Preventing early childhood cavities in high-risk families

Birth to Three - Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention

This study is testing a new way to help pregnant women in WIC programs improve their children's dental health to prevent cavities in young kids from high-risk families.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 634 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: University of Iowa (other)
• Locations: 16 sites (Anamosa, Iowa and 15 other locations)
• Trial ID: NCT05756413 on ClinicalTrials.gov

What this trial studies

This study aims to address early childhood caries (ECC) by implementing a behavioral intervention based on self-determination theory among pregnant women enrolled in WIC programs. The intervention includes an autonomy-supportive videotaped oral health message designed to improve oral health behaviors in mothers and their children. Participants will be recruited from various WIC clinics in Iowa, and the effectiveness of this intervention will be compared to standard dental educational brochures. The study seeks to enhance preventive dental care access for children at high risk for ECC, particularly those from minority and low-income families.

Who should consider this trial

Good fit: Ideal candidates for this study are WIC-participating pregnant women aged 18 to 45 who are between 12 and 36 weeks of gestation.

Not a fit: Patients who deliver their child before the first study intervention visit will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the incidence of early childhood caries in high-risk populations.

How similar studies have performed: Previous studies have shown promising results with similar behavioral interventions aimed at improving oral health behaviors among high-risk populations.

Eligibility criteria

Inclusion Criteria:

* WIC-participating pregnant women who are 18 to 45 years old
* Between 12 and 36 weeks of the gestational period
* Able to speak, understand and read English or Spanish
* No intention to move away in the next 4 years

Exclusion Criteria:

- Mothers who deliver their child prior to their first study intervention visit

Where this trial is running

Anamosa, Iowa and 15 other locations

• Anamosa WIC Clinic — Anamosa, Iowa, United States (RECRUITING)
• Belle Plaine WIC Clinic — Belle Plaine, Iowa, United States (RECRUITING)
• LCPH WIC Clinic — Cedar Rapids, Iowa, United States (RECRUITING)
• Urban WIC Clinic — Cedar Rapids, Iowa, United States (RECRUITING)
• Clinton WIC Clinic — Clinton, Iowa, United States (RECRUITING)
• Columbus Junction WIC Clinic — Columbus Junction, Iowa, United States (RECRUITING)
• Davenport WIC Clinic — Davenport, Iowa, United States (RECRUITING)
• CHC Edgerton Clinic — Davenport, Iowa, United States (RECRUITING)
• Dewitt WIC Clinic — De Witt, Iowa, United States (RECRUITING)
• Johnson County WIC — Iowa City, Iowa, United States (RECRUITING)
• Maquoketa WIC Clinic — Maquoketa, Iowa, United States (RECRUITING)
• Marion WIC Clinic — Marion, Iowa, United States (RECRUITING)
• Monticello WIC Clinic — Monticello, Iowa, United States (RECRUITING)
• Muscatine WIC Clinic — Muscatine, Iowa, United States (RECRUITING)
• Tipton WIC Clinic — Tipton, Iowa, United States (RECRUITING)
• Vinton WIC Clinic — Vinton, Iowa, United States (RECRUITING)

Study contacts

• Principal investigator: Karin Weber-Gasparoni, PhD — University of Iowa
• Study coordinator: Karin Weber-Gasparoni, PhD

Conditions: Caries,Dental