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Health Promotion in Adolescents in Ecuador (ACTIVITAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01004367
Recruitment Status : Unknown
Verified June 2015 by University Ghent.
Recruitment status was:  Recruiting
First Posted : October 29, 2009
Last Update Posted : June 4, 2015
Sponsor:
Collaborators:
Institute of Tropical Medicine, Belgium
Nutrition Third World, Belgium
VLIR-IUC, Belgium
Information provided by (Responsible Party):
University Ghent

Tracking Information
First Submitted Date  ICMJE October 28, 2009
First Posted Date  ICMJE October 29, 2009
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 7, 2013)
  • 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 ]
  • 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 ]
  • Food intake by 24h recall [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • Behavioural determinants of physical activity and nutrition by determinant questionnaire [ Time Frame: at 15 months ]
  • Physical activity, physical fitness and sedentarity (questionnaire and accelerometer) [ Time Frame: at 15 months ]
  • Food intake by 24h recall [ Time Frame: at 15 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2013)
  • Anthropometry [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ]
  • Blood pressure [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ]
  • Socio-economical questionnaire [ Time Frame: at 15 and 24 months, additionally, these will be measured 18 months after completion of the intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • Anthropometry [ Time Frame: at 15 months ]
  • Blood pressure [ Time Frame: at 15 months ]
  • Socio-economical questionnaire [ Time Frame: at 15 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Promotion in Adolescents in Ecuador
Official Title  ICMJE ACTIVITAL: Health Promotion Intervention in Ecuadorian Adolescents to Promote Healthy Dietary and Physical Activity Patterns.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Overweight
Intervention  ICMJE
  • Other: Experimental
    Environmental- and individual based components carried out in the school.
  • Other: No intervention
    No intervention carried out in the school
Study Arms  ICMJE Experimental: 1
Environmental- and individual based components carried out in the school.
Interventions:
  • Other: Experimental
  • Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 28, 2009)
1400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnant
  • severe medical/physical disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ecuador
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004367
Other Study ID Numbers  ICMJE 2008/462
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Ghent
Study Sponsor  ICMJE University Ghent
Collaborators  ICMJE
  • Institute of Tropical Medicine, Belgium
  • Nutrition Third World, Belgium
  • VLIR-IUC, Belgium
Investigators  ICMJE
Principal Investigator: Patrick Kolsteren, MD, PhD University Ghent
PRS Account University Ghent
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP