Promoting Cardiovascular Health in Younger Age GroupFAMILIANCT02343341

Family-based Approach to Promotion of Health - FAMILIA (Project 1)

A study testing Preschool Health Promotion Education Program in people with Promoting Cardiovascular Health in Younger Age Group, run by Icahn School of Medicine at Mount Sinai at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Problem: Childhood obesity has more than doubled over the past 30 years, with nearly one-third of children aged 6 to 11 years being obese. These children are more likely to become obese adults and are at a higher risk for the development of diabetes, hypertension, heart disease and cancer. Read more about this study

Who is it for?: Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Promoting Cardiovascular Health in Younger Age Group
What is being tested?: Preschool Health Promotion Education Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 562 participants
Where: 15 sitesUnited States
Study dates: Nov 2015to 19 Apr 2019
Phase: Interventional

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 3 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Fifteen preschools comparable in characteristics related to socio-economic level and ethnicity with the following criteria:
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.

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.

City, postcode or hospital

15 sites in 1 country

United States15 sites

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
Lutheran Social Services, Site 14
New York, New York, 10039

Other trials in United States

About this study

Official title: Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health (FAMILIA)

Approach: This research tests the hypothesis that habits are formed very early in life and that children can help their parents live healthier lives. The investigators attempt to test this hypothesis by evaluating the impact of an educational program focusing on diet, physical activity, knowledge of the human body, and management of emotions for preschool children aged 3 to 5 years, their parents/caregivers and teachers. The investigators will first assess the environmental factors, facilitators, and barriers to implementation of a health promotion educational program tailored for preschoolers in Harlem, New York. This information will be used to tailor the educational program for the children in Harlem. The investigators will evaluate the effectiveness of the program in children aged 3 to 5 years by randomly assigning blocks of schools to a 4-month educational and playful health promotion intervention or to usual curriculum. The program will also have components for teachers and parents of these children in order to make their learning environment conducive to positive change. The impact of our program will be assessed on children's knowledge, attitudes, habits, weight, exercise and diet using simple questionnaires and measurements.

Impact: The investigators expect to demonstrate a positive impact on knowledge, attitudes and habits in preschool children in an under-served population. Also aim is to demonstrate that this early educational program can increase the proportion of preschool aged children with normal weight. This approach has the potential to meaningfully modify the projected rise in obesity and cardiovascular disease by affecting an entire generation of children. The investigators believe that the healthy habits that the children will acquire through this program will lead them to be healthier adults. Thus, the mission aligns closely with the American Heart Association's mission of, "Building healthier lives, free of cardiovascular diseases and stroke".

Read the detailed description

Aim 1- Pilot: In the 1-year initial pilot period, the investigators will identify the contextual factors, facilitators and barriers that may impact the implementation of a preschool-based health promotion educational program in Harlem, using qualitative research methods: 1) focus group discussions among teachers; 2) focus group discussions among community leaders; and 3) focus group discussions among parents of preschool-aged children.

Subsidiary Aim 1.1: To use identified facilitators and barriers to develop a contextually and culturally appropriate model for a preschool-based health promotion educational program.

Subsidiary Aim 1.2: To implement a pilot intervention of the contextually and culturally adapted program at two 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.

Aim 2- Randomization: To evaluate the effectiveness of the preschool-based health promotion educational program on KAH-BEA: knowledge (K), attitudes (A), habits (H), BMI Z score (B), exercise (E) and Alimentation (A)(KAH-BEA) of approximately 600 preschool children, using a composite questionnaire-based score (KAH score) measuring the parameters related to the domains of diet, physical activity, health of the body and heart, and management of emotions, and weight and physical activity.

The investigators hypothesize that preschool children receiving the health promotion educational program will demonstrate a higher composite KAH score than controls.

The investigators hypothesize that a higher proportion of preschool children receiving the health promotion educational program will be eutrophic (B) than controls.

The investigators hypothesize that preschool children receiving the health promotion educational program will show higher levels of exercise and physical activity (E) and healthier diets (A) than controls.

For Aim 2, approximately 600 preschool children will be recruited from 15 schools in Harlem, NY, and perform a 3:2 (3 intervention: 2 control) cluster randomization of the schools. The preschool children will receive the intensive educational program for a period of four months. The primary assessments mentioned in Aim 2 will occur at approximately five months. At that time, the control schools will crossover to receive the educational program over the next four months.

