lipid panel and blood sugar assessment, and a three-dimensional vascular ultrasound (carotid, ileo-femoral) to assess for presence and extent of atherosclerosis at baseline and after the intervention period.
Blood will be collected from all adults who provide consent at enrollment and at the end of the intervention period. Blood from adults will be used to isolate DNA and plasma. In addition, by in vitro culture of blood-derived mononuclear cells, we will derive macrophages, which will then be driven to become foam cells. RNA will be isolated from pre- and post-intervention blood samples. Genomic data obtained from adult blood samples will be integrated with data obtained from saliva in children to identify network models and predictors of primary prevention outcomes. Also, RNA data will be integrated to identify the genetic, genomic and molecular signature of favorable vs. poor responders to lifestyle intervention; and to identify novel therapeutic and diagnostic targets in network models of early atherothrombotic disease.
Aim 3 - Sustainability: To 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.
Hypothesis: Adult caregivers receiving the intensive lifestyle approaches program, will maintain sustainability with an advantage of the two "Intensive Interventional groups" over the control "Traditional Health Education" group. All participants will be followed for approximately 12 months after the end of the intervention period and reassess their Fuster-BEWAT Score.
- Being tested
- Intensive Individual Intervention Program, Peer-To-Peer Program Intervention
- Keywords
- cardiovascular health, behavior change, community-based, family-based, prevention
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Individual Intervention ProgramBehavioural
Peer-To-Peer Program InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Peer-To-Peer Program Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 12 months
Secondary outcomes (12)
Change in Fuster-BEWAT Score
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.
Measured: Baseline and 24 months
Change in individual domains assimilated in the composite Fuster-BEWAT Score
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.
Measured: Baseline and 12 months
Change in individual domains assimilated in the composite Fuster-BEWAT Score
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.
Measured: Baseline and 24 months
Change in Blood Pressure
Change in blood pressure at 12 months as compared to baseline
Measured: baseline and 12 months
Change in Blood Pressure
Change in blood pressure at 24 months as compared to baseline
Measured: baseline and 24 months
Change in IPAQ
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.
Measured: baseline and 12 months
Change in IPAQ
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.
Measured: baseline and 24 months
Change in plaque volume
Change in plaque volume at 12 months as compared to baseline
Measured: baseline and 12 months
Change in blood lipid profile
Change in blood lipid profile at 12 as compared to baseline.
Measured: baseline and 12 months
Change in blood lipid profile
Change in blood lipid profile at 24 months as compared to baseline.
Measured: baseline and 24 months
Change in blood glucose
Change in blood glucose at 12 months as compared to baseline.
Measured: baseline and 12 months
Change in blood glucose
Change in blood glucose at 24 months as compared to baseline.
Measured: baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2018
- Study completion19 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Promoting Cardiovascular Health in AdultsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 635 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Valentin Fuster, MD, PhD, Study director, Icahn School of Medicine at Mount SinaiZahi Fayad, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481401
- Sponsor's protocol ID
- GCO 14-0256 Project 2
- Acronym
- FAMILIA
- Status last verified
- May 2019
- First submitted
- 23 Jun 2015
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vedanthan R, Bansilal S, Soto AV, Kovacic JC, Latina J, Jaslow R, Santana M, Gorga E, Kasarskis A, Hajjar R, Schadt EE, Bjorkegren JL, Fayad ZA, Fuster V. Family-Based Approaches to Cardiovascular Health Promotion. J Am Coll Cardiol. 2016 Apr 12;67(14):1725-37. doi: 10.1016/j.jacc.2016.01.036.
PubMed 27056780Bansilal S, Vedanthan R, Kovacic JC, Soto AV, Latina J, Bjorkegren JLM, Jaslow R, Santana M, Sartori S, Giannarelli C, Mani V, Hajjar R, Schadt E, Kasarskis A, Fayad ZA, Fuster V. Rationale and Design of Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health (FAMILIA). Am Heart J. 2017 May;187:170-181. doi: 10.1016/j.ahj.2017.02.020. Epub 2017 Feb 22.
