CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

NCT04632667 | Completed

• 1 other identifier: HSC-SPH-19-0838
• Study Type: interventional
• Target: 1,084
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries,Dental

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (22)

• Number of children with good oral hygiene as measured by the child plaque index

  Baseline

• Number of children with good oral hygiene as measured by the child plaque index

  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

  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

  end of year 3 about 33 months form start of intervention

• Child dietary intake as measured by the Block food frequency screener

  Baseline

Study Arms (2)

Comparison School Group

ACTIVE COMPARATOR

Behavioral: Comparison School Group

Intervention School Group

EXPERIMENTAL

Behavioral: Intervention School Group

Interventions

Comparison School Group BEHAVIORAL

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.

Comparison School Group

Intervention School Group BEHAVIORAL

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.

Intervention School Group

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 36387989 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Shreela Sharma, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: For post measurements, all data collection staff will be blinded to the intervention status.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Schools will be cluster randomized to the intervention or comparison group

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: November 17, 2020
• Study Start: February 5, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)