UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046962 |
|---|---|
| Receipt number | R000053583 |
| Scientific Title | Home gardening programme for the improvement of vegetable consumption among urban poor children aged 9 to 12 years in Kuala Lumpur, Malaysia |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2022/02/21 15:10:30 |
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Basic information
Public title
Home gardening intervention and vegetable consumption among urban poor children in Malaysia.
Acronym
Home gardening intervention and vegetable consumption among urban poor children in Malaysia.
Scientific Title
Home gardening programme for the improvement of vegetable consumption among urban poor children aged 9 to 12 years in Kuala Lumpur, Malaysia
Scientific Title:Acronym
Home gardening programme for the improvement of vegetable consumption among urban poor children aged 9 to 12 years in Kuala Lumpur, Malaysia
Region
| Asia(except Japan) |
Condition
Condition
Low vegetable consumption
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the home gardening programme for the improvement of vegetable consumption and agricultural awareness of the urban poor children in Kuala Lumpur, Malaysia.
Basic objectives2
Others
Basic objectives -Others
a. To develop and test the reliability of a questionnaire that measures preferences, attitude, recognition, and knowledge towards vegetables and agricultural awareness of urban poor children.
b. To determine the consumption, preferences, attitude, recognition, and knowledge towards vegetables and agricultural awareness of urban poor children.
c. To determine the anthropometric status of the urban poor children.
d. To determine the association between the preferences, attitude, recognition, and knowledge towards vegetables and agricultural awareness with the consumption of vegetables and anthropometric status of urban poor children.
e. To develop a module and lesson plan of a home garden programme for urban poor children.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in vegetable consumption of the children after the intervention. Assessments will be conducted at three-time points: pre-intervention, post-intervention, and 3-month follow-up.
Key secondary outcomes
Change in anthropometric status and agricultural awareness among the children after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
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 group will undergo the home gardening intervention and nutrition education programme for 3 months (12 weeks). There are two main components of the intervention include (1) home gardening session and (2) nutrition education session. In total, the intervention will be conducted for 12 weeks with each session will take about 90 minutes.
Interventions/Control_2
The control group will not receive any gardening programme and nutrition education programme during the intervention period. Assessment will be conducted before the beginning of the programme (baseline assessment), after the final session of the intervention (post-intervention assessment), and 3 months after the intervention (follow-up assessment).
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
| 9 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Children living in selected PPR Flats Kuala Lumpur for at least 1 year
2) Aged 9-12 years
3) Healthy children with no physical and learning disabilities as confirmed by parents"
Key exclusion criteria
1) Children who are under any special diet or diet restrictions
2) Children who have chronic medical problems or special needs
3) Children from households with a functioning garden
Target sample size
134
Research contact person
Name of lead principal investigator
| 1st name | Satvinder |
| Middle name | Kaur |
| Last name | Nachata |
Organization
UCSI University
Division name
Faculty of Applied Sciences
Zip code
56000
Address
UCSI Heights, 1, Jalan Puncak Menara Gading, Taman Connaught, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
TEL
60391018880
satvinderkaur@ucsiuniversity.edu.my
Public contact
Name of contact person
| 1st name | Kai Ting |
| Middle name | Kai |
| Last name | Mok |
Organization
UCSI University
Division name
Faculty of Applied Sciences
Zip code
55300
Address
UCSI Heights, 1, Jalan Puncak Menara Gading, Taman Connaught, 56000 Cheras, Wilayah Persekutuan Kual
TEL
60391018880
Homepage URL
kaitingm@gmail.com
Sponsor or person
Institute
UCSI University
Institute
Department
Personal name
Funding Source
Organization
UCSI University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Malaysian
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
UCSI Institutional Ethics Committee
Address
UCSI Heights, 1, Jalan Puncak Menara Gading, Taman Connaught, 56000 Cheras, Wilayah Persekutuan Kual
Tel
60391018880
cervie@ucsiuniversity.edu.my
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
UCSI University (Kuala Lumpur, Malaysia)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 21 | Day |
Last modified on
| 2022 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053583
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