PubMed 28454800Iglesies-Grau J, Fernandez-Jimenez R, Diaz-Munoz R, Jaslow R, de Cos-Gandoy A, Santos-Beneit G, Hill CA, Turco A, Kadian-Dodov D, Kovacic JC, Fayad ZA, Fuster V. Subclinical Atherosclerosis in Young, Socioeconomically Vulnerable Hispanic and Non-Hispanic Black Adults. J Am Coll Cardiol. 2022 Jul 19;80(3):219-229. doi: 10.1016/j.jacc.2022.04.054.
PubMed 35835495
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health
- ClinicalTrials.gov ID
- NCT02481401
- Acronym / sponsor ID
- FAMILIA / GCO 14-0256 Project 2
- Keywords
- cardiovascular health, behavior change, community-based, family-based, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 635 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Nov 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim 1 - Pilot: To 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: 1) focus group discussions among a representative cohort of adults; 2) focus group discussions among community leaders; and 3) Pilot studies of feasibility of interventions in the representative cohort of adults.
Subsidiary Aim 1.1: To use identified facilitators and barriers to develop a contextually and culturally appropriate model for an adult lifestyle intervention program.
Subsidiary Aim 1.2: To implement a pilot intervention of the contextually and culturally adapted program among a sample of parents/caregivers of children in preschools in Harlem.
The investigators will assess for acceptability and feasibility, and make any necessary modifications prior to the implementation of the cluster-randomized trial. This aim will be carried out at 2 preschools in Harlem, NY by including the parents and caregivers of pre-school children. The final intervention program that results from this intervention-mapping program will be piloted in parent groups of 8-10.
Aim 2 - Randomization: To determine (i) the impact of two intensive lifestyle interventions on promoting and improving healthy behaviors (increased physical activity, smoking cessation etc.) and biological parameters (lipids, sugar) to lower cardiovascular risk, (ii) the impact of the presence of atherosclerosis on health behaviors and (iii) the impact of the lifestyle interventions on atherosclerosis among approximately 600 asymptomatic at-risk adults.
Hypothesis: Adults receiving the lifestyle intervention programs will demonstrate a greater improvement in healthy behaviors and biological parameters compared to controls.
Hypothesis: Knowledge of presence of atherosclerosis as defined by three-dimensional vascular ultrasound will lead to greater improvement in healthy behaviors.
Hypothesis: Adults receiving the lifestyle intervention programs will demonstrate a lesser progression or regression of three-dimensional vascular ultrasound quantified atherosclerosis compared to controls.
For this aim, the investigators will recruit parents and caregivers of pre-school children from up to twenty schools in Harlem, NY and perform a 3:2 (3 intervention, 2 control) cluster randomization of the schools. Those schools in the "intensive intervention" group will be randomly assigned to one of two interventions- an Intensive Individual Intervention Program" (IIIP) developed through the intervention mapping program described in aim 1 or 'Peer-To-Peer Program - Intervention" (PPPI), refined during that same pilot phase. The primary outcome will be a composite score consisting of a 0-3 scale for behaviors/outcomes related to Blood pressure, Exercise, Weight, Alimentation (diet) and Tobacco (smoking) [Fuster-BEWAT score]. Primary assessments will be performed at baseline, at the end of the intervention (approximately 12 months, peak effect), and at approximately 24 months (sustainability). The 12 month assessment will be used to calculate the between group difference for the change in the Fuster-BEWAT score and will be the primary outcome measure for the adults. To evaluate the sustainability of the impact of the two intensive lifestyle interventions on healthy behaviors and biological parameters 12 months after the intervention program ends. For the assessment of secondary outcome measures, participants will undergo point of care testing for a lipid panel and blood sugar assessment, and a three-dimensional vascular ultrasound (carotid, ileo-femoral) to assess for presence and extent of atherosclerosis at baseline and after the intervention period.
