Clinical trial NCT04632667: CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial
Official title: CATCH Healthy Smiles: A Cluster-RCT of an Elementary School Oral Health Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caries,Dental
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2020-11-17
Enrollment: 1066
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Schools will be cluster randomized to the intervention or comparison group
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
timeFrame: Baseline(beginning of kindergarten)
measure: Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
timeFrame: end of year 1(Kindergarten)
measure: Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
timeFrame: end of year 2(first grade)
measure: number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
timeFrame: end of year 3( second grade)
Secondary outcomes:
measure: Number of children with good oral hygiene as measured by the child plaque index
timeFrame: Baseline
measure: Number of children with good oral hygiene as measured by the child plaque index
timeFrame: end of year 1 about 9 months form start of intervention
measure: Number of children with good oral hygiene as measured by the child plaque index
timeFrame: end of year 2 about 23 months from start of intervention
measure: Number of children with good oral hygiene as measured by the child plaque index
timeFrame: end of year 3 about 33 months form start of intervention
measure: Child dietary intake as measured by the Block food frequency screener
timeFrame: Baseline
measure: Child dietary intake as measured by the Block food frequency screener
timeFrame: end of year 1
measure: Child dietary intake as measured by the Block food frequency screener
timeFrame: end of year 2
measure: Child dietary intake as measured by the Block food frequency screener
timeFrame: end of year 3
measure: Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
timeFrame: Baseline
measure: Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
timeFrame: end of year 1 about 9 months from start of intervention
measure: Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
timeFrame: End of year 2 about 23 months from start of intervention
measure: Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
timeFrame: End of year 3 about 33 months from start of intervention
measure: Number of times a child brushes their teeth a day
timeFrame: Baseline
measure: Number of times a child brushes their teeth a day
timeFrame: end of year 1 about 9 months from start of intervention
measure: Number of times a child brushes their teeth a day
timeFrame: End of year 2 about 23 months from start of intervention
measure: Number of times a child brushes their teeth a day
timeFrame: End of year 3 about 33 months from start of intervention
measure: Change in Body Mass Index (BMI)
timeFrame: baseline, end of Year 1, Year 2 and Year 3
measure: Change in Child Oral health quality of life measured using parent self-report surveys
timeFrame: baseline, end of Year 1, Year 2 and Year 3
measure: Frequency of flossing teeth for the child measured using parent self-report surveys
timeFrame: Baseline
measure: Frequency of flossing teeth for the child measured using parent self-report surveys
timeFrame: end of year 1
measure: Frequency of flossing teeth for the child measured using parent self-report surveys
timeFrame: end of year 2
measure: Frequency of flossing teeth for the child measured using parent self-report surveys
timeFrame: end of year 3
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Shreela Sharma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.