UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026055 |
|---|---|
| Receipt number | R000029907 |
| Scientific Title | Teacher-led Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia by using the "Healthy Eating and Be Active among Teens" (HEBAT) modules |
| Date of disclosure of the study information | 2017/02/11 |
| Last modified on | 2017/02/08 16:41:50 |
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Basic information
Public title
Teacher-led Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia by using the "Healthy Eating and Be Active among Teens" (HEBAT) modules
Acronym
Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia
Scientific Title
Teacher-led Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia by using the "Healthy Eating and Be Active among Teens" (HEBAT) modules
Scientific Title:Acronym
Healthy Lifestyle Program for adolescents living in day-school hostels in Malaysia
Region
| Asia(except Japan) |
Condition
Condition
Healthy eating, Active lifestyle, Healthy body weight
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To promote healthy lifestyle (healthy eating and active lifestyle) among Malaysian adolescents living in day-school hostels
Basic objectives2
Others
Basic objectives -Others
To evaluate the effectiveness of the "Healthy Lifestyle Program" among adolescents by determining the difference in:
- Body composition (BMI-for-age, waist circumference, body fat percentage)
- Knowledge, attitude and practice of healthy lifestyle
- Eating behaviors
- Physical Activity
- Body image
- Psychological well-being
- Health related quality of life
before and after the intervention program
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in:
- Body composition (BMI-for-age, waist circumference, body fat percentage)
- Knowledge, attitude and practice of healthy lifestyle
before and after the intervention program
Key secondary outcomes
Changes in:
- Eating behaviors
- Physical Activity
- Body image
- Psychological well-being
- Health related quality of life
before and after the intervention program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
In intervention group, teachers were trained to use the HEBAT modules to educate the students in practicing healthy lifestyle. The HEBAT modules focused on healthy eating and active living that are the important components in energy balance. The intervention is divided to 2 phases, with 4 intervention topics in Phase 1 and 6 intervention topicsin Phase 2.
Interventions/Control_2
In the control group, no intervention is given to both teachers and students. Students received standard physical education at schools. They will receive the education materials from the Healthy Lifestyle Program after the intervention is completed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 13 | years-old | <= |
Age-upper limit
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Form 1 adolescents who are living in day-school hostels
Key exclusion criteria
Adolescent who are physically disabled and have learning disability
Target sample size
4277
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chin Yit Siew |
Organization
Universiti Putra Malaysia
Division name
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences
Zip code
Address
Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia
TEL
+60389472680
chinys@upm.edu.my
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chin Yit Siew |
Organization
Universiti Putra Malaysia
Division name
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences
Zip code
Address
Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia
TEL
+60389472680
Homepage URL
chinys@upm.edu.my
Sponsor or person
Institute
Nestle Products Pte Ltd under Nestle Healthy Kids project
Institute
Department
Personal name
Funding Source
Organization
Nestle Products Pte Ltd under Nestle Healthy Kids project
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Malaysia
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 08 | Day |
Last modified on
| 2017 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029907
