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Birth to Three - Cavity Free (BTCF)

Primary Purpose

Caries,Dental

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-determination theory
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries,Dental

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: WIC-participating pregnant women who are 18 to 45 years old Between 12 and 32 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

Sites / Locations

  • Anamosa WIC ClinicRecruiting
  • Belle Plaine WIC ClinicRecruiting
  • LCPH WIC ClinicRecruiting
  • Urban WIC ClinicRecruiting
  • Clinton WIC ClinicRecruiting
  • Columbus Junction WIC ClinicRecruiting
  • Davenport WIC ClinicRecruiting
  • CHC Edgerton ClinicRecruiting
  • Dewitt WIC ClinicRecruiting
  • Maquoketa WIC ClinicRecruiting
  • Marion WIC ClinicRecruiting
  • Monticello WIC ClinicRecruiting
  • Muscatine WIC ClinicRecruiting
  • Tipton WIC ClinicRecruiting
  • Vinton WIC ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

SDT

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Caries Status
The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions.
Caries Status
The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions.
Caries Status
The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions.

Secondary Outcome Measures

Maternal knowledge questionnaire
Secondary outcomes will be changes in maternal knowledge on oral health care
Children's oral health behavior questionnaire
Secondary outcomes will be changes in maternal oral health behaviors towards their children
Levels of dental plaque
Secondary outcomes will be changes in levels of children's dental plaque. Visible plaque will be assessed first and recorded as present or absent for the maxillary and mandibular incisors and molars. The number of maxillary and mandibular incisors and molars with plaque will also be recorded.
Levels of mutans streptococci (MS)
Secondary outcomes will be changes in levels of children's mutans streptococci (MS)

Full Information

First Posted
November 8, 2022
Last Updated
August 14, 2023
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT05756413
Brief Title
Birth to Three - Cavity Free
Acronym
BTCF
Official Title
Birth to Three - Cavity Free: Effectiveness of a Psychoeducational Intervention for ECC Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
The UH3 study is considered a Stage II research according to the NIH Stage Model and builds directly upon the rigor of our previous formative research work, including a study supported by R21 DE016483-02. The R21 study tested the effectiveness of an autonomy-supportive videotaped oral health message informed by the self-determination theory (SDT) as a preventive behavioral approach for ECC among WIC-enrolled 12- to 49-month old children and their mothers. This grant was exploratory in nature and did not allow our research team to have a control group. In order to test the study intervention against the standard dental educational brochures, funding was obtained through the University of Iowa (UI) College of Dentistry to recruit participants to a control group. This concurrent control group was recruited to facilitate future study planning, including estimation of effect sizes. Results from the R21 study provided evidence of the effectiveness of the SDT-framed autonomy-supportive videotaped intervention in changing several oral health behaviors for ECC prevention: increased children's daily brushing habits, use of fluoridated toothpaste, mother's lifting their children's lip to look for early signs of ECC, and compliance with the consumption of no more than 4 ounces of 100% juice daily. Additional behavioral changes included decreased nighttime feeding other than water, and reduced number of daily cariogenic snacks consumed. The future proposed UH3 study will improve upon our previous investigations in two ways. First, the investigators will enhance the expected effectiveness of our experimental manipulation by creating and implementing a more research-informed age targeted oral health message. Second, the UH3 mechanism will allow us to enhance our capacity to assess the effectiveness of the SDT-derived videotaped oral health message compared to a control group with an optimal, sufficiently powered sample size. The investigators believe they have a strong scientific foundation for this project based on the rigor of our prior research efforts. Our approach will have a broader impact in that it tests a low-cost behavioral intervention that can be used in WIC clinics and other public health settings across the nation. As such, the use of evidence-based autonomy-supportive messages could efficiently disseminate an important and effective health promotion message that has great generalizability and the potential to greatly reduce the burden of ECC among some of the most vulnerable populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries,Dental

