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

Completed · Not applicable

Conditions studied: Promoting Cardiovascular Health in Younger Age Group

In brief

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".

Key facts

Study ID

NCT02343341

Run by

Icahn School of Medicine at Mount Sinai

People needed

562

Starts

2015-11-01

Expected to finish

2019-04-19

Last updated by the study team

2019-05-06

Who can join

Age: 3 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• West Harlem Community Organization, Inc. — New York, New York, United States
• East Harlem Community Organization, Inc., Site 2 — New York, New York, United States
• East Harlem Council for Human Services, Inc., Site 1 — New York, New York, United States
• Union Settlement Carver Childcare Center — New York, New York, United States
• Union Settlement Head Start at Franklin Plaza — New York, New York, United States
• Union Settlement Johnson — New York, New York, United States
• Union Settlement Leggett Memorial — New York, New York, United States
• Union Settlement Washington — New York, New York, United States
• Addie Mae Collins Head Start, Site 1 — New York, New York, United States
• Addie Mae Collins Head Start, Site 2 — New York, New York, United States
• Addie Mae Collins Head Start, Site 3 — New York, New York, United States
• Association to Benefit Children Graham School — New York, New York, United States
• Lutheran Social Services, Site 11 — New York, New York, United States
• Lutheran Social Services, Site 12 — New York, New York, United States
• Lutheran Social Services, Site 14 — New York, New York, United States

Full record on ClinicalTrials.gov

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