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CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

Primary Purpose

Caries,Dental

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comparison School Group
Intervention School Group
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries,Dental

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For schools:

  • greater than 75% of the children enrolled in the dree/reduced school lunch program.
  • enrolling children in grade K in the 2021-2022 school year.
  • agree to implement the CATCH Healthy Smiles program and agreed to participate in the measurements

For parent and child to participate in the measures:

  • ability of the parent to speak and read in English or Spanish at the 4th grade level,
  • child enrolled in the participating school in grade K in the 2021-2022 school year
  • child ability to participate in the regular activities at the school

Exclusion Criteria:

-No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Comparison School Group

Intervention School Group

Arm Description

Outcomes

Primary Outcome Measures

Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)

Secondary Outcome Measures

Number of children with good oral hygiene as measured by the child plaque index
The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
Number of children with good oral hygiene as measured by the child plaque index
The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
Number of children with good oral hygiene as measured by the child plaque index
The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
Number of children with good oral hygiene as measured by the child plaque index
The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
Child dietary intake as measured by the Block food frequency screener
This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
Child dietary intake as measured by the Block food frequency screener
This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
Child dietary intake as measured by the Block food frequency screener
This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
Child dietary intake as measured by the Block food frequency screener
This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Number of times a child brushes their teeth a day
Number of times a child brushes their teeth a day
Number of times a child brushes their teeth a day
Number of times a child brushes their teeth a day
Change in Body Mass Index (BMI)
Child height and weight measured at the school using stadiometers and digital scales respectively.
Change in Child Oral health quality of life measured using parent self-report surveys
Frequency of flossing teeth for the child measured using parent self-report surveys
Frequency of flossing teeth for the child measured using parent self-report surveys
Frequency of flossing teeth for the child measured using parent self-report surveys
Frequency of flossing teeth for the child measured using parent self-report surveys

Full Information

First Posted
October 12, 2020
Last Updated
June 9, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT04632667
Brief Title
CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial
Official Title
CATCH Healthy Smiles: A Cluster-RCT of an Elementary School Oral Health Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 5, 2022 (Actual)
Primary Completion Date
April 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to clinically evaluate the effects of a school-based behavioral intervention, CATCH Healthy Smiles, to reduce the risk of dental caries in a cohort of kindergarten through 2nd grade (K-2) children serving low-income, ethnically-diverse children,to determine the impact of CATCH Healthy Smiles on child behavioral, psychosocial, and environmental outcomes beginning in K through 2nd grade, compared to children in the control schools and to examine the extent to which the child behavioral, psychosocial, and environmental factors mediate the improvements in child caries risk.