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Principal investigator and clinical examiner will be blinded to group allocation
Allocation
Randomized
Enrollment
634 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SDT
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-determination theory
Intervention Description
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".
Primary Outcome Measure Information:
Title
Caries Status
Description
The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions.
Time Frame
Visits 2 when children are 12 months of age
Title
Caries Status
Description
The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions.
Time Frame
Visits 3 when children are 24 months of age
Title
Caries Status
Description
The primary outcome of interest is children's caries status, as measured by the number of decayed, missing or filled surfaces using the d1d2-3 mfs scoring method. Both d2-3 and d1 levels, derived from the d1d2-3mfs caries criteria, will be considered, reflecting numbers of affected (cavitated, missing due to caries or filled) surfaces with and without inclusion of non-cavitated (d1 "white spot") lesions.
Time Frame
Visits 4 when children are 36 months of age
Secondary Outcome Measure Information:
Title
Maternal knowledge questionnaire
Description
Secondary outcomes will be changes in maternal knowledge on oral health care
Time Frame
Visit 1-4, including activities at 1- and 9-month between site visits
Title
Children's oral health behavior questionnaire
Description
Secondary outcomes will be changes in maternal oral health behaviors towards their children
Time Frame
Visit 1-4, including activities at 1- and 9-month between site visits
Title
Levels of dental plaque
Description
Secondary outcomes will be changes in levels of children's dental plaque. Visible plaque will be assessed first and recorded as present or absent for the maxillary and mandibular incisors and molars. The number of maxillary and mandibular incisors and molars with plaque will also be recorded.
Time Frame
Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively
Title
Levels of mutans streptococci (MS)
Description
Secondary outcomes will be changes in levels of children's mutans streptococci (MS)
Time Frame
Visits 2, 3 and 4 when children are 12-, 24- and 36-months of age, respectively

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Pregnant mothers
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: WIC-participating pregnant women who are 18 to 45 years old Between 12 and 32 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Weber-Gasparoni, PhD
Phone
3196215874
Email
karin-weber@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Bowman-Reif, MS
Phone
3194674930
Email
jennifer-bowman-reif@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Weber-Gasparoni, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anamosa WIC Clinic
City
Anamosa
State/Province
Iowa
ZIP/Postal Code
52205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Strahan
Email
dstrahan@HACAP.ORG
Facility Name
Belle Plaine WIC Clinic
City
Belle Plaine
State/Province
Iowa
ZIP/Postal Code
52208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Strahan
Email
dstrahan@HACAP.ORG
Facility Name
LCPH WIC Clinic
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Strahan
Email
dstrahan@HACAP.ORG
Facility Name
Urban WIC Clinic
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Strahan
Email
dstrahan@HACAP.ORG
Facility Name
Clinton WIC Clinic
City
Clinton
State/Province
Iowa
ZIP/Postal Code
52732
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Kaczinski
Email
cynthia.kaczinski@hillcrest-fs.org
Facility Name
Columbus Junction WIC Clinic
City
Columbus Junction
State/Province
Iowa
ZIP/Postal Code
52738
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celesta Burton
Email
celesta.burton@caofseia.org
Facility Name
Davenport WIC Clinic
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maddy Radshaw
Email
mranshaw@chcqca.org
Facility Name
CHC Edgerton Clinic
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maddy Radshaw
Email
mranshaw@chcqca.org
Facility Name
Dewitt WIC Clinic
City
De Witt
State/Province
Iowa
ZIP/Postal Code
52742
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Kaczinski
Email
cynthia.kaczinski@hillcrest-fs.org
Facility Name
Maquoketa WIC Clinic
City
Maquoketa
State/Province
Iowa
ZIP/Postal Code
52060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Kaczinski
Email
cynthia.kaczinski@hillcrest-fs.org
Facility Name
Marion WIC Clinic
City
Marion
State/Province
Iowa
ZIP/Postal Code
52302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Strahan
Email
dstrahan@HACAP.ORG
Facility Name
Monticello WIC Clinic
City
Monticello
State/Province
Iowa
ZIP/Postal Code
52310
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Strahan
Email
dstrahan@HACAP.ORG
Facility Name
Muscatine WIC Clinic
City
Muscatine
State/Province
Iowa
ZIP/Postal Code
52761
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celesta Burton
Email
celesta.burton@caofseia.org
Facility Name
Tipton WIC Clinic
City
Tipton
State/Province
Iowa
ZIP/Postal Code
52772
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maddy Radshaw
Email
mranshaw@chcqca.org
Facility Name
Vinton WIC Clinic
City
Vinton
State/Province
Iowa
ZIP/Postal Code
52349
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Strahan
Email
dstrahan@HACAP.ORG

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study will comply with NIH Public Access Policy, which ensures that the public has access to the published results of NIH-funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central within 12 months upon publication. The research team will be responsible for developing publication procedures and resolving authorship issues. Manuscripts will be reviewed by all the co-authors before submission. Data will be shared no later than the acceptance for publication of the main findings from the final data set.

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Birth to Three - Cavity Free

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