Blood will be collected from all adults who provide consent at enrollment and at the end of the intervention period. Blood from adults will be used to isolate DNA and plasma. In addition, by in vitro culture of blood-derived mononuclear cells, we will derive macrophages, which will then be driven to become foam cells. RNA will be isolated from pre- and post-intervention blood samples. Genomic data obtained from adult blood samples will be integrated with data obtained from saliva in children to identify network models and predictors of primary prevention outcomes. Also, RNA data will be integrated to identify the genetic, genomic and molecular signature of favorable vs. poor responders to lifestyle intervention; and to identify novel therapeutic and diagnostic targets in network models of early atherothrombotic disease.
Aim 3 - Sustainability: To 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.
Hypothesis: Adult caregivers receiving the intensive lifestyle approaches program, will maintain sustainability with an advantage of the two "Intensive Interventional groups" over the control "Traditional Health Education" group. All participants will be followed for approximately 12 months after the end of the intervention period and reassess their Fuster-BEWAT Score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Intensive Individual Intervention ProgramA 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. |
| Peer-To-Peer Program Intervention | Active comparator | Behavioral: Peer-To-Peer Program InterventionMonthly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Individual Intervention Program | Behavioural | Intensive Individual Intervention Program |
| Peer-To-Peer Program Intervention | Behavioural | Peer-To-Peer Program Intervention |
Primary outcome
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.
12 secondary outcomes
Change in Fuster-BEWAT Score
Time frame: Baseline and 24 months
Change in individual domains assimilated in the composite Fuster-BEWAT Score
Time frame: Baseline and 12 months
Change in individual domains assimilated in the composite Fuster-BEWAT Score
Time frame: Baseline and 24 months
Change in Blood Pressure
Time frame: baseline and 12 months
Change in Blood Pressure
Time frame: baseline and 24 months
Change in IPAQ
Time frame: baseline and 12 months
Change in IPAQ
Time frame: baseline and 24 months
Change in plaque volume
Time frame: baseline and 12 months
Change in blood lipid profile
Time frame: baseline and 12 months
Change in blood lipid profile
Time frame: baseline and 24 months
Change in blood glucose
Time frame: baseline and 12 months
Change in blood glucose
Time frame: baseline and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Background: PubMed 27056780Vedanthan R, Bansilal S, Soto AV, Kovacic JC, Latina J, Jaslow R, Santana M, Gorga E, Kasarskis A, Hajjar R, Schadt EE, Bjorkegren JL, Fayad ZA, Fuster V. Family-Based Approaches to Cardiovascular Health Promotion. J Am Coll Cardiol. 2016 Apr 12;67(14):1725-37. doi: 10.1016/j.jacc.2016.01.036.
- Background: PubMed 28454800Bansilal S, Vedanthan R, Kovacic JC, Soto AV, Latina J, Bjorkegren JLM, Jaslow R, Santana M, Sartori S, Giannarelli C, Mani V, Hajjar R, Schadt E, Kasarskis A, Fayad ZA, Fuster V. Rationale and Design of Family-Based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health (FAMILIA). Am Heart J. 2017 May;187:170-181. doi: 10.1016/j.ahj.2017.02.020. Epub 2017 Feb 22.
- Derived from this study: PubMed 35835495Iglesies-Grau J, Fernandez-Jimenez R, Diaz-Munoz R, Jaslow R, de Cos-Gandoy A, Santos-Beneit G, Hill CA, Turco A, Kadian-Dodov D, Kovacic JC, Fayad ZA, Fuster V. Subclinical Atherosclerosis in Young, Socioeconomically Vulnerable Hispanic and Non-Hispanic Black Adults. J Am Coll Cardiol. 2022 Jul 19;80(3):219-229. doi: 10.1016/j.jacc.2022.04.054.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentin Fuster, MD, PhD study director
Icahn School of Medicine at Mount Sinai
Zahi Fayad, PhD principal investigator
Icahn School of Medicine at Mount Sinai
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Individual Intervention Program and Peer-To-Peer Program Intervention in people with Promoting Cardiovascular Health in Adults and Lifestyle Intervention, run by Icahn School of Medicine at Mount Sinai at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fuster-BEWAT Score (time frame: baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481401, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.