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Community-based Intergenerational Oral Health Study (Baby Smiles)

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ClinicalTrials.gov Identifier: NCT01120041
Recruitment Status : Unknown
Verified January 2011 by University of Washington.
Recruitment status was:  Recruiting
First Posted : May 10, 2010
Last Update Posted : January 12, 2011
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
University of Washington

Brief Summary:
The purpose of this study is to determine whether giving brief motivational interviewing counseling during the prenatal and/or postnatal period(s) will increase utilization of preventive dental care and improve the oral health of rural, low-income pregnant and postpartum women and their children, and to increase the number of home oral health practices taken by these women to prevent caries in their young children.

Condition or disease Intervention/treatment Phase
Preventive Health Services Behavioral: motivational interviewing counseling Behavioral: health education Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Community-based Intergenerational Oral Health Promotion In Rural America
Study Start Date : May 2010
Estimated Primary Completion Date : May 2013
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prenatal MI - Postpartum MI
Motivational interviewing counseling given during the prenatal and postpartum phases
Behavioral: motivational interviewing counseling
Motivational interviewing counseling given during the prenatal and postpartum phases
Experimental: Prenatal MI - Postpartum Health Ed
Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
Behavioral: motivational interviewing counseling
Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
Experimental: Prenatal Health Ed - Postpartum MI
Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
Behavioral: motivational interviewing counseling
Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
Placebo Comparator: Prenatal Health Ed/Postpartum Health Ed
Traditional health education given during the prenatal phase and the postpartum phase
Behavioral: health education
Traditional health education given during the prenatal phase and the postpartum phase



Primary Outcome Measures :
  1. Visiting the dentist during pregnancy and up to two months postpartum for the mother and visiting the dentist before 18 months for the child. [ Time Frame: During pregnancy and up to two months post partum (mother); up to 18 months (child) ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant (week 26 or earlier)
  • At least 15 years of age
  • Medicaid eligible
  • Speaks English
  • Willing and able to comply with study instructions
  • Mother AND child available for length of the study (~ 24 months)

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120041


Contacts
Contact: Christine A Riedy, PhD, MPH 206-616-1619 cariedy@u.washington.edu

Locations
United States, Oregon
Josephine County Public Health Department Recruiting
Grants Pass, Oregon, United States, 97526
Jefferson County Public Health Department Recruiting
Madras, Oregon, United States, 97741
Lincoln County Human Services Department Recruiting
Newport, Oregon, United States, 97365
Douglas County Health & Social Services Recruiting
Roseburg, Oregon, United States, 97470-3093
Sponsors and Collaborators
University of Washington
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Christine A Riedy, PhD, MPH University of Washington
Principal Investigator: Philip Weinstein, PhD University of Washington