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Clinical Trials/NCT01120041
NCT01120041UnknownPhase 3

Community-based Intergenerational Oral Health Promotion In Rural America

University of Washington8 sites in 1 country400 target enrollmentStarted: May 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Enrollment
400
Locations
8
Primary Endpoint
Visiting the dentist during pregnancy and up to two months postpartum for the mother and visiting the dentist before 18 months for the child.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

  • Not provided

Arms & Interventions

Prenatal Health Ed - Postpartum MI

Experimental

Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase

Intervention: motivational interviewing counseling (Behavioral)

Prenatal MI - Postpartum MI

Experimental

Motivational interviewing counseling given during the prenatal and postpartum phases

Intervention: motivational interviewing counseling (Behavioral)

Prenatal MI - Postpartum Health Ed

Experimental

Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase

Intervention: motivational interviewing counseling (Behavioral)

Prenatal Health Ed/Postpartum Health Ed

Placebo Comparator

Traditional health education given during the prenatal phase and the postpartum phase

Intervention: health education (Behavioral)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (8)

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