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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026055
Receipt No. 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

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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
Email 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
Email chinys@upm.edu.my

Sponsor
Institute Nestle Products Pte Ltd under Nestle Healthy Kids project
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029907

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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