Clinical trial NCT02343341: Family-based Approach to Promotion of Health - FAMILIA (Project 1)
Official title: Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health (FAMILIA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Promoting Cardiovascular Health in Younger Age Group
Keywords: early childhood education
cardiovascular health
behavior change
community-based
family-based
prevention
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2015-01-22
Enrollment: 562
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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".

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.

Eligibility criteria: Inclusion Criteria:

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.

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

Primary outcomes:
measure: Change in children's Knowledge, attitude, habit (KAH) scores
timeFrame: baseline and 5 months
Secondary outcomes:
measure: Change in children's BMI Z score, Exercise, and Alimentation (BEA) scores
timeFrame: baseline and 5 months
measure: Change in children's Test of Emotion Comprehension scores
timeFrame: baseline and 5 months
measure: Change in children's Knowledge, attitude, habit (KAH) scores
timeFrame: baseline and 24 months
measure: Change in children's BMI Z score, Exercise, and Alimentation (BEA) scores
timeFrame: baseline and 24 months
measure: Change in children's Test of Emotion Comprehension scores
timeFrame: baseline and 24 months
Other outcomes:
Locations:
city: New York
country: United States
facility: West Harlem Community Organization, Inc.
state: New York
city: New York
country: United States
facility: East Harlem Community Organization, Inc., Site 2
state: New York
city: New York
country: United States
facility: East Harlem Council for Human Services, Inc., Site 1
state: New York
city: New York
country: United States
facility: Union Settlement Carver Childcare Center
state: New York
city: New York
country: United States
facility: Union Settlement Head Start at Franklin Plaza
state: New York
city: New York
country: United States
facility: Union Settlement Johnson
state: New York
city: New York
country: United States
facility: Union Settlement Leggett Memorial
state: New York
city: New York
country: United States
facility: Union Settlement Washington
state: New York
city: New York
country: United States
facility: Addie Mae Collins Head Start, Site 1
state: New York
city: New York
country: United States
facility: Addie Mae Collins Head Start, Site 2
state: New York
city: New York
country: United States
facility: Addie Mae Collins Head Start, Site 3
state: New York
city: New York
country: United States
facility: Association to Benefit Children Graham School
state: New York
city: New York
country: United States
facility: Lutheran Social Services, Site 11
state: New York
city: New York
country: United States
facility: Lutheran Social Services, Site 12
state: New York
city: New York
country: United States
facility: Lutheran Social Services, Site 14
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Valentin Fuster, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.