Promoting Consistent Shoe Use Among Children At High Risk for Podoconiosis
Condition: Podoconiosis; Non-Filarial Elephantiasis
MeSH terms: Elephantiasis
Study type: Observational

Summary: 
      Background: Podoconiosis is a debilitating condition affecting one million people in
      Ethiopia. Podoconiosis is preventable if those at genetically high risk consistently
      protected their feet from exposure to silica nanoparticles present in clay soil. Despite the
      efforts of a local Non-Government Organization (NGO) the Mossy Foot Prevention & Treatment
      Association (MFTPA) to distribute shoes to podoconiosis patients and their children, use of
      footwear is intermittent. This protocol proposes a collaboration among faculty from NHGRI,
      Addis Ababa University, and the MFTPA to develop and test intervention approaches that have
      the potential to be sustained by the community, to motivate children from families affected
      by podoconiosis to consistently wear shoes.

      Objective: The three primary aims are to: (1) use qualitative assessment strategies to
      explore factors influencing shoe use among high-risk children; (2) use these findings to
      develop culturally-tailored intervention modules; and (3) evaluate in a randomized trial the
      individual and joint effects of the intervention modules in encouraging high-risk children to
      consistently wear shoes.

      Population: Children (ages 9 -15) from families affected by podoconiosis who are
      participating in shoe distributions in one of 13 communities in the Wolaita zone of Ethiopia
      served by MFTPA.

      Methods: Guided by the PRECEDE-PROCEED approach to planning, implementing and evaluating
      public health programs, a two-phase study is proposed.

      Phase 1 will employ qualitative methods including participant observation, extended case
      studies, key-informant interviews and focus group discussions in a sample of 4 communities to
      gain understanding of the factors that influence shoe wear among high-risk children. Informed
      by these results, content for two modules (an enhanced education module and a role model
      support module) will be developed with the aim to motivate consistent use of footwear.

      Phase 2 will evaluate the individual and joint effectiveness of the two intervention modules
      in a randomized 2 x 2 factorial design with communities assigned randomly to one of 4
      intervention conditions: (GP1) no enhanced health education and no role model support (usual
      care), (GP2) enhanced health education without role model support, (GP3) no enhanced health
      education with role model support, and (GP4) enhanced health education and role model
      support. All children receive shoes. Children will be surveyed at baseline, 3-5 days after
      shoe distribution, and again, 3- and 6- months post baseline.

      Outcomes: The primary outcome is a composite of direct observation of shoe use, self-reported
      shoe use, and baseline-to-follow-up changes in the children s foot appearance based on a
      visual foot exam.

      ...
    

Detailed description: 
      Background: Podoconiosis is a debilitating condition affecting one million people in
      Ethiopia. Podoconiosis is preventable if those at genetically high risk consistently
      protected their feet from exposure to silica nanoparticles present in clay soil. Despite the
      efforts of a local Non-Government Organization (NGO) the Mossy Foot Prevention & Treatment
      Association (MFTPA) to distribute shoes to podoconiosis patients and their children, use of
      footwear is intermittent. This protocol proposes a collaboration among faculty from NHGRI,
      Addis Ababa University, and the MFTPA to develop and test intervention approaches that have
      the potential to be sustained by the community, to motivate children from families affected
      by podoconiosis to consistently wear shoes.

      Objective: The three primary aims are to: (1) use qualitative assessment strategies to
      explore factors influencing shoe use among high-risk children; (2) use these findings to
      develop culturally-tailored intervention modules; and (3) evaluate in a randomized trial the
      individual and joint effects of the intervention modules in encouraging high-risk children to
      consistently wear shoes.

      Population: Children (ages 9 -15) from families affected by podoconiosis who are
      participating in shoe distributions in one of 13 communities in the Wolaita zone of Ethiopia
      served by MFTPA.

      Methods: Guided by the PRECEDE-PROCEED approach to planning, implementing and evaluating
      public health programs, a two-phase study is proposed.

      Phase 1 will employ qualitative methods including participant observation, extended case
      studies, key-informant interviews and focus group discussions in a sample of 4 communities to
      gain understanding of the factors that influence shoe wear among high-risk children. Informed
      by these results, content for two modules (an enhanced education module and a role model
      support module) will be developed with the aim to motivate consistent use of footwear.

      Phase 2 will evaluate the individual and joint effectiveness of the two intervention modules
      in a randomized 2 x 2 factorial design with communities assigned randomly to one of 4
      intervention conditions: (GP1) no enhanced health education and no role model support (usual
      care), (GP2) enhanced health education without role model support, (GP3) no enhanced health
      education with role model support, and (GP4) enhanced health education and role model
      support. All children receive shoes. Children will be surveyed at baseline, 3-5 days after
      shoe distribution, and again, 3- and 6- months post baseline.

      Outcomes: The primary outcome is a composite of direct observation of shoe use, self-reported
      shoe use, and baseline-to-follow-up changes in the children s foot appearance based on a
      visual foot exam.
    

Time perspective: Prospective
Keywords: Podoconiosis; Genetic Education; Primary Prevention; Ethiopa; Youth