Caries,DentalBTCFNCT05756413
Birth to Three - Cavity Free
A study testing Self-determination theory in people with Caries,Dental, run by University of Iowa at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Self-determination theory
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,268 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Mar 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Mothers who deliver their child prior to their first study intervention visit
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
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
About this study
Official title: Birth to Three - Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention
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.
Read the detailed description
The UH3 study is considered a Stage II research according to the NIH Stage Model and builds directly upon the rigor of our previous formative research work, including a study supported by R21 DE016483-02. The R21 study tested the effectiveness of an autonomy-supportive videotaped oral health message informed by the self-determination theory (SDT) as a preventive behavioral approach for ECC among WIC-enrolled 12- to 49-month old children and their mothers. This grant was exploratory in nature and did not allow our research team to have a control group. In order to test the study intervention against the standard dental educational brochures, funding was obtained through the University of Iowa (UI) College of Dentistry to recruit participants to a control group. This concurrent control group was recruited to facilitate future study planning, including estimation of effect sizes. Results from the R21 study provided evidence of the effectiveness of the SDT-framed autonomy-supportive videotaped intervention in changing several oral health behaviors for ECC prevention: increased children's daily brushing habits, use of fluoridated toothpaste, mother's lifting their children's lip to look for early signs of ECC, and compliance with the consumption of no more than 4 ounces of 100% juice daily. Additional behavioral changes included decreased nighttime feeding other than water, and reduced number of daily cariogenic snacks consumed. The future proposed UH3 study will improve upon our previous investigations in two ways. First, the investigators will enhance the expected effectiveness of our experimental manipulation by creating and implementing a more research-informed age targeted oral health message. Second, the UH3 mechanism will allow us to enhance our capacity to assess the effectiveness of the SDT-derived videotaped oral health message compared to a control group with an optimal, sufficiently powered sample size. The investigators believe they have a strong scientific foundation for this project based on the rigor of our prior research efforts. Our approach will have a broader impact in that it tests a low-cost behavioral intervention that can be used in WIC clinics and other public health settings across the nation. As such, the use of evidence-based autonomy-supportive messages could efficiently disseminate an important and effective health promotion message that has great generalizability and the potential to greatly reduce the burden of ECC among some of the most vulnerable populations.
- Conditions
- Caries,Dental
- Being tested
- Self-determination theory
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-determination theoryBehavioural
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".
| Study group | Role | What they receive |
|---|---|---|
| SDT | Experimental | Pregnant 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. Receives: Behavioral: Self-determination theory |
| Control | Other | Pregnant 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. Receives: Behavioral: Self-determination theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Visits 4 when children are 36 months of age
Secondary outcomes (4)
Maternal knowledge questionnaire
Secondary outcomes will be changes in maternal knowledge on oral health care
Measured: Visit 1-4, including activities at 1- and 9-month between site visits
Children's oral health behavior questionnaire
Secondary outcomes will be changes in maternal oral health behaviors towards their children
Measured: Visit 1-4, including activities at 1- and 9-month between site visits
Levels of dental plaque
Secondary outcomes will be changes in levels of children's dental plaque. Visible plaque will be assessed first and recorded as present or absent for the maxillary and mandibular incisors and molars. The number of maxillary and mandibular incisors and molars with plaque will also be recorded.
Measured: Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
Levels of mutans streptococci (MS)
Secondary outcomes will be changes in levels of children's mutans streptococci (MS)
Measured: Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Mar 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,268 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Weber-Gasparoni, University of Iowa
- Investigators
- Karin Weber-Gasparoni, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756413
- Sponsor's protocol ID
- 202002391
- Other IDs
- 1UG3DE029443-01
- Acronym
- BTCF
- Status last verified
- Jul 2026
- First submitted
- 8 Nov 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Birth to Three - Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention
- ClinicalTrials.gov ID
- NCT05756413
- Acronym / sponsor ID
- BTCF / 202002391
- Conditions
- Caries,Dental
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,268 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Mar 2023 (actual)
- 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.
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.
Detailed description
The UH3 study is considered a Stage II research according to the NIH Stage Model and builds directly upon the rigor of our previous formative research work, including a study supported by R21 DE016483-02. The R21 study tested the effectiveness of an autonomy-supportive videotaped oral health message informed by the self-determination theory (SDT) as a preventive behavioral approach for ECC among WIC-enrolled 12- to 49-month old children and their mothers. This grant was exploratory in nature and did not allow our research team to have a control group. In order to test the study intervention against the standard dental educational brochures, funding was obtained through the University of Iowa (UI) College of Dentistry to recruit participants to a control group. This concurrent control group was recruited to facilitate future study planning, including estimation of effect sizes. Results from the R21 study provided evidence of the effectiveness of the SDT-framed autonomy-supportive videotaped intervention in changing several oral health behaviors for ECC prevention: increased children's daily brushing habits, use of fluoridated toothpaste, mother's lifting their children's lip to look for early signs of ECC, and compliance with the consumption of no more than 4 ounces of 100% juice daily. Additional behavioral changes included decreased nighttime feeding other than water, and reduced number of daily cariogenic snacks consumed. The future proposed UH3 study will improve upon our previous investigations in two ways. First, the investigators will enhance the expected effectiveness of our experimental manipulation by creating and implementing a more research-informed age targeted oral health message. Second, the UH3 mechanism will allow us to enhance our capacity to assess the effectiveness of the SDT-derived videotaped oral health message compared to a control group with an optimal, sufficiently powered sample size. The investigators believe they have a strong scientific foundation for this project based on the rigor of our prior research efforts. Our approach will have a broader impact in that it tests a low-cost behavioral intervention that can be used in WIC clinics and other public health settings across the nation. As such, the use of evidence-based autonomy-supportive messages could efficiently disseminate an important and effective health promotion message that has great generalizability and the potential to greatly reduce the burden of ECC among some of the most vulnerable populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SDT | Experimental | Behavioral: Self-determination theoryPregnant 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 | Other | Behavioral: Self-determination theoryPregnant 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Mothers who deliver their child prior to their first study intervention visit
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 |
|---|---|---|
| Self-determination theorySDT 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". | Behavioural | Control, SDT |
Primary outcome
Caries Status
Time frame: Visits 2 when children are 12 months of age
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.
Caries Status
Time frame: Visits 3 when children are 24 months of age
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.
Caries Status
Time frame: Visits 4 when children are 36 months of age
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.
4 secondary outcomes
Maternal knowledge questionnaire
Time frame: Visit 1-4, including activities at 1- and 9-month between site visits
Children's oral health behavior questionnaire
Time frame: Visit 1-4, including activities at 1- and 9-month between site visits
Levels of dental plaque
Time frame: Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
Levels of mutans streptococci (MS)
Time frame: Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Karin Weber-Gasparoni, PhD principal investigator
University of Iowa
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-determination theory in people with Caries,Dental, run by University of Iowa at 16 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 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries Status (time frame: Visits 2 when children are 12 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2026.