Health Promotion in Adolescents in Ecuador (ACTIVITAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Ghent
Sponsor:
Collaborators:
Institute of Tropical Medicine, Belgium
Nutrition Third World
VLIR-IUC, Belgium
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT01004367
First received: October 28, 2009
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention
Overweight
Other: Experimental
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Food intake by 24h recall [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anthropometry [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ] [ Designated as safety issue: No ]
  • Socio-economical questionnaire [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: October 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Environmental- and individual based components carried out in the school.
Other: Experimental
Environmental- and individual based components carried out in the school.
Other: No intervention
No intervention carried out in the school

  Eligibility

Ages Eligible for Study:   11 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant
  • severe medical/physical disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004367

Contacts
Contact: Patrick Kolsteren, MD, PhD patrick.kolsteren@ugent.be
Contact: Roosmarijn Verstraeten roosmarijn.verstraeten@ugent.be

Locations
Ecuador
Cuenca University Recruiting
Cuenca, Ecuador
Contact: Rosendo Rojas         
Principal Investigator: Rosendo Rojas         
Sponsors and Collaborators
University Ghent
Institute of Tropical Medicine, Belgium
Nutrition Third World
VLIR-IUC, Belgium
Investigators
Principal Investigator: Patrick Kolsteren, MD, PhD University Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01004367     History of Changes
Other Study ID Numbers: 2008/462
Study First Received: October 28, 2009
Last Updated: March 7, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Ghent:
Promoting healthy lifestyles in adolescents in Ecuador to prevent overweight

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014