Family-based Approach to Promotion of Health - FAMILIA (Project 1)
Condition: Promoting Cardiovascular Health in Younger Age Group
Study type: Interventional

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.
    

Intervention name(s): Preschool Health Promotion Education Program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: early childhood education; cardiovascular health; behavior change; community-based; family-based; prevention