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Sponsors and Collaborators: |
National Institute of Dental and Craniofacial Research (NIDCR) University of Michigan Delta Dental Fund of Michigan |
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Information provided by: | National Institute of Dental and Craniofacial Research (NIDCR) |
ClinicalTrials.gov Identifier: | NCT00103493 |
The purpose of this study is to evaluate whether an oral health education program that is tailored to caregivers' understanding and acceptance of information on how to prevent tooth decay will lead to improvement in behaviors conducive to good oral health and reduction in tooth decay in his or her children.
Condition | Intervention | Phase |
---|---|---|
Dental Caries Oral Hygiene Oral Health Dental Health |
Behavioral: Motivational interviewing Behavioral: Targeted DVD-based educational program |
Phase III |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Efficacy of a Tailored Oral Health Education Program |
Estimated Enrollment: | 1021 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | August 2005 |
The Detroit Dental Health Project (DDHP) is a seven-year research study designed to identify the determinants of variation in prevalence and incidence of dental caries among low-income African-American children in Detroit. The children were randomly selected from housing units located in the lowest income areas (less than 250% of the poverty line). After over a year of preparation and testing, the DDHP listed over 18,000 housing and non-housing units in 118 randomly selected low-income neighborhoods in Detroit. A total of 12,000 housing units were randomly sampled and contacted over a period of one year (September 2001 – August 2002) in order to recruit a representative sample of African American children. Field interviewers contacted the selected housing units. The recruitment process located and scheduled around 1,400 families to visit the Dental Assessment Center (DAC). Of those, 1,021 visited the DAC and completed examinations and interviews (Phase I).
The long-term objective of this project is to develop an effective multi-component tailored/targeted behavioral intervention to promote and maintain good oral health and prevent oral diseases among low-income children. To achieve this, a multimedia-based multi-level intervention has been designed to be easy to use and easy to disseminate for large-scale use.
The efficacy of the Multi-Component Tailored/Targeted Intervention that will be delivered using motivational interviewing and a targeted educational video designed and produced for the specific population in comparison with the non-tailored health education (targeted educational video only – control group) will be tested in a randomized controlled trial. In Phase II of the Detroit Dental Health Project, the 1,021 low-income African Americans recruited will be randomly assigned to one of the two intervention groups. A dental examination will provide the baseline measurement and changes in the outcomes will be assessed in the follow-up examination after two years. Participants in the control and intervention groups will complete a questionnaire about their oral health and related behaviors. Participants in the control group will receive standard oral hygiene and caries risk counseling using only the educational video without any motivational interviewing (equivalent to a counseling session conducted by a dentist).
The 1,021 families have been randomized using a list of randomly generated numbers. The allocation of the assignment is being concealed from the analysis team and the examining dentist. After each session, the participants receive a “recipe” for oral health with a picture of their child. The control group participants receive a standard plan; whereas the caregivers in the intervention group receive the specific plan they have developed with the motivational interviewer.
After the intervention/control session, the participants are being followed by telephone contact to review the progress in oral health behaviors and answer questions. Follow-up questionnaires will be administered after 2-4 weeks, at 6 months, and 2 years after the intervention/control session.
Ages Eligible for Study: | 15 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Dental Assessment Center | |
Detroit,, Michigan, United States, 48215 |
Principal Investigator: | Amid Ismail | University of Michigan |
Study ID Numbers: | NIDCR-14261 |
Study First Received: | February 9, 2005 |
Last Updated: | October 25, 2006 |
ClinicalTrials.gov Identifier: | NCT00103493 History of Changes |
Health Authority: | United States: Federal Government |
Tooth Diseases Stomatognathic Diseases Dental Caries |
Tooth Diseases Stomatognathic Diseases Tooth Demineralization Dental Caries |