Birth to Three - Cavity Free

NCT ID: NCT05756413

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 634 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2027-03-31

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.

Conditions

Caries,Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

SDT

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.

Group Type: EXPERIMENTAL

Self-determination theory

Intervention Type: BEHAVIORAL

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".

Control

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.

Group Type: OTHER

Self-determination theory

Intervention Type: BEHAVIORAL

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".

Interventions

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".

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Karin Weber-Gasparoni

Professor and Chair Pediatric Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Weber-Gasparoni, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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

Davenport WIC Clinic

Davenport, Iowa, United States

CHC Edgerton 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, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1UG3DE029443-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202002391

Identifier Type: -

Identifier Source: org_study_id