An Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador

October 30, 2017 updated by: Victoria Abril, Universidad de Cuenca

Impact of an Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
      • Cuenca, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Any child attending a preschool of the municipality

Exclusion Criteria:

Any child whose parents decline inclusion in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nutrition and physical activity
This arm includes all preschool classes receiving the educational and behavioral intervention to improve nutrition and physical activity
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fruit and vegetable consumption habits
Time Frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
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).
Drinking habits
Time Frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
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).
Screen time habits
Time Frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional status
Time Frame: 1 year. Assessment pre/post intervention (approx 9 months in between).
Changes assessed using anthropometry
1 year. Assessment pre/post intervention (approx 9 months in between).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Cuenca

Collaborators

Universidad de Antioquia

Investigators

  • Principal Investigator: Victoria Abril, PhD, Universidad de Cuenca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 19, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intervention1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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