Birth to Three - Cavity Free
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.
Conditions:
🦠 Caries,Dental
🗓️ Study Start (Actual) 1 March 2023
🗓️ Primary Completion (Estimated) 31 March 2027
✅ Study Completion (Estimated) 31 March 2027
👥 Enrollment (Estimated) 634
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Anamosa, Iowa, United States
📍 Belle Plaine, Iowa, United States
📍 Cedar Rapids, Iowa, United States
📍 Cedar Rapids, Iowa, United States
📍 Clinton, Iowa, United States
📍 Columbus Junction, Iowa, United States
📍 Davenport, Iowa, United States
📍 Davenport, Iowa, United States
📍 De Witt, Iowa, United States
📍 Iowa City, Iowa, United States
📍 Maquoketa, Iowa, United States
📍 Marion, Iowa, United States
📍 Monticello, Iowa, United States
📍 Muscatine, Iowa, United States
📍 Tipton, Iowa, United States
📍 Vinton, Iowa, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 45 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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

  • First Submitted 8 November 2022
  • First Submitted that Met QC Criteria 23 February 2023
  • First Posted 6 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 March 2024
  • Last Update Posted 26 March 2024
  • Last Verified August 2023