UMIN-CTR Clinical Trial

Public title

Evaluation of Healthy Lifestyle Program for primary school children in Batu Pahat District, Johor State, Malaysia

Acronym

Healthy Lifestyle Program (HLP) for primary school children

Scientific Title

Evaluation of Healthy Lifestyle Program for primary school children in Batu Pahat District, Johor State, Malaysia

Scientific Title:Acronym

Healthy Lifestyle Program (HLP) for primary school children

Region

Asia(except Japan)

Condition

malnutrition, overweight and obesity

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	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

Zip code

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

Name of contact person

1st name
Middle name
Last name	Chin Yit Siew

Organization

Faculty of Medicine and Health Sciences, Universiti Puta Malaysia

Division name

Department of Nutrition and Dietetics

Zip code

Address

Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, UPM

TEL

+603-89472680

Homepage URL

Email

chinys@upm.edu.my

Institute

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

Institute

Department

Personal name

Organization

self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

06

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

06

Month

07

Day

Date of IRB

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

Other related information

Registered date

2018

Year

06

Month

07

Day

Last modified on

2018

Year

06

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037525