Education Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children

This study has been completed.
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01085799
First received: March 10, 2010
Last updated: March 15, 2011
Last verified: March 2011

March 10, 2010
March 15, 2011
April 2010
October 2010   (final data collection date for primary outcome measure)
Soil-transmitted helminth re-infection (Ascaris, Trichuris, or Hookworm). [ Time Frame: 4 months post-deworming ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01085799 on ClinicalTrials.gov Archive Site
  • Absenteeism rate. [ Time Frame: During the first 4 months following deworming ] [ Designated as safety issue: No ]
  • Eggs per grams reduction rate. [ Time Frame: 4 months post-deworming ] [ Designated as safety issue: No ]
  • Weight gain (kg) [ Time Frame: 4 months post-deworming ] [ Designated as safety issue: No ]
  • Height gain (cm) [ Time Frame: 4 months post-deworming ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Education Intervention to Reduce Helminth Infections and Absenteeism in Grade 5 School-children
Effectiveness of a Post-deworming Education Intervention to Reduce Soil-transmitted Helminth Infections and Absenteeism in Grade 5 School-children in a Community of Extreme Poverty, Peruvian Amazon

To efficiently control soil-transmitted helminths (Ascaris, Trichuris, and hookworm), WHO, PAHO, and others recommend the inclusion of an education strategy in school-based deworming programs. However, the effectiveness of such a strategy on the rate of STH re-infection and on education indicators, such as absenteeism, remains to be fully understood. The proposed research aims to evaluate the effectiveness of a post-deworming education intervention targeted to Grade 5 school children enrolled in Belén's schools using a cluster-randomized trial design. Results will be used to inform school-based deworming programs in Peru and other similar endemic areas in Latin America and, indeed, around the world.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Infections
Behavioral: Health Education Intervention
This is a health hygiene education strategy which encourages the pro-active role of both teachers and students and changes in attitudes and practices with the aim of keeping the level of parasite infection low, through increased knowledge.
  • Experimental: Health Education Intervention
    Groups of schools receiving the health education intervention
    Intervention: Behavioral: Health Education Intervention
  • No Intervention: Control Schools - Regular curriculum
    Groups of schools not receiving the health education intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1101
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Girls and boys enrolled in Grade 5 in eligible schools located in the Belén district of Iquitos, Peru. Eligible schools have a minimum of 10 boys and 10 girls enrolled in grade 5.
  • Informed written consent obtained from the parents or legal guardian of the child.
  • Verbal assent from child.

Exclusion Criteria:

  • Parents (or guardians) refusing participation of their child.
  • Child who refuses to participate.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT01085799
GEN-09-214, HOA-80064
No
Theresa W. Gyorkos, PhD, McGill University
McGill University Health Center
Not Provided
Principal Investigator: Theresa W. Gyorkos, PhD McGill University Health Center
Study Director: Martín Casapía, MD, MPH Asociación Civil Selva Amazónica
McGill University Health Center
March 2011

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