Promoting Consistent Shoe Use Among Children At High Risk for Podoconiosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01160523
First received: July 9, 2010
Last updated: March 14, 2014
Last verified: January 2014
  Purpose

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.


Condition
Podoconiosis
Non-Filarial Elephantiasis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Promoting Consistent Shoe Use Among Children At High Risk for Podoconiosis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 2200
Study Start Date: June 2010
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.

  Eligibility

Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Children 9-15 years of age who have been identified to participate in the MFTPA shoe distribution.

EXCLUSION CRITERIA:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160523

Contacts
Contact: Colleen McBride, Ph.D. (301) 594-6788 cmcbride@nhgri.nih.gov

Locations
United States, Maryland
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Colleen McBride, Ph.D.    301-594-6788    cmcbride@nhgri.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Colleen McBride, Ph.D. National Human Genome Research Institute (NHGRI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01160523     History of Changes
Other Study ID Numbers: 999910142, 10-HG-N142
Study First Received: July 9, 2010
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Podoconiosis
Genetic Education
Primary Prevention
Ethiopa
Youth

Additional relevant MeSH terms:
Elephantiasis
Filariasis
Helminthiasis
Lymphatic Diseases
Lymphedema
Nematode Infections
Parasitic Diseases
Secernentea Infections
Spirurida Infections

ClinicalTrials.gov processed this record on October 20, 2014