UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027702 |
|---|---|
| Receipt number | 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 16:25:58 |
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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
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/
vaisu_uma10@yahoo.com.my
Sponsor or person
Institute
Centre of Excellence for Research, Value Innovation and Entrepreneurship (CERVIE)
Mezzanine Level, 3rd Floor, Block C (Academic Block)
UCSI University
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
