Community-based Intergenerational Oral Health Study
Baby Smiles
3 other identifiers
interventional
400
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2010
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 6, 2010
CompletedFirst Posted
Study publicly available on registry
May 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedJanuary 12, 2011
January 1, 2011
3 years
May 6, 2010
January 10, 2011
Conditions
Outcome Measures
Primary Outcomes (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.
During pregnancy and up to two months post partum (mother); up to 18 months (child)
Study Arms (4)
Prenatal MI - Postpartum MI
EXPERIMENTALMotivational interviewing counseling given during the prenatal and postpartum phases
Prenatal MI - Postpartum Health Ed
EXPERIMENTALMotivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
Prenatal Health Ed - Postpartum MI
EXPERIMENTALTraditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
Prenatal Health Ed/Postpartum Health Ed
PLACEBO COMPARATORTraditional health education given during the prenatal phase and the postpartum phase
Interventions
Motivational interviewing counseling given during the prenatal and postpartum phases
Traditional health education given during the prenatal phase and the postpartum phase
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Josephine County Public Health Department
Grants Pass, Oregon, 97526, United States
Jefferson County Public Health Department
Madras, Oregon, 97741, United States
Lincoln County Human Services Department
Newport, Oregon, 97365, United States
Douglas County Health & Social Services
Roseburg, Oregon, 97470-3093, United States
Related Publications (3)
Riedy CA, Weinstein P, Mancl L, Garson G, Huebner CE, Milgrom P, Grembowski D, Shepherd-Banigan M, Smolen D, Sutherland M. Dental attendance among low-income women and their children following a brief motivational counseling intervention: A community randomized trial. Soc Sci Med. 2015 Nov;144:9-18. doi: 10.1016/j.socscimed.2015.09.005. Epub 2015 Sep 8.
PMID: 26372934DERIVEDWeinstein P, Milgrom P, Riedy CA, Mancl LA, Garson G, Huebner CE, Smolen D, Sutherland M, Nykamp A. Treatment fidelity of brief motivational interviewing and health education in a randomized clinical trial to promote dental attendance of low-income mothers and children: Community-Based Intergenerational Oral Health Study "Baby Smiles". BMC Oral Health. 2014 Feb 24;14:15. doi: 10.1186/1472-6831-14-15.
PMID: 24559035DERIVEDMilgrom P, Riedy CA, Weinstein P, Mancl LA, Garson G, Huebner CE, Smolen D, Sutherland M. Design of a community-based intergenerational oral health study: "Baby Smiles". BMC Oral Health. 2013 Aug 6;13:38. doi: 10.1186/1472-6831-13-38.
PMID: 23914908DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Christine A Riedy, PhD, MPH
University of Washington
- PRINCIPAL INVESTIGATOR
Philip Weinstein, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 6, 2010
First Posted
May 10, 2010
Study Start
May 1, 2010
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
January 12, 2011
Record last verified: 2011-01