Birth to Three - Cavity Free
BTCF
2 other identifiers
interventional
634
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
December 3, 2025
November 1, 2025
4.1 years
November 8, 2022
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Caries Status
The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions.
Visits 2 when children are 12 months of age
Caries Status
The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions.
Visits 3 when children are 24 months of age
Caries Status
The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions.
Visits 4 when children are 36 months of age
Secondary Outcomes (4)
Maternal knowledge questionnaire
Visit 1-4, including activities at 1- and 9-month between site visits
Children's oral health behavior questionnaire
Visit 1-4, including activities at 1- and 9-month between site visits
Levels of dental plaque
Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
Levels of mutans streptococci (MS)
Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
Study Arms (2)
SDT
EXPERIMENTALPregnant mothers will be randomly assigned to either an experimental group (Group 1) where mothers will receive autonomy-supportive messages informed by the SDT or a control group (Group 2) where mothers will receive the same oral health care messages delivered using a neutral style. All mothers will be exposed to oral health messages - one during pregnancy, one later when their child is 12 months of age, and one when their child is 24 months of age. Three months after receiving the oral health messages at each time point, mothers will be sent a follow-up booster message.
Control
OTHERPregnant mothers will be randomly assigned to either an experimental group (Group 1) where mothers will receive autonomy-supportive messages informed by the SDT or a control group (Group 2) where mothers will receive the same oral health care messages delivered using a neutral style. All mothers will be exposed to oral health messages - one during pregnancy, one later when their child is 12 months of age, and one when their child is 24 months of age. Three months after receiving the oral health messages at each time point, mothers will be sent a follow-up booster message.
Interventions
SDT is relatively unique among theories of motivation due to its focus on the quality, rather than the quantity, of motivation. Central to SDT is the distinction between selfdetermined or autonomous and non-self-determined or controlled forms of motivation. These types of motivation differ from one another based on the degree to which actions are (or are not) fully self-endorsed by the individual. Autonomous motivation reflects freely chosen and fully or whole-heartedly self-endorsed reasons for engaging in a behavior, such as "because it is important" and "because it is enjoyable". In contrast, controlled motivation reflects reasons for acting that are not self-endorsed because one is pressured into doing them because of internal pressure, such as "this is something I should do, even though I don't really want to", or because of environmental contingencies "because I have to; it is required that I do this".
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- Mothers who deliver their child prior to their first study intervention visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Anamosa WIC Clinic
Anamosa, Iowa, 52205, United States
Belle Plaine WIC Clinic
Belle Plaine, Iowa, 52208, United States
LCPH WIC Clinic
Cedar Rapids, Iowa, 52401, United States
Urban WIC Clinic
Cedar Rapids, Iowa, 52403, United States
Clinton WIC Clinic
Clinton, Iowa, 52732, United States
Columbus Junction WIC Clinic
Columbus Junction, Iowa, 52738, United States
Davenport WIC Clinic
Davenport, Iowa, 52801, United States
CHC Edgerton Clinic
Davenport, Iowa, 52803, United States
Dewitt WIC Clinic
De Witt, Iowa, 52742, United States
Johnson County WIC
Iowa City, Iowa, 52246, United States
Maquoketa WIC Clinic
Maquoketa, Iowa, 52060, United States
Marion WIC Clinic
Marion, Iowa, 52302, United States
Monticello WIC Clinic
Monticello, Iowa, 52310, United States
Muscatine WIC Clinic
Muscatine, Iowa, 52761, United States
Tipton WIC Clinic
Tipton, Iowa, 52772, United States
Vinton WIC Clinic
Vinton, Iowa, 52349, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karin Weber-Gasparoni, PhD
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- Principal investigator and clinical examiner will be blinded to group allocation
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Chair Pediatric Dentistry
Study Record Dates
First Submitted
November 8, 2022
First Posted
March 6, 2023
Study Start
March 1, 2023
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
December 3, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
The study will comply with NIH Public Access Policy, which ensures that the public has access to the published results of NIH-funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central within 12 months upon publication. The research team will be responsible for developing publication procedures and resolving authorship issues. Manuscripts will be reviewed by all the co-authors before submission. Data will be shared no later than the acceptance for publication of the main findings from the final data set.