NCT01551355|CompletedPhase 3Results
Promoting Heart Health in Preschool Children
Evaluation of an Intervention to Promote Healthy Heart Habits in Pre-School Children
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Sponsor study identifier
interventional
2,279
1 country
1
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)As part of the Colombian Hearty Health Initiative program led by Mount Sinai Cardiovascular Institute, a multidisciplinary team design and implemented a pedagogic and communication strategies for the promotion of healthy heart habits (PPHH) in preschoolers. This included educational materials, pedagogical activities and the use of Sesame Workshop healthy habits for life materials. For Colombia, the latter were largely developed in collaboration with the Colombian Society of Pediatrics, Colombian Society of Cardiology and Cardiovascular Surgery, Colsubsidio and Fundación Cardioinfantil-Instituto de Cardiología.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 2011
Actual (reported)July 2011
Actual (reported)March 5, 2012
Actual (reported)March 12, 2012
Actual (reported)January 9, 2017
Actual (reported)Change in KAH Score for Children
Change in weighted knowledge, attitude, habit (KAH) (70/20/10) score among children after 5 months of intervention as compared to prior to intervention. The study hypothesized that the mean change in knowledge scores associated with this short intervention period would be larger than the mean changes in scores due to attitudes and habits, differential weights (70, 20, and 10, respectively) were given to the scores a priori to compose a standardized weighted total score (WTS). The developed questionnaires measured knowledge, attitudes, and habits on healthy eating and living an active lifestyle in children, parents, and teachers. Scale range: 0-100 Knowledge scale range: 0-100 Attitude scale range: 0-100 Habit scale range: 0-100 WTS (weighted total score) scale range: 0-100 Higher values represent a better outcome
at baseline and at 6 months
KAH Score for Parents
at baseline and at 6 months
KAH Score for Teachers
at baseline and at 6 months
Body Mass Index - BMI
baseline
The intervened children were provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a "Healthy family day" workshop (1 hour); and weekly health notes. Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children. Teachers also participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received a teacher's guide.
The control preschool facilities continued with their usual preschool curriculum
The intervened children were provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a "Healthy family day" workshop (1 hour); and weekly health notes. Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children. Teachers also participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received a teacher's guide.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Fundación CardioInfantil Instituto de Cardiología
Bogotá, Colombia
minimal participation of teachers in initial planning stage. small number of teachers evaluated has limited the statistical power in this group.
Valentin Fuster, MD, PhD
Icahn School of Medicine at Mount Sinai
2,279 participants (actual enrollment reported by the registry).
First Submitted
March 5, 2012
First Posted
March 12, 2012
Study Start
July 2009
Date type not reportedThis date has not been verified as actual or estimated.
Pilot Study of Oligonol Supplementation to Promote Cardiovascular Health
Contact the study team to confirm eligibility.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
January 9, 2017
Results First Posted
January 9, 2017
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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