Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Community-based Intergenerational Oral Health Study (Baby Smiles)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01120041
First received: May 6, 2010
Last updated: January 10, 2011
Last verified: January 2011
History of Changes
  Purpose
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 Intervention Phase
Preventive Health Services
 Behavioral: motivational interviewing counseling
Behavioral: health education
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Community-based Intergenerational Oral Health Promotion In Rural America

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
Estimated Enrollment: 400
Study Start Date: May 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility
Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Genders 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:

  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: 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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Christine Riedy and Philip Weinstein, University of Washington
ClinicalTrials.gov Identifier: NCT01120041     History of Changes
Other Study ID Numbers: 37124-C  5U54DE019346  09-016E 
Study First Received: May 6, 2010
Last Updated: January 10, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 27, 2016