Non-Filarial Elephantiasis Clinical Trial
Official title:
Promoting Consistent Shoe Use Among Children At High Risk for Podoconiosis
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.
...
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01939431 -
Genetic and Other Aspects of Podoconiosis
|