๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-17

Birth to Three - Cavity Free (NCT05756413)

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

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic ๐Ÿง  Behavioral & Psychological Program Sponsor: University of Iowa

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Anamosa WIC Clinic โ€” Anamosa, Iowa

Age range: 18 Years to 45 Years

๐Ÿงช Interventions in This Study

  • Self-determination theory (BEHAVIORAL)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (16 Sites)

  • Anamosa WIC Clinic โ€” Anamosa, Iowa
  • Belle Plaine WIC Clinic โ€” Belle Plaine, Iowa
  • LCPH WIC Clinic โ€” Cedar Rapids, Iowa
  • Urban WIC Clinic โ€” Cedar Rapids, Iowa
  • Clinton WIC Clinic โ€” Clinton, Iowa
  • Columbus Junction WIC Clinic โ€” Columbus Junction, Iowa
  • Davenport WIC Clinic โ€” Davenport, Iowa
  • CHC Edgerton Clinic โ€” Davenport, Iowa
  • Dewitt WIC Clinic โ€” De Witt, Iowa
  • Johnson County WIC โ€” Iowa City, Iowa
  • Maquoketa WIC Clinic โ€” Maquoketa, Iowa
  • Marion WIC Clinic โ€” Marion, Iowa
  • Monticello WIC Clinic โ€” Monticello, Iowa
  • Muscatine WIC Clinic โ€” Muscatine, Iowa
  • Tipton WIC Clinic โ€” Tipton, Iowa
  • Vinton WIC Clinic โ€” Vinton, Iowa

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Caries,Dental clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—