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Trial registered on ANZCTR


Trial ID
ACTRN12612000397819
Ethics application status
Approved
Date submitted
30/03/2012
Date registered
10/04/2012
Date last updated
18/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brain-based learning and animated cartoons in health education
Scientific title
Effectiveness of Brain-Based Learning and Animated Cartoons for Enhancing Healthy Habits among School Children in Khon Kaen, Thailand
Secondary ID [1] 280252 0
'Nil'
Universal Trial Number (UTN)
U1111-1129-5405
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of a range of health problems (e.g. dental caries, obesity, various communicable diseases) by means of health education to improve healthy behaviours in children 286205 0
Condition category
Condition code
Mental Health 286416 286416 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 286441 286441 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brain-based learning (BBL), video compact disc presentation of animated cartoons (VCD), and conventional teaching ( control group).
The trial duration was 16 weeks The intervention for experimental group 1(Exp.gr.1: BBL+VCD) involved teachers inserting the BBL technique into regular classroom sessions for the students (at least 15 minutes every day) and then students watched a VCD animated cartoon. There was one cartoon story lasting 2-3 minutes for each of the Thai Ten Commandments for Health (TTCH), and new cartoon was used each day for 10 consecutive days. The students were able to repeat the same story as much as they wanted at the same day, and the cycle of one of the 10 VCD cartoons per day was repeated over the 16 week period of the trial. The intervention for experimental group 2 (Exp.gr.2: BBL only), was the same as for experimental group 1, but with the VCD component omitted. The intervention for experimental group 3 (Exp.gr. 3: VCD only) was the same as for experimental group 1, but with the BBL component omitted. The intervention for group 4 was the control condition in which children were exposed to the classroom teaching of the TTCH using conventional teaching methods (ie without either BBL or VCD) for 15 minutes every day for 16 weeks. In each of the 4 groups, the teaching of the TTCH was supervised by the usual classroom teacher.

1.The BBL technique included the following six features: 1) readiness - creating an environment that fully immerses learners in the learning experience through various physical activities; 2) relaxation - trying to eliminate fear in learners while maintaining a highly challenging environment; 3) brain gym - exercising the brain in conjunction with classical music for five minutes; 4) brain linkage - reviewing a previous experience and linking it to a new experience by asking questions; 5) active processing - allowing the learner to consolidate and internalize information for the sole purpose of practicing healthy habits; and 6) agreement inducing practice - asking the learners to promise to practice the healthy habits that they learned both at school and at home every day.

2. The Thai Ten Commandments for Health as follows:

1.Personal hygiene including clean clothes and dressing
2.Clean teeth thoroughly and do this every day
3.Wash hands before eating and after using the toilet
4. Eat food that is cooked, clean, and without hazardous chemicals; do not eat food mixed with hazardous colors
5. No smoking, no alcohol, no drugs, no gambling, and no unsafe sex
6. Build strong relationships within the family
7. Prevent accidents by being careful
8. Exercise regularly and see the doctor annually for a health check up
9. Keep good mental health
10. Take on responsibilities and do something beneficial for society

3.LCD projectors and computer screens or television sets as visual aids were provided for VCD cartoons at classrooms.
Intervention code [1] 284598 0
Behaviour
Intervention code [2] 284599 0
Prevention
Comparator / control treatment
Conventional teaching, the control group, the teachers lectured students about TTCH (at least 15 minutes every day for 16 weeks.
Control group
Active

Outcomes
Primary outcome [1] 286864 0
Improvements in knowledge and reported practice of healthy behaviours. A specially constructed self-report questionnaire, was used to assess the quantitative outcomes.
The name of this self-report questionnaire is "Self-evaluation practices of the Thai Ten Commandments for Health for students"
Timepoint [1] 286864 0
at 16 weeks after randomisation
Secondary outcome [1] 296835 0
no
Timepoint [1] 296835 0
no

