UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027702
Receipt No. R000030148
Scientific Title CREATING A HEALTHIER NUTRITION ENVIRONMENT IN SCHOOLS: THE HEALTH PROMOTING SCHOOL CANTEEN INTERVENTION
Date of disclosure of the study information 2017/06/21
Last modified on 2017/06/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title CREATING A HEALTHIER NUTRITION ENVIRONMENT IN SCHOOLS: THE HEALTH PROMOTING SCHOOL CANTEEN INTERVENTION
Acronym THE HEALTH PROMOTING SCHOOL CANTEEN INTERVENTION
Scientific Title CREATING A HEALTHIER NUTRITION ENVIRONMENT IN SCHOOLS: THE HEALTH PROMOTING SCHOOL CANTEEN INTERVENTION
Scientific Title:Acronym THE HEALTH PROMOTING SCHOOL CANTEEN INTERVENTION
Region
Asia(except Japan)

Condition
Condition Randomized control trial
Classification by specialty
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reduce the proportion of energy-dense foods and drinks sold in canteens of selected schools after the intervention
Basic objectives2 Others
Basic objectives -Others 1.To improve food choice behavior, nutrition knowledge and nutritional status of school children
2.To improve stakeholders (parents, teachers and canteen operators ) nutrition knowledge, attitudes and practices
3.To investigate predisposing, enabling and reinforcing, epidemiology, behavioral and environmental factors
4.To implement educational and behaviour change strategies in the intervention schools among children and stakeholders.
6.To evaluate process of the intervention programme based on predisposing, enabling and reinforcing factors six month post intervention in both intervention and control group.
7.To asses impact of the intervention on behavioral, environmental factors and sales of energy-dense foods and drinks six month post intervention in both intervention and control group.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes reduction in proportion of energy-dense foods and drinks in canteens of selected schools after the intervention
Key secondary outcomes 1. Improvement in food choice behavior, nutritional knowledge and nutritional status of school children

2. Improved stakeholders (parents, teachers and canteen operators ) nutrition knowledge, attitudes and practices

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention: The intervention consist of a multi-component diet and nutrition education over a 6-month to one-year period, which will comprise a self-help education module, seminars with audio-visual aids, monthly diet and weight management counseling. Development of the module will be based on the baseline data and the content will be verified by expert panels. New foods with reduced fat and sugar and increased fibre content appropriate for children will be developed and tested for nutritional content, safety and sensory evaluation will be carried out on children parents and canteen operators.

Control: Will received the intervention material after the trial is over
Interventions/Control_2 Intervention: The intervention consist of a multi-component diet and nutrition education over a 6-month to one-year period, which will comprise a self-help education module, seminars with audio-visual aids, monthly diet and weight management counseling. Development of the module will be based on the baseline data and the content will be verified by expert panels. New foods with reduced fat and sugar and increased fibre content appropriate for children will be developed and tested for nutritional content, safety and sensory evaluation will be carried out on children parents and canteen operators.

Control: Will received the intervention material after the trial is over
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
17 years-old >=
Gender Male and Female
Key inclusion criteria All primary school children from the selected schools with informed consent of the parents are eligible to participate in this study. Parents of selected children, teachers and canteen operators will also be included.

Key exclusion criteria Students in public exam classes
Target sample size 510

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name PROF DR MIRNALINI KANDIAH
Organization USCI UNIVERSITY
Division name DEPARTMENT OF FOOD SCIENCE & NUTRITION, FACULTY OF APPLIED SCIENCES
Zip code
Address NO 1 JALAN MENARA GADING, UCSI HEIGHTS 56000 CHERAS, KUALA LUMPUR, MALAYSIA
TEL 016-6662311
Email mirnalini@ucsiuniversity.edu.my

Public contact
Name of contact person
1st name
Middle name
Last name VAIDEHI ULAGANATHAN
Organization USCI University
Division name DEPARTMENT OF FOOD SCIENCE & NUTRITION, FACULTY OF APPLIED SCIENCES
Zip code
Address NO 1 JALAN MENARA GADING, UCSI HEIGHTS 56000 CHERAS, KUALA LUMPUR, MALAYSIA
TEL +60102215379
Homepage URL https://www.facebook.com/NuTeen.Malaysia/
Email vaisu_uma10@yahoo.com.my

Sponsor
Institute Centre of Excellence for Research, Value Innovation and Entrepreneurship (CERVIE)
Mezzanine Level, 3rd Floor, Block C (Academic Block)
UCSI University
Institute
Department

Funding Source
Organization MINISTRY OF SCIENCE, TECHNOLOGY AND INNOVATIONOF MALAYSIA (MOSTI)
Fund Secretariat
Planning Division
http://ernd.mosti.gov.my/eScience
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization MALAYSIAN

Other related organizations
Co-sponsor NONE
Name of secondary funder(s) NONE

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 06 Month 21 Day

Related information
URL releasing protocol http://www.nutriweb.org.my/publications/mjn0023_1/default.php
Publication of results Partially published

Result
URL related to results and publications http://www.nutriweb.org.my/publications/mjn0023_1/default.php
Number of participants that the trial has enrolled
Results
At baseline 924 students and respective parents, 254 teachers and 40 canteen operators answered the questionnaires. Obesity was found in 32% of students. Vegetable and fruit consumption was below 30% and 60% of students think that foods sold in canteen lack healthy food choices. Nutrition knowledge was low in students and moderate in teachers, parents and canteen staff. Over 40% of canteen food were energy-dense food. Well planned and sustainable interventions should be comprehensive and encompass theoretical models with active student and community involvement 
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
2014 Year 09 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2017 Year 05 Month 05 Day
Date of closure to data entry
2017 Year 12 Month 15 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 15 Day

Other
Other related information Total of 1000 students, respective parents and350 teachers was recruited during pre-intervention

Checklist on environment factor developed
- Canteen facilities
- Cleanliness
- Type of food sold and price

Management information
Registered date
2017 Year 06 Month 09 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030148

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.