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NCT02343341 · ClinicalTrials.gov registry record · NA
Family-based Approach to Promotion of Health - FAMILIA (Project 1)
A NA study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- NA
- Development phase
- 562
- Enrollment target
NCT02343341: Completed NA study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02343341 is a NA study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 562 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02343341, a NA study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- NA
- Development phase
- 562 participants
- Enrollment target
Study 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. Th
Primary Outcome
The mean change in KAH scores at immediate post-intervention (approximately 5 months) as compared to baseline.
Interventions
- BEHAVIORAL Preschool Health Promotion Education Program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2015-11 |
| Est. Completion | 2019-04-19 |
| Phase | NA |
What the finished NCT02343341 record still lists
NCT02343341 is an interventional study that assigns participants to a tested intervention. The registered 562 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Preschool Health Promotion Education Program is the first listed.
NCT02343341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02343341 about?
NCT02343341 is a clinical study titled "Family-based Approach to Promotion of Health - FAMILIA (Project 1)". 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...
What is the current status of trial NCT02343341?
This trial is currently completed. It is a NA study. The enrollment target is 562 participants. The study started on 2015-11. Estimated completion is 2019-04-19.
What interventions are being tested in trial NCT02343341?
The interventions under investigation include: Preschool Health Promotion Education Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT02343341?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02343341's enrollment target sits among peer trials
562 181st of 2000 higher than 1,820 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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