Trial Outcomes & Findings for A School-Based Intervention to Reduce Lyme Disease (NCT NCT00594997)
NCT ID: NCT00594997
Last Updated: 2025-10-03
Results Overview
Parents of children were asked at baseline to report any new case of Lyme Disease within the past 12 months. This question was asked again a year later after receiving the educational intervention was given. We then will compare the number of reported Lyme Disease cases at baseline to the number of Lyme disease cases reported a year later. New cases of Lyme Disease had to be confirmed by medical record review.
COMPLETED
NA
3570 participants
baseline - 1 year
2025-10-03
Participant Flow
Participant milestones
| Measure |
Education
Students who receive an educational intervention which consists of a 45 minute interactive presentation as well as a 30 minute health education entertainment by a juggler.
Education: Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer
|
Control
Students who fill out pre and post surveys and receive the intervention after the post-survey
Control (pre and post surveys): Students fill out a pre and post survey and then receive the same intervention given to the controls.
|
|---|---|---|
|
Overall Study
STARTED
|
1562
|
2008
|
|
Overall Study
COMPLETED
|
1562
|
2008
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A School-Based Intervention to Reduce Lyme Disease
Baseline characteristics by cohort
| Measure |
Education
n=1562 Participants
Students who receive an educational intervention which consists of a 45 minute interactive presentation as well as a 30 minute health education entertainment by a juggler.
Education: Students receive an educational intervention delivered by a member of our staff in conjunction with the teacher as well as a health education entertainer
|
Control
n=2008 Participants
Students who fill out pre and post surveys and receive the intervention after the post-survey
Control (pre and post surveys): Students fill out a pre and post survey and then receive the same intervention given to the controls.
|
Total
n=3570 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.1 years
STANDARD_DEVIATION 1.2 • n=99 Participants
|
9.1 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
9.1 years
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
822 Participants
n=99 Participants
|
1003 Participants
n=107 Participants
|
1825 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
740 Participants
n=99 Participants
|
1005 Participants
n=107 Participants
|
1745 Participants
n=206 Participants
|
|
Grade
Second Grade
|
335 participants
n=99 Participants
|
489 participants
n=107 Participants
|
824 participants
n=206 Participants
|
|
Grade
Third Grade
|
410 participants
n=99 Participants
|
514 participants
n=107 Participants
|
924 participants
n=206 Participants
|
|
Grade
Fourth Grade
|
422 participants
n=99 Participants
|
474 participants
n=107 Participants
|
896 participants
n=206 Participants
|
|
Grade
Fifth Grade
|
393 participants
n=99 Participants
|
528 participants
n=107 Participants
|
921 participants
n=206 Participants
|
|
Grade
Missing
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline - 1 yearPopulation: Number of Lyme cases reported in the intervention and control groups
Parents of children were asked at baseline to report any new case of Lyme Disease within the past 12 months. This question was asked again a year later after receiving the educational intervention was given. We then will compare the number of reported Lyme Disease cases at baseline to the number of Lyme disease cases reported a year later. New cases of Lyme Disease had to be confirmed by medical record review.
Outcome measures
| Measure |
Education
n=10 Participants
Number of reported incident cases of Lyme by parents of children who received a 45 minute educational intervention by a health educator.
|
Control
n=4 Participants
The number of incident cases of Lyme reported by parents of students in the control group. These students did not receive the educational intervention.
|
|---|---|---|
|
The Incidence of Lyme Disease Among Children and Families Living in an Endemic Area Using an Educational Intervention
|
1 Number of cases incident Lyme disease
|
1 Number of cases incident Lyme disease
|
SECONDARY outcome
Timeframe: baseline -1 yearPopulation: Composite knowledge score for intervention and control students post-intervention. Comparing the change in score between intervention and controls between pre and post evaluation.
Three outcome measures, knowledge of LD transmission, self reported tick bite precautionary behaviors and attitudes towards taking precautions were measured. A Lyme Disease knowledge score was created from totaling the number of correct answers on the 6 knowledge questions, ranging from 0-6. A score with a higher value indicated an increase in the desired behavior. These questions were asked before and after the intervention to compared the change from preintervention with postintervention between intervention and control students, adjusted for age, sex and pre-knowledge score. Precautionary behavior outcomes were graded on a linear scale quantifying the amount of practice.
Outcome measures
| Measure |
Education
n=1562 Participants
Number of reported incident cases of Lyme by parents of children who received a 45 minute educational intervention by a health educator.
|
Control
n=2008 Participants
The number of incident cases of Lyme reported by parents of students in the control group. These students did not receive the educational intervention.
|
|---|---|---|
|
The Educational Intervention Will Improve the Children's Self-confidence (Behavioral Self-efficacy), Intention to Perform, and Actual Practice of Lyme Disease Prevention Behaviors.
|
1.38 units on a scale
Standard Deviation 1.31
|
0.36 units on a scale
Standard Deviation 1.30
|
Adverse Events
Education
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place