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
Recruitment status was Recruiting
Sponsor:
University of Washington
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01120041
First received: May 6, 2010
Last updated: January 10, 2011
Last verified: January 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 |
| 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
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
Investigators
| Principal Investigator: | Christine A Riedy, PhD, MPH | University of Washington | |
| Principal Investigator: | Philip Weinstein, PhD | University of Washington |
More Information
No publications provided by University of Washington
Additional 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 March 01, 2015