ACTIVE_NOT_RECRUITING

Birth to Three - Cavity Free

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-03-01
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05756413

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * WIC-participating pregnant women who are 18 to 45 years old
  2. * Between 12 and 36 weeks of the gestational period
  3. * Able to speak, understand and read English or Spanish
  4. * No intention to move away in the next 4 years
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Karin Weber-Gasparoni, PhD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

Anamosa WIC Clinic
Anamosa, Iowa, 52205
United States
Belle Plaine WIC Clinic
Belle Plaine, Iowa, 52208
United States
LCPH WIC Clinic
Cedar Rapids, Iowa, 52401
United States
Urban WIC Clinic
Cedar Rapids, Iowa, 52403
United States
Clinton WIC Clinic
Clinton, Iowa, 52732
United States
Columbus Junction WIC Clinic
Columbus Junction, Iowa, 52738
United States
Davenport WIC Clinic
Davenport, Iowa, 52801
United States
CHC Edgerton Clinic
Davenport, Iowa, 52803
United States
Dewitt WIC Clinic
De Witt, Iowa, 52742
United States
Johnson County WIC
Iowa City, Iowa, 52246
United States
Maquoketa WIC Clinic
Maquoketa, Iowa, 52060
United States
Marion WIC Clinic
Marion, Iowa, 52302
United States
Monticello WIC Clinic
Monticello, Iowa, 52310
United States
Muscatine WIC Clinic
Muscatine, Iowa, 52761
United States
Tipton WIC Clinic
Tipton, Iowa, 52772
United States
Vinton WIC Clinic
Vinton, Iowa, 52349
United States

Collaborators and Investigators

Sponsor: University of Iowa

  • Karin Weber-Gasparoni, PhD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Caries,Dental