This trial is no longer recruiting

Recruitment for this study has ended, so applications are closed. You can still read the trial details, or browse similar trials that are currently recruiting.

Not recruiting

CATCH Healthy Smiles

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04632667

Conditions

Caries,Dental

Eligibility Criteria

Sex: All

Age: 5 - 9

Healthy Volunteers: Not accepted

Interventions

Comparison School Group

Intervention School Group

Study Details

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

Study ID

NCT04632667

Start date

Feb 5, 2022

Status verified date

Jun, 2022

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 9

Healthy Volunteers: Not accepted

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 Design

Enrollment

1066 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Comparison School Group

experimental: Intervention School Group

Interventions

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.

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.

Primary outcome measure

  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Shreela Sharma, PhD

(713) 500-9344Shreela.V.Sharma@uth.tmc.edu

Ru-Jye Chuang, DrPH

(713) 500-9383Ru-Jye.Chuang@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Shreela Sharma, PhD

713-500-9344Shreela.V.Sharma@uth.tmc.edu

Ru-Jye Chuang, DrPh

(713) 500-9383Ru-Jye.Chuang@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jun 14, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2022-06-14.