Health Promotion in Adolescents in Ecuador (ACTIVITAL)

November 18, 2021 updated by: University Ghent

ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.

Worldwide, low-income and middle-income countries are undergoing rapid demographic and nutritional changes. Populations tend to move from their traditional food habits towards dietary patterns characterized by a more energy-dense diet, while urbanization and technology (work, transport) play a role in the reduction of their physical activity. This shift towards energy-dense diets and lower levels of physical activity are key determinants of chronic diseases. Nowadays, childhood overweight and obesity are becoming a major threat to public health all in low-income and middle-income countries. Clearly, not properly addressing this health problem will only aggravate the already enormous impact of chronic diseases on the social and economic development of these countries. This study aims to develop a culturally relevant school-based prevention intervention among Ecuadorian adolescents (11-13 years old) in Cuenca. The intervention will target behavioural nutrition and physical activity. Intervention strategies will be developed based on theoretical behavioural change models integrated in two complementary frameworks, i.e. (i) the Intervention Mapping protocol, and (ii) the Comprehensive Participatory Planning and Evaluation protocol.

The study includes two phases:

  1. A formative research, which will be conducted in order to understand the causality of the school environment and unhealthy eating and low physical activity levels in school-going adolescents, aged 12-13 years old.
  2. A paired, cluster-randomized controlled trial including 1400 adolescents (12-13 years old) from 10 pairs of schools (i.e. clusters). Within each pair of clusters, one cluster will be randomly assigned to the intervention and the other to the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1400

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
        • Cuenca University

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

11 years to 13 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 11-13 years old
  • school-going
  • willing to participate

Exclusion Criteria:

  • pregnant
  • severe medical/physical disorder

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Environmental- and individual based components carried out in the school.
Other: Experimental
Environmental- and individual based components carried out in the school.
NO_INTERVENTION: 2
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Behavioural determinants of physical activity and nutrition by determinant questionnaire
Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Physical activity, physical fitness and sedentarity (questionnaire and accelerometer)
Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Food intake by 24h recall
Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Anthropometry
Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Blood pressure
Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Socio-economical questionnaire
Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention

Collaborators and Investigators

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

Sponsor

University Ghent

Collaborators

Institute of Tropical Medicine, Belgium
Nutrition Third World, Belgium
VLIR-IUC, Belgium

Investigators

  • Principal Investigator: Patrick Kolsteren, MD, PhD, University Ghent

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

October 1, 2009

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (ESTIMATE)

October 29, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/462

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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