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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT02343341

Collaborator

American Heart Association (Other)

562

Enrollment

Locations

Arms

41.6

Actual Duration (Months)

37.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Promoting Cardiovascular Health in Younger Age Group	Behavioral: Preschool Health Promotion Education Program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

562 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Apr 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Preschool Health Promotion Education Program
Other: 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	Behavioral: Preschool Health Promotion Education Program

Arm

Intervention/Treatment

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.

Behavioral: Preschool Health Promotion Education Program

Other: 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

Behavioral: Preschool Health Promotion Education Program

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change in children's BMI Z score, Exercise, and Alimentation (BEA) scores [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 [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 [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 [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 [baseline and 24 months]
The mean change in BEA scores at approximately 24 months as compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Harlem Community Organization, Inc.	New York	New York	United States	10027
2	East Harlem Community Organization, Inc., Site 2	New York	New York	United States	10029
3	East Harlem Council for Human Services, Inc., Site 1	New York	New York	United States	10029
4	Union Settlement Carver Childcare Center	New York	New York	United States	10029
5	Union Settlement Head Start at Franklin Plaza	New York	New York	United States	10029
6	Union Settlement Johnson	New York	New York	United States	10029
7	Union Settlement Leggett Memorial	New York	New York	United States	10029
8	Union Settlement Washington	New York	New York	United States	10029
9	Addie Mae Collins Head Start, Site 1	New York	New York	United States	10035
10	Addie Mae Collins Head Start, Site 2	New York	New York	United States	10035
11	Addie Mae Collins Head Start, Site 3	New York	New York	United States	10035
12	Association to Benefit Children Graham School	New York	New York	United States	10035
13	Lutheran Social Services, Site 11	New York	New York	United States	10039
14	Lutheran Social Services, Site 12	New York	New York	United States	10039
15	Lutheran Social Services, Site 14	New York	New York	United States	10039