Community-based Intergenerational Oral Health Study (Baby Smiles)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

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 (Outcomes Assessor) Primary Purpose: Health Services Research
Official Title:	Community-based Intergenerational Oral Health Promotion In Rural America

Resource links provided by NLM:

MedlinePlus related topics: Dental Health Postpartum Care

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) ]


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)
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:

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):

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.

Weinstein 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.

Milgrom 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.


Responsible Party:	Christine Riedy and Philip Weinstein, University of Washington
ClinicalTrials.gov Identifier:	NCT01120041 History of Changes
Other Study ID Numbers:	37124-C 5U54DE019346 ( U.S. NIH Grant/Contract ) 09-016E
Study First Received:	May 6, 2010
Last Updated:	January 10, 2011

ClinicalTrials.gov processed this record on September 21, 2017

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