Birth to Three - Cavity Free

Caries,Dental Clinical Trial

— BTCF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756413
• Other study ID #: 202002391
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: August 2023
• Source: University of Iowa
• Contact: Karin Weber-Gasparoni, PhD
• Phone: 3196215874
• Email: karin-weber[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 634
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

Behavioral:
• Self-determination theory
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".

Locations

Country	Name	City	State
United States	Anamosa WIC Clinic	Anamosa	Iowa
United States	Belle Plaine WIC Clinic	Belle Plaine	Iowa
United States	LCPH WIC Clinic	Cedar Rapids	Iowa
United States	Urban WIC Clinic	Cedar Rapids	Iowa
United States	Clinton WIC Clinic	Clinton	Iowa
United States	Columbus Junction WIC Clinic	Columbus Junction	Iowa
United States	CHC Edgerton Clinic	Davenport	Iowa
United States	Davenport WIC Clinic	Davenport	Iowa
United States	Dewitt WIC Clinic	De Witt	Iowa
United States	Johnson County WIC	Iowa City	Iowa
United States	Maquoketa WIC Clinic	Maquoketa	Iowa
United States	Marion WIC Clinic	Marion	Iowa
United States	Monticello WIC Clinic	Monticello	Iowa
United States	Muscatine WIC Clinic	Muscatine	Iowa
United States	Tipton WIC Clinic	Tipton	Iowa
United States	Vinton WIC Clinic	Vinton	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Maternal knowledge questionnaire	Secondary outcomes will be changes in maternal knowledge on oral health care	Visit 1-4, including activities at 1- and 9-month between site visits
Secondary	Children's oral health behavior questionnaire	Secondary outcomes will be changes in maternal oral health behaviors towards their children	Visit 1-4, including activities at 1- and 9-month between site visits
Secondary	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.	Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
Secondary	Levels of mutans streptococci (MS)	Secondary outcomes will be changes in levels of children's mutans streptococci (MS)	Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively