Family-based Approach to Promotion of Health - FAMILIA (Project 1)
Public ClinicalTrials.gov record NCT02343341. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Family-based Approach in a Minority Community Integrating Systems-Biology for Promotion of Health (FAMILIA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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".
Study identification
- NCT ID
- NCT02343341
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 562 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 3 Years to 5 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2015
- Primary completion
- Aug 31, 2017
- Completion
- Apr 18, 2019
- Last update posted
- May 5, 2019
2015 – 2019
United States locations
- U.S. sites
- 15
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| West Harlem Community Organization, Inc. | New York | New York | 10027 | — |
| East Harlem Community Organization, Inc., Site 2 | New York | New York | 10029 | — |
| East Harlem Council for Human Services, Inc., Site 1 | New York | New York | 10029 | — |
| Union Settlement Carver Childcare Center | New York | New York | 10029 | — |
| Union Settlement Head Start at Franklin Plaza | New York | New York | 10029 | — |
| Union Settlement Johnson | New York | New York | 10029 | — |
| Union Settlement Leggett Memorial | New York | New York | 10029 | — |
| Union Settlement Washington | New York | New York | 10029 | — |
| Addie Mae Collins Head Start, Site 1 | New York | New York | 10035 | — |
| Addie Mae Collins Head Start, Site 2 | New York | New York | 10035 | — |
| Addie Mae Collins Head Start, Site 3 | New York | New York | 10035 | — |
| Association to Benefit Children Graham School | New York | New York | 10035 | — |
| Lutheran Social Services, Site 11 | New York | New York | 10039 | — |
| Lutheran Social Services, Site 12 | New York | New York | 10039 | — |
| Lutheran Social Services, Site 14 | New York | New York | 10039 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02343341, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2019 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02343341 live on ClinicalTrials.gov.