CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

CATCH Healthy Smiles: A Cluster-RCT of an Elementary School Oral Health Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Caries,Dental
• Intervention / Treatment: Behavioral: Comparison School Group; Behavioral: Intervention School Group

• Study Type: Interventional
• Enrollment (Anticipated): 1066
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shreela Sharma, PhD; Phone Number: (713) 500-9344; Email: Shreela.V.Sharma@uth.tmc.edu
• Study Contact Backup: Name: Ru-Jye Chuang, DrPh; Phone Number: (713) 500-9383; Email: Ru-Jye.Chuang@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Ru-Jye Chuang, DrPh; Phone Number: (713) 500-9383; Email: Ru-Jye.Chuang@uth.tmc.edu
      • Contact: Shreela Sharma, PhD; Phone Number: 713-500-9344; Email: Shreela.V.Sharma@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Comparison School Group	Behavioral: Comparison School Group; 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.
Experimental: Intervention School Group	Behavioral: Intervention School Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)	Baseline(beginning of kindergarten)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)	end of year 1(Kindergarten)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)	end of year 2(first grade)
number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)	end of year 3( second grade)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	end of year 1 about 9 months form start of intervention
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.	end of year 2 about 23 months from start of intervention
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.	end of year 3 about 33 months form start of intervention
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	Baseline
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	end of year 1
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	end of year 2
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	end of year 3
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys		Baseline
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys		end of year 1 about 9 months from start of intervention
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys		End of year 2 about 23 months from start of intervention
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys		End of year 3 about 33 months from start of intervention
Number of times a child brushes their teeth a day		Baseline
Number of times a child brushes their teeth a day		end of year 1 about 9 months from start of intervention
Number of times a child brushes their teeth a day		End of year 2 about 23 months from start of intervention
Number of times a child brushes their teeth a day		End of year 3 about 33 months from start of intervention
Change in Body Mass Index (BMI)	Child height and weight measured at the school using stadiometers and digital scales respectively.	baseline, end of Year 1, Year 2 and Year 3
Change in Child Oral health quality of life measured using parent self-report surveys		baseline, end of Year 1, Year 2 and Year 3
Frequency of flossing teeth for the child measured using parent self-report surveys		Baseline
Frequency of flossing teeth for the child measured using parent self-report surveys		end of year 1
Frequency of flossing teeth for the child measured using parent self-report surveys		end of year 2
Frequency of flossing teeth for the child measured using parent self-report surveys		end of year 3

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Shreela Sharma, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2022
• Primary Completion (Anticipated): April 30, 2026
• Study Completion (Anticipated): April 30, 2026

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: HSC-SPH-19-0838

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No