title: Design and implementation of a dental caries prevention trial in remote Canadian Aboriginal communities.
abstract: BACKGROUND
  The goal of this cluster randomized trial is to test the effectiveness of a counseling approach, Motivational Interviewing, to control dental caries in young Aboriginal children. Motivational Interviewing, a client-centred, directive counseling style, has not yet been evaluated as an approach for promotion of behaviour change in indigenous communities in remote settings.
  
  
  METHODS
  Aboriginal women were hired from the 9 communities to recruit expectant and new mothers to the trial, administer questionnaires and deliver the counseling to mothers in the test communities. The goal is for mothers to receive the intervention during pregnancy and at their child's immunization visits. Data on children's dental health status and family dental health practices will be collected when children are 30-months of age. The communities were randomly allocated to test or control group by a random "draw" over community radio. Sample size and power were determined based on an anticipated 20% reduction in caries prevalence. Randomization checks were conducted between groups.
  
  
  CONCLUSIONS
  In the 5 test and 4 control communities, 272 of the original target sample size of 309 mothers have been recruited over a two-and-a-half year period. A power calculation using the actual attained sample size showed power to be 79% to detect a treatment effect. If an attrition fraction of 4% per year is maintained, power will remain at 80%. Power will still be > 90% to detect a 25% reduction in caries prevalence. The distribution of most baseline variables was similar for the two randomized groups of mothers. However, despite the random assignment of communities to treatment conditions, group differences exist for stage of pregnancy and prior tooth extractions in the family. Because of the group imbalances on certain variables, control of baseline variables will be done in the analyses of treatment effects. This paper explains the challenges of conducting randomized trials in remote settings, the importance of thorough community collaboration, and also illustrates the likelihood that some baseline variables that may be clinically important will be unevenly split in group-randomized trials when the number of groups is small.
  
  
  BACKGROUND
  This trial is registered as ISRCTN41467632.
authors.affiliation: Division of Pediatric Dentistry, Faculty of Dentistry, University of British Columbia, 2199 Wesbrook Mall, Vancouver, V6T 1Z3, Canada. rosha@interchange.ubc.ca
authors.forename: Rosamund
authors.initials: R
authors.lastname: Harrison
authors.forename: Jacques
authors.initials: J
authors.lastname: Veronneau
authors.forename: Brian
authors.initials: B
authors.lastname: Leroux
mesh_terms: D044467:American Indian or Alaska Native / Q000523:psychology; D002327:Cariostatic Agents / Q000627:therapeutic use; D002675:Child, Preschool; D016000:Cluster Analysis; D003731:Dental Caries / Q000208:ethnology / Q000517:prevention & control* / Q000523:psychology; D003752:Dental Health Services; D037001:Directive Counseling; D005260:Female; D005460:Fluorides, Topical / Q000627:therapeutic use; D015438:Health Behavior; D006267:Health Education, Dental; D007722:Health Knowledge, Attitudes, Practice; D006303:Health Services, Indigenous; D006801:Humans; D007223:Infant; D007406:Interview, Psychological; D008297:Male; D009042:Motivation; D010174:Pamphlets; D011247:Pregnancy; D015995:Prevalence; D011792:Quebec / Q000453:epidemiology; D018401:Sample Size; D016037:Single-Blind Method; D011795:Surveys and Questionnaires
chemical_list: D002327:Cariostatic Agents; D005460:Fluorides, Topical
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