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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

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : November 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : April 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

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
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343341


Locations
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United States, New York
West Harlem Community Organization, Inc.
New York, New York, United States, 10027
East Harlem Community Organization, Inc., Site 2
New York, New York, United States, 10029
East Harlem Council for Human Services, Inc., Site 1
New York, New York, United States, 10029
Union Settlement Carver Childcare Center
New York, New York, United States, 10029
Union Settlement Head Start at Franklin Plaza
New York, New York, United States, 10029
Union Settlement Johnson
New York, New York, United States, 10029
Union Settlement Leggett Memorial
New York, New York, United States, 10029
Union Settlement Washington
New York, New York, United States, 10029
Addie Mae Collins Head Start, Site 1
New York, New York, United States, 10035
Addie Mae Collins Head Start, Site 2
New York, New York, United States, 10035
Addie Mae Collins Head Start, Site 3
New York, New York, United States, 10035
Association to Benefit Children Graham School
New York, New York, United States, 10035
Lutheran Social Services, Site 11
New York, New York, United States, 10039
Lutheran Social Services, Site 12
New York, New York, United States, 10039
Lutheran Social Services, Site 14
New York, New York, United States, 10039
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
American Heart Association
Investigators
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Principal Investigator: Valentin Fuster, MD, PhD Icahn School of Medicine at Mount Sinai

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02343341    
Other Study ID Numbers: GCO 14-0256 Project 1
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icahn School of Medicine at Mount Sinai:
early childhood education
cardiovascular health
behavior change
community-based
family-based
prevention