Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Promoting Heart Health in Preschool Children

This study has been completed.
Sponsor:
Collaborators:
Mount Sinai School of Medicine
Foundation Cardio Infantil
Sesame Workshop
Information provided by (Responsible Party):
Valentin Fuster, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01551355
First received: March 5, 2012
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Cardiovascular Health
Behavioral: children - sesame street story book
Behavioral: children - education imparted by teachers
Behavioral: teachers - sesame street story books
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Evaluation of an Intervention to Promote Healthy Heart Habits in Pre-School Children

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • KAH score [ Time Frame: at baseline and at 5 months ] [ Designated as safety issue: No ]
    Change in Weighted knowledge, attitude, habit (KAH) score among children after 5 months of intervention as compared to prior to intervention.


Secondary Outcome Measures:
  • KAH score for parents [ Time Frame: at baseline and at 5 months ] [ Designated as safety issue: No ]
    Change in Weighted knowledge, attitude, habit (KAH) score among parents after 5 months of intervention as compared to prior to intervention.

  • KAH score for teachers [ Time Frame: at baseline and at 5 months ] [ Designated as safety issue: No ]
    Change in Weighted knowledge, attitude, habit (KAH) score among teachers after 5 months of intervention as compared to prior to intervention.

  • Body-mass index [ Time Frame: at baseline and at 5 months ] [ Designated as safety issue: No ]
    Change in body-mass index (z-scores) among children after 5 months of intervention as compared to prior to intervention.


Enrollment: 1216
Study Start Date: July 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: children - sesame street story book Behavioral: children - sesame street story book
children - sesame street story book
Active Comparator: children - education imparted by teachers Behavioral: children - education imparted by teachers
children - education imparted by teachers
Experimental: teachers
for teachers - sesame street posters, DVD, teacher's guide
Behavioral: teachers - sesame street story books
teachers - sesame street books

Detailed Description:

Background Increased levels of risk factors during childhood create an important life-long burden that favors the development of cardiovascular (CVD) disease in adulthood. Epidemiologic studies have demonstrated that cardiovascular disease risk factors are identifiable in childhood and persist through to adulthood. It is unknown whether interventions targeting preschoolers may change knowledge, attitudes and habits (KAH) towards healthy lifestyles and, eventually, reduce the burden of CVD.

The goal of the proposed study is to assess over a five month intervention period, the impact of an educational intervention on preschooler's knowledge of, habits and attitudes towards healthy eating and living an active lifestyle. The impact of the intervention will be also assessed in parents and teachers.

Methods The investigators will conduct a cluster, randomized controlled trial in 1216 pre-school children 3 to 5 years of age, 928 parents, and 120 teachers from 14 preschool facilities in Bogotá, Colombia in a low socioeconomic and underprivileged community. Randomization will occur at the facility level. The intervention will include classroom activities and use of printed material (books, posters, teachers' guides, games) and videos. Meanwhile, children in the control facilities will continue with their usual curriculum. A structured survey will be used at baseline and end of study to evaluate changes in KAH and the authors a priori give differential weights (70-20-10, respectively) to the scores to compose a standardized weighted total score (WTS). The primary outcome will be the change in children's WTS and the secondary outcomes will be the changes in parents' and teachers´ WTS.

Potential Impact of the Trial If found to be effective in improving the short-term changes in knowledge, attitudes and habits, the educational intervention may have the potential to influence the children's' diet and physical activity patterns throughout their lifetimes by early interventions when attitudes and habits are formed. The program also targets parents and teachers who contribute to shape children's attitudes and habits and who are often at high risk for health problems associated with unhealthy diet and limited physical activity themselves. The program aims to empower local partners in the health, education, media and government sectors to build up the capacities to ensure sustainability. If proven efficacious in the short term, further evaluative studies should test the hypothesis that this program will serve as an effective and sustainable model to improve children's health worldwide.

  Eligibility

Ages Eligible for Study:   3 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children attending one of the 14 H.I. in Usaquén
  • Children who are 3, 4, or 5 years of age at the time of the beginning of the intervention

Exclusion Criteria:

  • Unwillingness to provide informed consent
  • Children who have received formal training in healthy habits in nutrition and / or physical activity in the 6 months prior to the start of the follow-up period of the study.
  • Children who plan to receive formal training in healthy habits in nutrition and / or physical activity during the follow-up study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551355

Locations
Colombia
Bogota, Colombia
Sponsors and Collaborators
Valentin Fuster
Mount Sinai School of Medicine
Foundation Cardio Infantil
Sesame Workshop
Investigators
Study Chair: Valentin Fuster, MD, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Valentin Fuster, Physician-in-Chief, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01551355     History of Changes
Other Study ID Numbers: GCO 09-0702
Study First Received: March 5, 2012
Last Updated: March 7, 2012
Health Authority: Columbia: Foundation Cardio-Infantil Bogota Columbia

Keywords provided by Mount Sinai School of Medicine:
behavioral modification
health communication
prevention

ClinicalTrials.gov processed this record on November 27, 2014