NCT01160523

Promoting Consistent Shoe Use Among Children At High Risk for Podoconiosis

Completed Last updated 17 December 2019

What this trial tests

trial in Podoconiosis in 2,106 participants. Completed in 14 April 2016.

Timeline

14 June 2010

14 April 2016

Quick facts

Lead sponsor	National Human Genome Research Institute (NHGRI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,106
Start date	14 June 2010
Estimated completion	14 April 2016
Sites	1 location across Ethiopia

Conditions studied

• Podoconiosis — all drugs for Podoconiosis →
• Non-Filarial Elephantiasis — all drugs for Non-Filarial Elephantiasis →

Sponsor

National Human Genome Research Institute (NHGRI)

Who can join

Adults 9 to 15, any sex, with Podoconiosis or Non-Filarial Elephantiasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

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Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Mesoporous silica nanoparticles in glioblastoma: smart nano-platforms for targeted therapy and precision diagnosis.
   Hiremath P, Naik GARR, Roy AA, Kudarha R, et al · · 2026 · cited 1× · PMID 41574218 · DOI 10.1007/s13205-025-04639-1