Birth to Three - Cavity Free
Public ClinicalTrials.gov record NCT05756413. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Birth to Three - Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Early childhood caries (ECC) is a potentially painful and debilitating disease, which represents a significant public health problem among young children. There are profound disparities in ECC experiences such that children from minority and low-income families suffer a disproportionate share of the disease burden. The likelihood of parents of high-ECC risk young children seeking prevention in dental facilities is low; therefore, there is a need to increase preventive dental opportunities where these children already seek health care services. In particular, there is an urgent need to develop and evaluate ECC behavioral interventions for use in public health settings attended by high-risk children. Many authors recommend early implementation of oral health education as one means of preventing ECC. However, major issues discussed in the oral health promotion literature involve a lack of effectiveness among programs based on education alone, as well as a lack of high quality preventive interventions using evidence-based psychological and behavioral strategies. Our research team has been the first to introduce to the ECC prevention arena the self-determination theory (SDT) of motivation, internalization, and healthy functioning, proven effective in promoting positive behavioral changes in several other fields, including oral health care. The investigators have demonstrated that SDT has great promise as a motivational approach by providing evidence, based on results from our R21 (R21-DE016483) study, of the effectiveness of SDT in changing several desirable oral health behaviors for ECC prevention. Building upon the rigor of our previous experience and formative research work in the past several years, the investigators propose a Stage II NIH Model research project that will compare the efficacy of autonomy-supportive videotaped oral health messages framed by SDT to more traditional neutral videotaped messages. The investigators intend to recruit 634 pregnant mothers enrolled in Iowa Women, Infants and Children (WIC) Supplemental Nutrition Programs and follow them until their future child is 36 months old. The primary outcome of interest will be children's caries status. Secondary outcomes will be changes in children's oral health behaviors conducive to better oral hygiene and dietary habits, as well as lower levels of dental plaque and mutans streptococci.
Study identification
- NCT ID
- NCT05756413
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,268 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2023
- Primary completion
- Mar 30, 2027
- Completion
- Mar 30, 2027
- Last update posted
- Jul 20, 2026
2023 – 2027
United States locations
- U.S. sites
- 16
- U.S. states
- 1
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Anamosa WIC Clinic | Anamosa | Iowa | 52205 | — |
| Belle Plaine WIC Clinic | Belle Plaine | Iowa | 52208 | — |
| LCPH WIC Clinic | Cedar Rapids | Iowa | 52401 | — |
| Urban WIC Clinic | Cedar Rapids | Iowa | 52403 | — |
| Clinton WIC Clinic | Clinton | Iowa | 52732 | — |
| Columbus Junction WIC Clinic | Columbus Junction | Iowa | 52738 | — |
| Davenport WIC Clinic | Davenport | Iowa | 52801 | — |
| CHC Edgerton Clinic | Davenport | Iowa | 52803 | — |
| Dewitt WIC Clinic | De Witt | Iowa | 52742 | — |
| Johnson County WIC | Iowa City | Iowa | 52246 | — |
| Maquoketa WIC Clinic | Maquoketa | Iowa | 52060 | — |
| Marion WIC Clinic | Marion | Iowa | 52302 | — |
| Monticello WIC Clinic | Monticello | Iowa | 52310 | — |
| Muscatine WIC Clinic | Muscatine | Iowa | 52761 | — |
| Tipton WIC Clinic | Tipton | Iowa | 52772 | — |
| Vinton WIC Clinic | Vinton | Iowa | 52349 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05756413, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 20, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05756413 live on ClinicalTrials.gov.