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Health Promotion in Adolescents in Ecuador

NCT ID: NCT01004367

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight

Keywords

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Promoting healthy lifestyles in adolescents in Ecuador to prevent overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Environmental- and individual based components carried out in the school.

Group Type EXPERIMENTAL

Experimental

Intervention Type OTHER

Environmental- and individual based components carried out in the school.

2

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental

Environmental- and individual based components carried out in the school.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnant
* severe medical/physical disorder
Minimum Eligible Age

11 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role collaborator

Nutrition Third World, Belgium

OTHER

Sponsor Role collaborator

VLIR-IUC, Belgium

UNKNOWN

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Kolsteren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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Cuenca University

Cuenca, , Ecuador

Site Status

Countries

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Ecuador

References

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Ochoa-Aviles A, Verstraeten R, Huybregts L, Andrade S, Van Camp J, Donoso S, Ramirez PL, Lachat C, Maes L, Kolsteren P. A school-based intervention improved dietary intake outcomes and reduced waist circumference in adolescents: a cluster randomized controlled trial. Nutr J. 2017 Dec 11;16(1):79. doi: 10.1186/s12937-017-0299-5.

Reference Type DERIVED
PMID: 29228946 (View on PubMed)

Andrade S, Lachat C, Cardon G, Ochoa-Aviles A, Verstraeten R, Van Camp J, Ortiz J, Ramirez P, Donoso S, Kolsteren P. Two years of school-based intervention program could improve the physical fitness among Ecuadorian adolescents at health risk: subgroups analysis from a cluster-randomized trial. BMC Pediatr. 2016 Apr 22;16:51. doi: 10.1186/s12887-016-0588-8.

Reference Type DERIVED
PMID: 27102653 (View on PubMed)

Andrade S, Verloigne M, Cardon G, Kolsteren P, Ochoa-Aviles A, Verstraeten R, Donoso S, Lachat C. School-based intervention on healthy behaviour among Ecuadorian adolescents: effect of a cluster-randomized controlled trial on screen-time. BMC Public Health. 2015 Sep 22;15:942. doi: 10.1186/s12889-015-2274-4.

Reference Type DERIVED
PMID: 26395439 (View on PubMed)

Andrade S, Lachat C, Ochoa-Aviles A, Verstraeten R, Huybregts L, Roberfroid D, Andrade D, Camp JV, Rojas R, Donoso S, Cardon G, Kolsteren P. A school-based intervention improves physical fitness in Ecuadorian adolescents: a cluster-randomized controlled trial. Int J Behav Nutr Phys Act. 2014 Dec 10;11:153. doi: 10.1186/s12966-014-0153-5.

Reference Type DERIVED
PMID: 25490946 (View on PubMed)

Other Identifiers

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2008/462

Identifier Type: -

Identifier Source: org_study_id