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Promoting Consistent Shoe Use Among Children At High Risk for Podoconiosis

2014-07-23 21:08:28 | BioPortfolio

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.

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.

Study Design

Time Perspective: Prospective

Conditions

Podoconiosis

Location

National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda
Maryland
United States
20892

Status

Recruiting

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:28-0400

Clinical Trials [0 Results]

None

PubMed Articles [2 Associated PubMed Articles listed on BioPortfolio]

Global epidemiology of podoconiosis: A systematic review.

Podoconiosis is one of the few diseases that could potentially be eliminated within one generation. Nonetheless, the global distribution of the disease remains largely unknown. The global atlas of pod...

Integrated morbidity mapping of lymphatic filariasis and podoconiosis cases in 20 co-endemic districts of Ethiopia.

Lymphatic filariasis (LF) and podoconiosis are neglected tropical diseases (NTDs) that pose a significant physical, social and economic burden to endemic communities. Patients affected by the clinical...

Medical and Biotech [MESH] Definitions

None available.

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