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CompletedNCT02451410Updated Nov 1, 2017

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

An interventional study of Nutrition and physical activity in Obesity, Overweight and Underweight, sponsored by Universidad de Cuenca. Completed at 9 sites in Ecuador. Open to participants aged 3 Years to 4 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-01.

Sponsored by Universidad de Cuenca · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
307
Ages
3 Years to 4 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Overweight
  • Underweight

Keywords

  • Nutrition
  • Physical activity
  • Overweight
  • Obesity
  • Malnutrition
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 307 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Universidad de Cuenca is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 4 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Any child attending a preschool of the municipality

Exclusion criteria

Exclusion Criteria:

Any child whose parents decline inclusion in the study

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
307 participants (actual)

Study arms

  • 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

Interventions

  • OtherNutrition 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).

  2. 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.

    Time frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).

  3. 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.

    Time frame: Changes over 1 year (with 30-day recall). Assessment pre/post intervention (approx 9 months in between).

Secondary outcomes

  1. Nutritional status

    Changes assessed using anthropometry

    Time frame: 1 year. Assessment pre/post intervention (approx 9 months in between).

07

Study locations

9 sites
  • 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, Ecuador
08

References and documents

Publications

  • Abril V, Manuel-y-keenoy B, Sola R, Garcia 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. doi: 10.1177/156482651303400404. PubMed 24605689 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02451410
Lead sponsor
Universidad de Cuenca
Collaborators
Universidad de Antioquia
Responsible party
Victoria Abril (Researcher, Universidad de Cuenca) — Principal investigator
First posted
May 22, 2015
Start date
Sep 2015
Primary completion
Jun 2017
Completion
Jun 2017
Last update
Nov 1, 2017

Study contacts

Victoria Abril, PhD
principal investigator · Universidad de Cuenca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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