Eligibility
Key inclusion criteria
The subjects were selected by a multi-stage sampling process in which the first stage was the identification of 40 medium-sized primary schools with similar numbers of students and teachers. A feasibility survey was then conducted to determine whether the schools were able and willing to participate in the study and, as a result, additional inclusion criteria were added: (1) the schools finally selected should not have BBL as a teaching technique, (2) they should not have used an LCD projector, computer screens or television sets as visual aids for teaching their students, and (3) the school administrators, students and their parents must consent to cooperate with the study requirements.
Minimum age
6 Years
Maximum age
9 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
School using brain-based learning and/or VCD animated cartoons of Thai Ten Commandments for Health

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Twenty-two schools met the criteria for inclusion in the study. Sixteen schools were then selected by simple random sampling, and four schools were randomly assigned to one of three experimental groups or the control group: 263 children in experimental Group 1 were exposed to the BBL in conjunction with VCD cartoons, 254 children in Group 2 were solely exposed to BBL, 295 children in Group 3 were exposed only to VCD cartoons, and 273 children served as a control group which was exposed only to conventional methods of teaching about TTCH. Allocation was concealed by the use of numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation of four schools to the three experimental groups and the single control group was done by simple randomization using procedures like drawing tickets in a raffle. All the school were given a number 1-16, and then four numbers drawn at random for each group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
no
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4233 0
Thailand
State/province [1] 4233 0
Khon Kaen Province

Funding & Sponsors
Funding source category [1] 285015 0
Government body
Name [1] 285015 0
Thai Health Promotion Foundation
Address [1] 285015 0
979/116-120 S.M.Tower Floor 34 Paholyothin Rd., Samsen Nai, Payathai, Bangkok 10400
Country [1] 285015 0
Thailand
Primary sponsor type
Government body
Name
Thai Health Promotion Foundation
Address
979/116-120 S.M.Tower Floor 34 Paholyothin Rd., Samsen Nai, Payathai, Bangkok 10400
Country
Thailand
Secondary sponsor category [1] 283878 0
None
Name [1] 283878 0
Address [1] 283878 0
Country [1] 283878 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287017 0
The Khon Kaen University Ethics Committee for Human Research
Ethics committee address [1] 287017 0
The Khon Kaen University Ethics Committee for Human Research Office, 17th Floor, Princess Mother Memorial Building, Faculty of Medicine, Khon Kaen University, Mitraphap Road, Khon Kaen, 40002
Ethics committee country [1] 287017 0
Thailand
Date submitted for ethics approval [1] 287017 0
Approval date [1] 287017 0
26/11/2008
Ethics approval number [1] 287017 0
HE510911

Summary
Brief summary
The results of the multiple comparison tests showed that, for knowledge, BBL+VCD was more effective than VCD on its own (p<0.01) and was not significantly better than BBL on its own (p=0.09). The educational impact of a set of VCD was not significant different from that of BBL in knowledge of healthy habits, and the addition of BBL to VCD made no significant did not improve the effectiveness of VCD in improving healthy practices. While the BBL process alone improved practice of healthy habits more than VCD did on its own (p<0.01). For both knowledge and practices, the children in all the experimental groups did better than those in the control group.
Trial website
no
Trial related presentations / publications
An oral presentation at Thailand Research Symposium 2011 on Aug 26-30, 2011, Bangkok, Thailand
Public notes

Contacts
Principal investigator
Name 34006 0
Address 34006 0
Country 34006 0
Phone 34006 0
Fax 34006 0
Email 34006 0
Contact person for public queries
Name 17253 0
Pannee Banchonhattekit
Address 17253 0
Department of Health Education. Faculty of Public Health, Khon Kaen University, Mittraphap Road, Muang District, Khon Kaen province, 40002
Country 17253 0
Thailand
Phone 17253 0
+66 4 336 2077
Fax 17253 0
+66 4 334 7058
Email 17253 0
panban@kku.ac.th
Contact person for scientific queries
Name 8181 0
Pannee Banchonhattekit
Address 8181 0
Department of Health Education. Faculty of Public Health, Khon Kaen University, Mittraphap Road, Muang District, Khon Kaen province, 40002
Country 8181 0
Thailand
Phone 8181 0
+66 4 336 2077
Fax 8181 0
+66 4 334 7058
Email 8181 0
panban@kku.ac.th