UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Healthy Lifestyle Program for primary school children in Batu Pahat District, Johor State, Malaysia
Title of the study (Brief title)	Healthy Lifestyle Program (HLP) for primary school children
Region	Asia(except Japan)

Condition
Condition	malnutrition, overweight and obesity
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of Healthy Lifestyle Program among primary school children in Batu Pahat district, Johor.
Basic objectives2	Others
Basic objectives -Others	1. To determine socio-demographic background among primary school children at baseline. 2. To determine the effectiveness of the Healthy Lifestyle Program in i) nutrition knowledge, attitude and practices ii) physical activity iii) dietary practices (dietary intake and eating behaviour) iv) sleep behaviour v) psychological distress (depression, anxiety and stress) vi) body composition (body weight status, waist circumference and body fat percent) vii) cognitive performance viii) health-related quality of life (HRQoL) between intervention and control groups before and after the intervention program. 3. To determine the changes of school staff nutrition knowledge, attitude and practices between intervention and control group before and after the intervention program. 4. To determine the changes of canteen staff nutrition knowledge among intervention group before and after the intervention program.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Changes of BMI-for-Age 2) Changes of nutrition knowledge, attitude and practice 3) Changes of physical activity 4) Changes of eating behaviour
Key secondary outcomes	1) Changes of Psychosocial distress 2) Changes of Cognitive performance 3) Changes of health-related quality of life

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
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 the intervention group, children will attend three comprehensive nutrition and health modules (17 topics) through Healthy Kids Camps and continue with three month school meal during recess in school canteen. This program implemented for three months.
Interventions/Control_2	Children in comparison group were not subjected to the intervention until the end of the period of study. Children in the comparison group attend a standard physical and health education class at least once a week.
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	7 years-old <=
Age-upper limit	11 years-old >=
Gender	Male and Female
Key inclusion criteria	Male and Female (aged 7 to 11, respectively) and have consent from parents.
Key exclusion criteria	-Students with obvious genetic disorders, such as down syndrome and attention deficit hyperactivity disorder (ADHD). -Children at Standard 6 -Children with learning disorder
Target sample size	696

Research contact person
Name of lead principal investigator	Chin Yit Siew
Organization	Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Puta Malaysia
Division name	Department of Nutrition and Dietetics
Address	Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
TEL	+603-89472680
Email	chinys@upm.edu.my

Public contact
Name of contact person	Chin Yit Siew
Organization	Faculty of Medicine and Health Sciences, Universiti Puta Malaysia
Division name	Department of Nutrition and Dietetics
Address	Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, UPM
TEL	+603-89472680
Homepage URL
Email	chinys@upm.edu.my

Sponsor
Institute	Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia.
Institute
Department

Funding Source
Organization	self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 06 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 07 Day
Anticipated trial start date	2018 Year 06 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 07 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037525