Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02343341
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE January 15, 2015
First Posted Date  ICMJE January 22, 2015
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Change in children's Knowledge, attitude, habit (KAH) scores [ Time Frame: baseline and 5 months ]
The mean change in KAH scores at immediate post-intervention (approximately 5 months) as compared to baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
Change in children's Knowledge, attitude, habit (KAH) scores [ Time Frame: baseline and 5 months ]
The mean change in KAH scores at 5 months as compared to baseline.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2018)
  • Change in children's BMI Z score, Exercise, and Alimentation (BEA) scores [ Time Frame: baseline and 5 months ]
    The mean change in BEA scores at immediate post-intervention (approximately 5 months) as compared to baseline.
  • Change in children's Test of Emotion Comprehension scores [ Time Frame: baseline and 5 months ]
    The mean change in BEA scores at immediate post-intervention (approximately 5 months) as compared to baseline.
  • Change in children's Knowledge, attitude, habit (KAH) scores [ Time Frame: baseline and 24 months ]
    The mean change in children's Knowledge, attitude, habit (KAH) scores at approximately 24 months as compared to baseline.
  • Change in children's BMI Z score, Exercise, and Alimentation (BEA) scores [ Time Frame: baseline and 24 months ]
    The mean change in BEA scores at approximately 24 months as compared to baseline.
  • Change in children's Test of Emotion Comprehension scores [ Time Frame: baseline and 24 months ]
    The mean change in BEA scores at approximately 24 months as compared to baseline.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
Change in children's BMI Z score, Exercise, and Alimentation (BEA) scores [ Time Frame: baseline and 36 months ]
The mean change in BEA scores at 36 months as compared to baseline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family-based Approach to Promotion of Health - FAMILIA (Project 1)
Official Title  ICMJE Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health (FAMILIA)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Promoting Cardiovascular Health in Younger Age Group
Intervention  ICMJE Behavioral: Preschool Health Promotion Education Program
Study Arms  ICMJE
  • Experimental: Preschool Health Promotion Education Program
    Children randomized to the intervention arm will receive a 4-month health promotion education program along with their parents/caregivers and teachers.
    Intervention: Behavioral: Preschool Health Promotion Education Program
  • Control:Standard Curriculum

    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

    Intervention: Behavioral: Preschool Health Promotion Education Program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2018)
562
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2015)
600
Actual Study Completion Date  ICMJE April 19, 2019
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02343341
Other Study ID Numbers  ICMJE GCO 14-0256 Project 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE American Heart Association
Investigators  ICMJE
Principal Investigator: Valentin Fuster, MD, PhD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP