CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1084 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-05

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Caries,Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Schools will be cluster randomized to the intervention or comparison group

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

For post measurements, all data collection staff will be blinded to the intervention status.

Study Groups

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Comparison School Group

Group Type ACTIVE_COMPARATOR

Comparison School Group

Intervention Type 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.

Intervention School Group

Group Type EXPERIMENTAL

Intervention School Group

Intervention Type 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.

Interventions

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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 Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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