Clinical trial NCT05756413: Birth to Three - Cavity Free
Official title: Birth to Three - Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

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

Primary outcomes:
measure: Caries Status
timeFrame: Visits 2 when children are 12 months of age
measure: Caries Status
timeFrame: Visits 3 when children are 24 months of age
measure: Caries Status
timeFrame: Visits 4 when children are 36 months of age
Secondary outcomes:
measure: Maternal knowledge questionnaire
timeFrame: Visit 1-4, including activities at 1- and 9-month between site visits
measure: Children's oral health behavior questionnaire
timeFrame: Visit 1-4, including activities at 1- and 9-month between site visits
measure: Levels of dental plaque
timeFrame: Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
measure: Levels of mutans streptococci (MS)
timeFrame: Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
Other outcomes:
Locations:
city: Anamosa
country: United States
facility: Anamosa WIC Clinic
state: Iowa
city: Belle Plaine
country: United States
facility: Belle Plaine WIC Clinic
state: Iowa
city: Cedar Rapids
country: United States
facility: LCPH WIC Clinic
state: Iowa
city: Cedar Rapids
country: United States
facility: Urban WIC Clinic
state: Iowa
city: Clinton
country: United States
facility: Clinton WIC Clinic
state: Iowa
city: Columbus Junction
country: United States
facility: Columbus Junction WIC Clinic
state: Iowa
city: Davenport
country: United States
facility: Davenport WIC Clinic
state: Iowa
city: Davenport
country: United States
facility: CHC Edgerton Clinic
state: Iowa
city: De Witt
country: United States
facility: Dewitt WIC Clinic
state: Iowa
city: Iowa City
country: United States
facility: Johnson County WIC
state: Iowa
city: Maquoketa
country: United States
facility: Maquoketa WIC Clinic
state: Iowa
city: Marion
country: United States
facility: Marion WIC Clinic
state: Iowa
city: Monticello
country: United States
facility: Monticello WIC Clinic
state: Iowa
city: Muscatine
country: United States
facility: Muscatine WIC Clinic
state: Iowa
city: Tipton
country: United States
facility: Tipton WIC Clinic
state: Iowa
city: Vinton
country: United States
facility: Vinton WIC Clinic
state: Iowa
Study officials:
affiliation: University of Iowa
name: Karin Weber-Gasparoni, PhD
role: PRINCIPAL_INVESTIGATOR
References: