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ACTIVE NOT RECRUITING
NCT05756413
NA

Birth to Three - Cavity Free

Sponsor: University of Iowa

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

634

Start Date

2023-03-01

Completion Date

2027-03-31

Last Updated

2025-12-03

Healthy Volunteers

Yes

Conditions

Interventions

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 (16)

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