Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 5 Years and 9 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Schools will be cluster randomized to the intervention or comparison group
Primary Purpose
Prevention
Masking
Single (Investigator)
Masking Description
For post measurements, all data collection staff will be blinded to the intervention status.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Shreela Sharma, PhD
713-500-9344
Shreela.V.Sharma@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.