Community-based Intergenerational Oral Health Study

Preventive Health Services Clinical Trial

— Baby Smiles  

Official title:

Community-based Intergenerational Oral Health Promotion In Rural America

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01120041
• Other study ID #: 37124-C
• Secondary ID: 5U54DE01934609-0
• Status: Recruiting
• Phase: Phase 3
• First received: May 6, 2010
• Last updated: January 10, 2011
• Start date: May 2010
• Est. completion date: May 2013

Study information

• Verified date: January 2011
• Source: University of Washington
• Contact: Christine A Riedy, PhD, MPH
• Phone: 206-616-1619
• Email: cariedy[@]u.washington.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Preventive Health Services

Intervention

Behavioral:
• motivational interviewing counseling
Motivational interviewing counseling given during the prenatal and postpartum phases
• motivational interviewing counseling
Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
• motivational interviewing counseling
Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
• health education
Traditional health education given during the prenatal phase and the postpartum phase

Locations

Country	Name	City	State
United States	Josephine County Public Health Department	Grants Pass	Oregon
United States	Jefferson County Public Health Department	Madras	Oregon
United States	Lincoln County Human Services Department	Newport	Oregon
United States	Douglas County Health & Social Services	Roseburg	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visiting the dentist during pregnancy and up to two months postpartum for the mother and visiting the dentist before 18 months for the child.		During pregnancy and up to two months post partum (mother); up to 18 months (child)	No