Promoting Heart Health in Preschool Children

Cardiovascular Health Clinical Trial

Official title:

Evaluation of an Intervention to Promote Healthy Heart Habits in Pre-School Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551355
• Other study ID #: GCO 09-0702
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2012
• Last updated: March 7, 2012
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: March 2012
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: Columbia: Foundation Cardio-Infantil Bogota Columbia
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1216
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 5 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Cardiovascular Health

Intervention

Behavioral:
• children - sesame street story book
children - sesame street story book
• children - education imparted by teachers
children - education imparted by teachers
• teachers - sesame street story books
teachers - sesame street books

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Valentin Fuster	Foundation Cardio Infantil, Icahn School of Medicine at Mount Sinai, Sesame Workshop

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	KAH score	Change in Weighted knowledge, attitude, habit (KAH) score among children after 5 months of intervention as compared to prior to intervention.	at baseline and at 5 months	No
Secondary	KAH score for parents	Change in Weighted knowledge, attitude, habit (KAH) score among parents after 5 months of intervention as compared to prior to intervention.	at baseline and at 5 months	No
Secondary	KAH score for teachers	Change in Weighted knowledge, attitude, habit (KAH) score among teachers after 5 months of intervention as compared to prior to intervention.	at baseline and at 5 months	No
Secondary	Body-mass index	Change in body-mass index (z-scores) among children after 5 months of intervention as compared to prior to intervention.	at baseline and at 5 months	No