NCT02451410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

1.8 years

First QC Date

May 11, 2015

Last Update Submit

October 30, 2017

Conditions

ObesityOverweightUnderweight

Keywords

NutritionPhysical activityOverweightObesityMalnutrition

Outcome Measures

Primary Outcomes (3)

  • 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).

  • 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).

  • 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 Outcomes (1)

  • Nutritional status

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

Study Arms (1)

Nutrition and physical activity

EXPERIMENTAL

This arm includes all preschool classes receiving the educational and behavioral intervention to improve nutrition and physical activity

Other: Nutrition and physical activity

Interventions

Nutrition and physical activityOTHER

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.

Nutrition and physical activity

Eligibility Criteria

Age3 Years - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Any child attending a preschool of the municipality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centro Infantil 12 de Abril

Cuenca, Ecuador

Location

Centro Infantil 27 de Febrero

Cuenca, Ecuador

Location

Centro Infantil 9 de Octubre

Cuenca, Ecuador

Location

Centro Infantil El Arenal

Cuenca, Ecuador

Location

Centro Infantil El Cebollar

Cuenca, Ecuador

Location

Centro Infantil El Condor

Cuenca, Ecuador

Location

Centro Infantil San Blas

Cuenca, Ecuador

Location

Centro Infantil Sol de Talentos

Cuenca, Ecuador

Location

Centro Infantil Totoracocha

Cuenca, Ecuador

Location

Related Publications (1)

  • 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.

    PMID: 24605689BACKGROUND

MeSH Terms

Conditions

ObesityOverweightThinnessMotor ActivityMalnutrition

Interventions

Nutritional StatusExercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Victoria Abril, PhD

    Universidad de Cuenca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 22, 2015

Study Start

September 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

EC(9)