An Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador
Primary Purpose
Obesity, Overweight, Underweight
Status
Completed
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
Nutrition and physical activity
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Nutrition, Physical activity, Overweight, Obesity, Malnutrition
Eligibility Criteria
Inclusion Criteria:
Any child attending a preschool of the municipality
Exclusion Criteria:
Any child whose parents decline inclusion in the study
Sites / Locations
- Centro Infantil 12 de Abril
- Centro Infantil 27 de Febrero
- Centro Infantil 9 de Octubre
- Centro Infantil El Arenal
- Centro Infantil El Cebollar
- Centro Infantil El Condor
- Centro Infantil San Blas
- Centro Infantil Sol de Talentos
- Centro Infantil Totoracocha
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nutrition and physical activity
Arm Description
This arm includes all preschool classes receiving the educational and behavioral intervention to improve nutrition and physical activity
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Nutritional status
Changes assessed using anthropometry
Full Information
NCT ID
NCT02451410
First Posted
May 11, 2015
Last Updated
October 30, 2017
Sponsor
Universidad de Cuenca
Collaborators
Universidad de Antioquia
1. Study Identification
Unique Protocol Identification Number
NCT02451410
Brief Title
An Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador
Official Title
Impact of an Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Cuenca
Collaborators
Universidad de Antioquia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Underweight
Keywords
Nutrition, Physical activity, Overweight, Obesity, Malnutrition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutrition and physical activity
Arm Type
Experimental
Arm Description
This arm includes all preschool classes receiving the educational and behavioral intervention to improve nutrition and physical activity
Intervention Type
Other
Intervention Name(s)
Nutrition and physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fruit and vegetable consumption habits
Description
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).
Title
Drinking habits
Description
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).
Title
Screen time habits
Description
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 Outcome Measure Information:
Title
Nutritional status
Description
Changes assessed using anthropometry
Time Frame
1 year. Assessment pre/post intervention (approx 9 months in between).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any child attending a preschool of the municipality
Exclusion Criteria:
Any child whose parents decline inclusion in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victoria Abril, PhD
Organizational Affiliation
Universidad de Cuenca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Infantil 12 de Abril
City
Cuenca
Country
Ecuador
Facility Name
Centro Infantil 27 de Febrero
City
Cuenca
Country
Ecuador
Facility Name
Centro Infantil 9 de Octubre
City
Cuenca
Country
Ecuador
Facility Name
Centro Infantil El Arenal
City
Cuenca
Country
Ecuador
Facility Name
Centro Infantil El Cebollar
City
Cuenca
Country
Ecuador
Facility Name
Centro Infantil El Condor
City
Cuenca
Country
Ecuador
Facility Name
Centro Infantil San Blas
City
Cuenca
Country
Ecuador
Facility Name
Centro Infantil Sol de Talentos
City
Cuenca
Country
Ecuador
Facility Name
Centro Infantil Totoracocha
City
Cuenca
Country
Ecuador
12. IPD Sharing Statement
Citations:
PubMed Identifier
24605689
Citation
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.
Results Reference
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An Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador
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