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Motivational Techniques for Preventing Tooth Decay in Children (BTCF Trial)

N/A

Recruiting

Led By Karin Weber-Gasparoni, PhD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively

Awards & highlights

BTCF Trial Summary

This trial is researching if using motivational techniques, rather than just educating, can prevent early childhood caries (a painful and debilitating disease). If successful, it could help lower risk in low-income and minority families.

Who is the study for?

This trial is for pregnant women aged 18-45, enrolled in the WIC program, who are between 12 and 32 weeks into their pregnancy. They must understand English or Spanish and plan to stay in the area for at least 4 years. Women who give birth before the first study visit cannot participate.Check my eligibility

What is being tested?

The trial tests if motivational videos based on self-determination theory can improve oral health behaviors to prevent early childhood cavities. It compares these videos against traditional neutral messages from pregnancy until the child turns three.See study design

What are the potential side effects?

Since this intervention involves educational videos, there are no direct medical side effects expected. However, individual responses to behavioral change strategies may vary.

BTCF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively

This trial's timeline: 3 weeks for screening, Varies for treatment, and visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Caries Status

Secondary outcome measures

Children's oral health behavior questionnaire

Levels of dental plaque

Levels of mutans streptococci (MS)

+1 more

BTCF Trial Design

2Treatment groups

Experimental Treatment

Group I: SDTExperimental Treatment1 Intervention

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 II: ControlExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor

447 Previous Clinical Trials

879,088 Total Patients Enrolled

Karin Weber-Gasparoni, PhDPrincipal InvestigatorUniversity of Iowa

Media Library

Self-determination theory Clinical Trial Eligibility Overview. Trial Name: NCT05756413 — N/A

Self-determination theory 2023 Treatment Timeline for Medical Study. Trial Name: NCT05756413 — N/A

Tooth Decay Research Study Groups: Control, SDT

Tooth Decay Clinical Trial 2023: Self-determination theory Highlights & Side Effects. Trial Name: NCT05756413 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project have any age restrictions, particularly for individuals over 35?

"This clinical trial is recruiting participants who are aged 18 or older and less than 45 years of age."

Answered by AI

In how many different geographic locations is this trial being conducted?

"15 different research centres are currently administering this trial. These sites span from Belle Plaine to Cedar Rapids and Clinton, as well as a number of other locales. Those interested in enrolling should consider selecting the facility closest to them to reduce travel requirements."

Answered by AI

What is the largest participant capacity for this research endeavor?

"Confirmatively, clinicaltrials.gov states that this research is in the process of finding participants for its trial which was first created on March 1st 2023 and had been updated most recently on August 14th 2023. 634 patients are required across 15 different sites to fulfill the requirements of this study."

Answered by AI

Is recruitment currently underway for this clinical experiment?

"Affirmative. According to the information on clinicaltrials.gov, this research is actively recruiting 634 participants from 15 different sites since its initial posting on March 1st 2023 and most recently updated in August 14th of that year."

Answered by AI

Does my profile meet the requirements to join this clinical investigation?

"The trial is currently recruiting 634 individuals aged 18-45 suffering from tooth decay. In order to participate, applicants must be WIC participants between 12 and 32 weeks pregnant that are able to communicate in English or Spanish, plus have no plans of relocating within the next 4 years."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Birth to Three - Cavity Free

Karin Weber-Gasparoni 2023. "Birth to Three - Cavity Free". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05756413.