Preventive Health ServicesPhase 3Baby SmilesNCT01120041
Community-based Intergenerational Oral Health Study
A Phase 3 study testing motivational interviewing counseling and health education in people with Preventive Health Services, run by University of Washington at 4 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preventive Health Services
- What is being tested?
- motivational interviewing counseling and health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2010to May 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Josephine County Public Health Department
Grants Pass, Oregon, 97526
- Recruiting
Jefferson County Public Health Department
Madras, Oregon, 97741
- Recruiting
Lincoln County Human Services Department
Newport, Oregon, 97365
- Recruiting
Douglas County Health & Social Services
Roseburg, Oregon, 97470-3093
About this study
Official title: Community-based Intergenerational Oral Health Promotion In Rural America
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.
- Conditions
- Preventive Health Services
- Being tested
- motivational interviewing counseling, health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational interviewing counselingBehavioural
Motivational interviewing counseling given during the prenatal and postpartum phases
motivational interviewing counselingBehavioural
Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
motivational interviewing counselingBehavioural
Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
health educationBehavioural
Traditional health education given during the prenatal phase and the postpartum phase
| Study group | Role | What they receive |
|---|---|---|
| Prenatal MI - Postpartum MI | Experimental | Motivational interviewing counseling given during the prenatal and postpartum phases Receives: Behavioral: motivational interviewing counseling |
| Prenatal MI - Postpartum Health Ed | Experimental | Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase Receives: Behavioral: motivational interviewing counseling |
| Prenatal Health Ed - Postpartum MI | Experimental | Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase Receives: Behavioral: motivational interviewing counseling |
| Prenatal Health Ed/Postpartum Health Ed | Placebo comparator | Traditional health education given during the prenatal phase and the postpartum phase Receives: Behavioral: health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visiting the dentist during pregnancy and up to two months postpartum for the mother and visiting the dentist before 18 months for the child.
Measured: During pregnancy and up to two months post partum (mother); up to 18 months (child)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Preventive Health ServicesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Investigators
- Christine A Riedy, PhD, MPH, Principal investigator, University of WashingtonPhilip Weinstein, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01120041
- Sponsor's protocol ID
- 37124-C
- Other IDs
- 5U54DE019346, 09-016E
- Acronym
- Baby Smiles
- Status last verified
- Jan 2011
- First submitted
- 6 May 2010
- Last updated
- 12 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26372934Weinstein 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.
PubMed 24559035Milgrom 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.
PubMed 23914908
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Intergenerational Oral Health Promotion In Rural America
- ClinicalTrials.gov ID
- NCT01120041
- Acronym / sponsor ID
- Baby Smiles / 37124-C
- Conditions
- Preventive Health Services
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- May 2010
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 10 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prenatal MI - Postpartum MI | Experimental | Behavioral: motivational interviewing counselingMotivational interviewing counseling given during the prenatal and postpartum phases |
| Prenatal MI - Postpartum Health Ed | Experimental | Behavioral: motivational interviewing counselingMotivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase |
| Prenatal Health Ed - Postpartum MI | Experimental | Behavioral: motivational interviewing counselingTraditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase |
| Prenatal Health Ed/Postpartum Health Ed | Placebo comparator | Behavioral: health educationTraditional health education given during the prenatal phase and the postpartum phase |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant (week 26 or earlier)
- At least 15 years of age
- Medicaid eligible
- Speaks English
- Willing and able to comply with study instructions
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motivational interviewing counselingMotivational interviewing counseling given during the prenatal and postpartum phases | Behavioural | Prenatal MI - Postpartum MI |
| motivational interviewing counselingMotivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase | Behavioural | Prenatal MI - Postpartum Health Ed |
| motivational interviewing counselingTraditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase | Behavioural | Prenatal Health Ed - Postpartum MI |
| health educationTraditional health education given during the prenatal phase and the postpartum phase | Behavioural | Prenatal Health Ed/Postpartum Health Ed |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2011.
- Derived from this study: PubMed 26372934Riedy 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.
- Derived from this study: PubMed 24559035Weinstein 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.
- Derived from this study: PubMed 23914908Milgrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine A Riedy, PhD, MPH principal investigator
University of Washington
Philip Weinstein, PhD principal investigator
University of Washington
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing motivational interviewing counseling and health education in people with Preventive Health Services, run by University of Washington at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine A Riedy, PhD, MPH (206-616-1619, cariedy@u.washington.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01120041, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2011.