Clinical trial NCT01004367: Health Promotion in Adolescents in Ecuador
Official title: ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Promoting healthy lifestyles in adolescents in Ecuador to prevent overweight
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, Belgium
name: Nutrition Third World, Belgium
name: VLIR-IUC, Belgium
First posted: 2009-10-29
Enrollment: 1400
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pregnant
* severe medical/physical disorder

Primary outcomes:
measure: Behavioural determinants of physical activity and nutrition by determinant questionnaire
timeFrame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
measure: Physical activity, physical fitness and sedentarity (questionnaire and accelerometer)
timeFrame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
measure: Food intake by 24h recall
timeFrame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Secondary outcomes:
measure: Anthropometry
timeFrame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
measure: Blood pressure
timeFrame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
measure: Socio-economical questionnaire
timeFrame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Other outcomes:
Locations:
city: Cuenca
country: Ecuador
facility: Cuenca University
Study officials:
affiliation: University Ghent
name: Patrick Kolsteren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.