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
Model Description
Schools will be cluster randomized to the intervention or comparison group
Masking
Investigator
Masking Description
For post measurements, all data collection staff will be blinded to the intervention status.
Allocation
Randomized
Enrollment
1066 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Comparison School Group
Arm Type
Active Comparator
Arm Title
Intervention School Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Comparison School Group
Intervention Description
All control schools will receive training and materials for the CATCH sun safety curriculum. Ray and the Sunbeatables®: A Sun Safety Curriculum is an evidence-based curriculum educates children, parents and teachers about sun protection and promotes sun safety behaviors in an effort to reduce children's lifetime risk of developing skin cancer. Training will be conducted with booster trainings yearly.
Intervention Type
Behavioral
Intervention Name(s)
Intervention School Group
Intervention Description
This intervention includes toothbrushing which will be implemented as a daily activity to develop skills and technique,classroom curriculum, which includes theory-based interactive lessons on oral health care,the physical education component consisting of an activity box containing different structured physical activities that will integrate the nutrition and oral health education messages, all cafeteria-based intervention materials including the "tooth friendly" Eat Smart guide, signage, nutrition labeling, menu planning and labeling using the tooth-friendly Go-Slow-Whoa CATCH terminology will be provided to the food service staff that is displayed across the cafeteria and sent home to parents and parents will be provided with tools and tips for maintaining oral health with website resources,parent-child homework activities, send-home infographics on dental care, parent-monitored tracking of child oral health,family fun nights in schools, and social media.
Primary Outcome Measure Information:
Title
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Time Frame
Baseline(beginning of kindergarten)
Title
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Time Frame
end of year 1(Kindergarten)
Title
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Time Frame
end of year 2(first grade)
Title
number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Time Frame
end of year 3( second grade)
Secondary Outcome Measure Information:
Title
Number of children with good oral hygiene as measured by the child plaque index
Description
The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
Time Frame
Baseline
Title
Number of children with good oral hygiene as measured by the child plaque index
Description
The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
Time Frame
end of year 1 about 9 months form start of intervention
Title
Number of children with good oral hygiene as measured by the child plaque index
Description
The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
Time Frame
end of year 2 about 23 months from start of intervention
Title
Number of children with good oral hygiene as measured by the child plaque index
Description
The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
Time Frame
end of year 3 about 33 months form start of intervention
Title
Child dietary intake as measured by the Block food frequency screener
Description
This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
Time Frame
Baseline
Title
Child dietary intake as measured by the Block food frequency screener
Description
This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
Time Frame
end of year 1
Title
Child dietary intake as measured by the Block food frequency screener
Description
This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
Time Frame
end of year 2
Title
Child dietary intake as measured by the Block food frequency screener
Description
This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
Time Frame
end of year 3
Title
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Time Frame
Baseline
Title
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Time Frame
end of year 1 about 9 months from start of intervention
Title
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Time Frame
End of year 2 about 23 months from start of intervention
Title
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Time Frame
End of year 3 about 33 months from start of intervention
Title
Number of times a child brushes their teeth a day
Time Frame
Baseline
Title
Number of times a child brushes their teeth a day
Time Frame
end of year 1 about 9 months from start of intervention
Title
Number of times a child brushes their teeth a day
Time Frame
End of year 2 about 23 months from start of intervention
Title
Number of times a child brushes their teeth a day
Time Frame
End of year 3 about 33 months from start of intervention
Title
Change in Body Mass Index (BMI)
Description
Child height and weight measured at the school using stadiometers and digital scales respectively.
Time Frame
baseline, end of Year 1, Year 2 and Year 3
Title
Change in Child Oral health quality of life measured using parent self-report surveys
Time Frame
baseline, end of Year 1, Year 2 and Year 3
Title
Frequency of flossing teeth for the child measured using parent self-report surveys
Time Frame
Baseline
Title
Frequency of flossing teeth for the child measured using parent self-report surveys
Time Frame
end of year 1
Title
Frequency of flossing teeth for the child measured using parent self-report surveys
Time Frame
end of year 2
Title
Frequency of flossing teeth for the child measured using parent self-report surveys
Time Frame
end of year 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For schools: greater than 75% of the children enrolled in the dree/reduced school lunch program. enrolling children in grade K in the 2021-2022 school year. agree to implement the CATCH Healthy Smiles program and agreed to participate in the measurements For parent and child to participate in the measures: ability of the parent to speak and read in English or Spanish at the 4th grade level, child enrolled in the participating school in grade K in the 2021-2022 school year child ability to participate in the regular activities at the school Exclusion Criteria: -No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shreela Sharma, PhD
Phone
(713) 500-9344
Email
Shreela.V.Sharma@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ru-Jye Chuang, DrPH
Phone
(713) 500-9383
Email
Ru-Jye.Chuang@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shreela Sharma, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shreela Sharma, PhD
Phone
713-500-9344
Email
Shreela.V.Sharma@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Ru-Jye Chuang, DrPh
Phone
(713) 500-9383
Email
Ru-Jye.Chuang@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36387989
Citation
Chuang RJ, Byrd-Williams C, Yamal JM, Johnson K, Kelder S, Nelson S, Mofleh D, Sharma SV. Design for a cluster randomized controlled trial to evaluate the effects of the CATCH Healthy Smiles school-based oral health promotion intervention among elementary school children. Contemp Clin Trials Commun. 2022 Nov 5;30:101033. doi: 10.1016/j.conctc.2022.101033. eCollection 2022 Dec.
Results Reference
derived

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CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

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