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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02451410
Other study ID # Intervention1
Secondary ID
Status Completed
Phase N/A
First received May 11, 2015
Last updated October 30, 2017
Start date September 2015
Est. completion date June 2017

Study information

Verified date October 2017
Source Universidad de Cuenca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to design and evaluate an educational and behavioral intervention focused on improving nutrition and physical activity habits among preschoolers in Cuenca, Ecuador, with the overarching goal of preventing overweight/obesity and promoting the formation of healthy nutrition/physical activity habits.


Description:

In Ecuador and in the city of Cuenca, the prevalence of obesity is high (approximately 22% of the population). Simultaneously, there is high prevalence of chronic malnutrition (e.g., stunting). In a previous study in school-aged children in Cuenca, the prevalence of overweight or obese was 30%.

The objective of this study is to design an intervention to improve nutrition and physical activity habits and behaviors in preschoolers. The study will begin with a baseline survey that will be used to develop the educational and behavioral intervention. The intervention will consist of didactic material for teachers, educational material for parents, and activities for the children. The investigators will carry out the intervention over the course of the school year. The intervention will be primarily delivered in the preschool setting, but will also include workshops for parents.

The investigators hope that this study will help promote the health of children in Cuenca and can be a pilot study to test similar interventions in larger populations in Ecuador.


Recruitment information / eligibility

Status Completed
Enrollment 307
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 4 Years
Eligibility Inclusion Criteria:

Any child attending a preschool of the municipality

Exclusion Criteria:

Any child whose parents decline inclusion in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nutrition and physical activity
The investigators will design an educational and behavioral program focused on health promotion. Didactic material will be developed for teachers and educational material will be developed for parents. For children, the investigators will design educational and playtime materials that encourage healthy eating and physical activity.

Locations

Country Name City State
Ecuador Centro Infantil 12 de Abril Cuenca
Ecuador Centro Infantil 27 de Febrero Cuenca
Ecuador Centro Infantil 9 de Octubre Cuenca
Ecuador Centro Infantil El Arenal Cuenca
Ecuador Centro Infantil El Cebollar Cuenca
Ecuador Centro Infantil El Condor Cuenca
Ecuador Centro Infantil San Blas Cuenca
Ecuador Centro Infantil Sol de Talentos Cuenca
Ecuador Centro Infantil Totoracocha Cuenca

Sponsors (2)

Lead Sponsor Collaborator
Universidad de Cuenca Universidad de Antioquia

Country where clinical trial is conducted

Ecuador, 

References & Publications (1)

Abril V, Manuel-y-keenoy B, Solà R, García JL, Nessier C, Rojas R, Donoso S, Arija V. Prevalence of overweight and obesity among 6-to 9-year-old school children in Cuenca, Ecuador: relationship with physical activity, poverty, and eating habits. Food Nutr Bull. 2013 Dec;34(4):388-401. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fruit and vegetable consumption habits Changes assessed using a pre-/post-intervention questionnaire evaluating the number of days per week fruits/vegetables were consumed as snacks at home. Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
Primary Drinking habits Changes assessed using a pre-/post-intervention questionnaire evaluating the number of days per week water, fruit juices, and soft drinks are consumed at home. Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
Primary Screen time habits Changes assessed using a pre-/post-intervention questionnaire evaluating weekly hours of time spent watching television, using the computer, and playing videogames at home. Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
Secondary Nutritional status Changes assessed using anthropometry 1 year. Assessment pre/post intervention (approx 9 months in between).
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