Health Promotion in Adolescents in Ecuador

NCT01004367 | Completed

• 1 other identifier: 2008/462
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Overweight

Keywords

Promoting healthy lifestyles in adolescents in Ecuador to prevent overweight

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Other: Experimental

2

NO INTERVENTION

No intervention

Interventions

Experimental OTHER

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

1

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• school-going
• willing to participate

You may not qualify if:

• pregnant
• severe medical/physical disorder

Sponsors & Collaborators

• University Ghent: lead
• Institute of Tropical Medicine, Belgium: collaborator
• Nutrition Third World, Belgium: collaborator
• VLIR-IUC, Belgium: collaborator

Study Sites (1)

Cuenca University

Cuenca, Ecuador

Location

Related Publications (4)

• 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.

  PMID: 29228946 DERIVED

• 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.

  PMID: 27102653 DERIVED

• 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.

  PMID: 26395439 DERIVED

• 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.

  PMID: 25490946 DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Kolsteren, MD, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: October 29, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

EC (1)