Cuenca University
Cuenca, Ecuador
NCT Number: NCT01004367
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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Notify Me11 year–13 year
All sexes
Interventional
Not applicable
Cuenca, Ecuador
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Environmental- and individual based components carried out in the school.
Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Time frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
University Ghent
Other
ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.
Acronym: ACTIVITAL
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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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