PodoconiosisNCT01160523
Promoting Consistent Shoe Use Among Children At High Risk for Podoconiosis
An observational study of Podoconiosis and Non-Filarial Elephantiasis, run by National Human Genome Research Institute (NHGRI) at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Podoconiosis, Non-Filarial Elephantiasis
- How many people
- 2,106 participants
- Where
- 1 siteEthiopia
- Study dates
- 14 Jun 2010to 14 Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 9-15 years of age who have been identified to participate in the MFTPA shoe distribution.
Who cannot join
- Children younger than 9 or older than 15
- Children who show clinical evidence of podoconiosis or have confirmed diagnosis of another pathology that might affect participation in study activities (for example tuberculosis)
- Children for whom we are unable to gain parental permission.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
...
Read the 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.
- Conditions
- Podoconiosis, Non-Filarial Elephantiasis
- Keywords
- Podoconiosis, Genetic Education, Primary Prevention, Ethiopa, Youth
- Medical subject headings
- Elephantiasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study start14 Jun 2010
- Study completion14 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PodoconiosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,106 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Vence L Bonham, J.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160523
- Sponsor's protocol ID
- 999910142
- Other IDs
- 10-HG-N142
- Status last verified
- 14 Apr 2016
- First submitted
- 9 Jul 2010
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Abebe T, Aase A. Children, AIDS and the politics of orphan care in Ethiopia: the extended family revisited. Soc Sci Med. 2007 May;64(10):2058-69. doi: 10.1016/j.socscimed.2007.02.004. Epub 2007 Mar 26.
PubMed 17379371Ayaya SO, Esamai FO. Health problems of street children in Eldoret, Kenya. East Afr Med J. 2001 Dec;78(12):624-9. doi: 10.4314/eamj.v78i12.8930.
PubMed 12199442Davey G, Tekola F, Newport MJ. Podoconiosis: non-infectious geochemical elephantiasis. Trans R Soc Trop Med Hyg. 2007 Dec;101(12):1175-80. doi: 10.1016/j.trstmh.2007.08.013. Epub 2007 Oct 31.
PubMed 17976670
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Consistent Shoe Use Among Children At High Risk for Podoconiosis
- ClinicalTrials.gov ID
- NCT01160523
- Acronym / sponsor ID
- 999910142
- Conditions
- Podoconiosis, Non-Filarial Elephantiasis
- Keywords
- Podoconiosis, Genetic Education, Primary Prevention, Ethiopa, Youth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,106 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 14 Jun 2010
- Study completion
- 14 Apr 2016
- First posted
- 12 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 9-15 years of age who have been identified to participate in the MFTPA shoe distribution.
Key exclusion criteria (3 listed)
- Children younger than 9 or older than 15
- Children who show clinical evidence of podoconiosis or have confirmed diagnosis of another pathology that might affect participation in study activities (for example tuberculosis)
- Children for whom we are unable to gain parental permission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Background: PubMed 17379371Abebe T, Aase A. Children, AIDS and the politics of orphan care in Ethiopia: the extended family revisited. Soc Sci Med. 2007 May;64(10):2058-69. doi: 10.1016/j.socscimed.2007.02.004. Epub 2007 Mar 26.
- Background: PubMed 12199442Ayaya SO, Esamai FO. Health problems of street children in Eldoret, Kenya. East Afr Med J. 2001 Dec;78(12):624-9. doi: 10.4314/eamj.v78i12.8930.
- Background: PubMed 17976670Davey G, Tekola F, Newport MJ. Podoconiosis: non-infectious geochemical elephantiasis. Trans R Soc Trop Med Hyg. 2007 Dec;101(12):1175-80. doi: 10.1016/j.trstmh.2007.08.013. Epub 2007 Oct 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vence L Bonham, J.D. principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Podoconiosis and Non-Filarial Elephantiasis, run by National Human Genome Research Institute (NHGRI) at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01160523, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.