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OpenTrials
Completed

NCT Number: NCT01004367

Health Promotion in Adolescents in Ecuador

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.

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Key information

Age range

11 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cuenca University

Cuenca, Ecuador

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnant
  • severe medical/physical disorder

Treatment and study plan

Experimental

Other

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

Primary outcomes

  1. 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

  2. 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

  3. Food intake by 24h recall

    Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention

Secondary outcomes

  1. Anthropometry

    Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention

  2. Blood pressure

    Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention

  3. Socio-economical questionnaire

    Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ACTIVITAL

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Oct 29, 2009
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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