Health Promotion in Adolescents in Ecuador

Study Overview
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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: 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.

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

Conditions
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Overweight

Intervention / Treatment
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* Other: Experimental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 11-13 years old school-going willing to participate Exclusion Criteria: pregnant severe medical/physical disorder

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Environmental- and individual based components carried out in the school. | Other: Experimental<br>* Environmental- and individual based components carried out in the school.<br>|
| No Intervention: 2<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioural determinants of physical activity and nutrition by determinant questionnaire |  | 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) |  | at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention | 
| Food intake by 24h recall |  | at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Promoting healthy lifestyles in adolescents in Ecuador to prevent overweight