UMIN-CTR Clinical Trial

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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