Saliva will be collected from all children with assent. Saliva will be used to isolate DNA. The investigators will integrate this information with the one obtained from pre- and post-intervention blood adult samples to identify network models and predictors of primary prevention outcomes.

Aim 3-Sustainability: To evaluate the sustainability of the impact of a preschool-based health promotion educational program on the KAH-BEA of preschool children.

The investigators hypothesize the impact of an up to 4-month health promotion education program on the knowledge, attitudes, health, BMI, exercise level and diet of preschool children will be sustained out to 24 months.

For Aim 3, the preschool children will continue to be follow after all of them have received the educational intervention, up to approximately 24 months. The completion of this project will allow the assessment of effectiveness of multilevel approaches that intervene on children's environments and that aim to alter early life systems will prove to be effective in improving health habits in children and caregivers. The long-term expectation for these interventions is that they will reduce adolescent and adult obesity in these children and lead to improved CVD outcomes.

Conditions: Promoting Cardiovascular Health in Younger Age Group
Being tested: Preschool Health Promotion Education Program
Keywords: early childhood education, cardiovascular health, behavior change, community-based, family-based, prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Preschool Health Promotion Education ProgramBehavioural

Study groups in NCT02343341
Study group	Role	What they receive
Preschool Health Promotion Education Program	Experimental	Children randomized to the intervention arm will receive a 4-month health promotion education program along with their parents/caregivers and teachers. Receives: Behavioral: Preschool Health Promotion Education Program
Control:Standard Curriculum	Other	The Standard curriculum control arm will receive the standard curriculum in their schools. Children randomized to the control arm will receive the health promotion education program for 4 months after the intervention arm has completed it Receives: Behavioral: Preschool Health Promotion Education Program

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in children's Knowledge, attitude, habit (KAH) scores
The mean change in KAH scores at immediate post-intervention (approximately 5 months) as compared to baseline.
Measured: baseline and 5 months

Secondary outcomes (5)

Change in children's BMI Z score, Exercise, and Alimentation (BEA) scores
The mean change in BEA scores at immediate post-intervention (approximately 5 months) as compared to baseline.
Measured: baseline and 5 months
Change in children's Test of Emotion Comprehension scores
The mean change in BEA scores at immediate post-intervention (approximately 5 months) as compared to baseline.
Measured: baseline and 5 months
Change in children's Knowledge, attitude, habit (KAH) scores
The mean change in children's Knowledge, attitude, habit (KAH) scores at approximately 24 months as compared to baseline.
Measured: baseline and 24 months
Change in children's BMI Z score, Exercise, and Alimentation (BEA) scores
The mean change in BEA scores at approximately 24 months as compared to baseline.
Measured: baseline and 24 months
Change in children's Test of Emotion Comprehension scores
The mean change in BEA scores at approximately 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.

Nov 201519 Apr 2019

First posted22 Jan 2015 (estimated)
Study startNov 2015
Primary completionSep 2017
Study completion19 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Promoting Cardiovascular Health in Younger Age GroupStudies 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: Crossover
Masking: None (open label)
Enrolment: 562 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02343341
Sponsor's protocol ID: GCO 14-0256 Project 1
Acronym: FAMILIA
Status last verified: May 2019
First submitted: 15 Jan 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 27056780
Bansilal 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 28454800
Santos-Beneit G, Fernandez-Jimenez R, de Cos-Gandoy A, Bodega P, Diaz-Munoz R, Hill CA, Turco A, Santana M, Jaslow R, Peyra C, Carvajal I, Fuster V. Performance of Control Groups in Early Childhood Health Promotion Trials: Insights From the SI! Program. J Am Coll Cardiol. 2022 Aug 9;80(6):649-650. doi: 10.1016/j.jacc.2022.06.004. No abstract available.
PubMed 35926941
Fernandez-Jimenez R, Jaslow R, Bansilal S, Santana M, Diaz-Munoz R, Latina J, Soto AV, Vedanthan R, Al-Kazaz M, Giannarelli C, Kovacic JC, Bagiella E, Kasarskis A, Fayad ZA, Hajjar RJ, Fuster V. Child Health Promotion in Underserved Communities: The FAMILIA Trial. J Am Coll Cardiol. 2019 Apr 30;73(16):2011-2021. doi: 10.1016/j.jacc.2019.01.057.
PubMed 31023422