Health Promotion in Adolescents in Ecuador (ACTIVITAL)
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|ClinicalTrials.gov Identifier: NCT01004367|
Recruitment Status : Unknown
Verified June 2015 by University Ghent.
Recruitment status was: Recruiting
First Posted : October 29, 2009
Last Update Posted : June 4, 2015
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:
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Overweight||Other: Experimental Other: No intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Environmental- and individual based components carried out in the school.
Environmental- and individual based components carried out in the school.Other: No intervention
No intervention carried out in the school
- 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 ]
- 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 ]
- Food intake by 24h recall [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ]
- Anthropometry [ Time Frame: 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 ]
- Socio-economical questionnaire [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004367
|Contact: Patrick Kolsteren, MD, PhDfirstname.lastname@example.org|
|Contact: Roosmarijn Verstraetenemail@example.com|
|Contact: Rosendo Rojas|
|Principal Investigator: Rosendo Rojas|
|Principal Investigator:||Patrick Kolsteren, MD, PhD||University Ghent|