Health Promotion in Adolescents in Ecuador (ACTIVITAL)
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
Ecuador
Study Type
Interventional
Intervention
Experimental
Sponsored by
About this trial
This is an interventional health services research trial for Overweight focused on measuring Promoting healthy lifestyles in adolescents in Ecuador to prevent overweight
Eligibility Criteria
Inclusion Criteria:
- 11-13 years old
- school-going
- willing to participate
Exclusion Criteria:
- pregnant
- severe medical/physical disorder
Sites / Locations
- Cuenca University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Environmental- and individual based components carried out in the school.
No intervention
Outcomes
Primary Outcome Measures
Behavioural determinants of physical activity and nutrition by determinant questionnaire
Physical activity, physical fitness and sedentarity (questionnaire and accelerometer)
Food intake by 24h recall
Secondary Outcome Measures
Anthropometry
Blood pressure
Socio-economical questionnaire
Full Information
NCT ID
NCT01004367
First Posted
October 28, 2009
Last Updated
November 18, 2021
Sponsor
University Ghent
Collaborators
Institute of Tropical Medicine, Belgium, Nutrition Third World, Belgium, VLIR-IUC, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT01004367
Brief Title
Health Promotion in Adolescents in Ecuador
Acronym
ACTIVITAL
Official Title
ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Institute of Tropical Medicine, Belgium, Nutrition Third World, Belgium, VLIR-IUC, Belgium
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Promoting healthy lifestyles in adolescents in Ecuador to prevent overweight
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Environmental- and individual based components carried out in the school.
Arm Title
2
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Experimental
Intervention Description
Environmental- and individual based components carried out in the school.
Primary Outcome Measure Information:
Title
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
Title
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
Title
Food intake by 24h recall
Time Frame
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Secondary Outcome Measure Information:
Title
Anthropometry
Time Frame
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Title
Blood pressure
Time Frame
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
Title
Socio-economical questionnaire
Time Frame
at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
11-13 years old
school-going
willing to participate
Exclusion Criteria:
pregnant
severe medical/physical disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Kolsteren, MD, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cuenca University
City
Cuenca
Country
Ecuador
12. IPD Sharing Statement
Citations:
PubMed Identifier
29228946
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.
Results Reference
derived
PubMed Identifier
27102653
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.
Results Reference
derived
PubMed Identifier
26395439
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.
Results Reference
derived
PubMed Identifier
25490946
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.
Results Reference
derived
Learn more about this trial
Health Promotion in Adolescents in Ecuador
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