Health Promotion in Adolescents in Ecuador

Overweight Clinical Trial

— ACTIVITAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004367
• Other study ID #: 2008/462
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: December 2015

Study information

• Verified date: November 2021
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 13 Years

Eligibility

Inclusion Criteria:

• 11-13 years old

• school-going

• willing to participate

Exclusion Criteria:

• pregnant

• severe medical/physical disorder

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• Experimental
Environmental- and individual based components carried out in the school.

Locations

Country	Name	City	State
Ecuador	Cuenca University	Cuenca

Sponsors (4)

Lead Sponsor	Collaborator
University Ghent	Institute of Tropical Medicine, Belgium, Nutrition Third World, Belgium, VLIR-IUC, Belgium

Country where clinical trial is conducted

Ecuador, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Food intake by 24h recall		at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Secondary	Anthropometry		at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Secondary	Blood pressure		at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Secondary	Socio-economical questionnaire		at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention