To evaluate the effectiveness of a hands-on healthy meal preparation intervention on changes of psychosocial factors, home food environment and anthropometric measures among children
Design
Parallel, single-blind, school-based randomized-controlled trial with target sample size of 96 children.
Settings and conduct
Study will be conducted in schools in Kuala Lumpur, Malaysia. Stratified random sampling will be used in which one out of the total of three zones in Kuala Lumpur, Malaysia will be randomly selected. Then simple random sampling will be used whereby two primary schools will be randomly selected from the randomly selected zone. Both schools will then be randomly assigned to either intervention or control group. Finally, we will randomly select 48 children from each school. Participants will not know if there are in the intervention or control group.
Participants/Inclusion and exclusion criteria
Inclusion:
Malaysian children aged 9-11
Exclusion:
Children with any co-morbidity/learning disabilities
Children with food allergies (eg: wheat/gluten, dairy, or peanuts)
Intervention groups
Hands-on healthy meal preparation focusing on various food groups
Main outcome variables
Knowledge, attitude, practice and self-efficacy of healthy meal preparation.
Home food availability.
Anthropometric measures (BMI z-score, waist circumference, body fat %).
General information
Reason for update
Acronym
KidChen (Kids in Kitchen)
IRCT registration information
IRCT registration number:IRCT20190626044024N1
Registration date:2019-08-05, 1398/05/14
Registration timing:prospective
Last update:2019-08-05, 1398/05/14
Update count:0
Registration date
2019-08-05, 1398/05/14
Registrant information
Name
Choon Ming Ng
Name of organization / entity
UCSI University
Country
Malaysia
Phone
+60 3-9101 8882
Email address
ngchoonming23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-26, 1398/06/04
Expected recruitment end date
2019-09-02, 1398/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
KidChen Study: Randomized-controlled trial of experiential healthy meal preparation among children in improving nutritional outcomes
Public title
Hands-on healthy meal preparation in improving children's nutritional outcomes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Malaysian children aged 9-11.
Able to read, write and understand English/Malay language.
Children that voluntarily participate, with their parent’s consent.
Exclusion criteria:
Children with food allergies (eg: wheat/gluten, dairy, or peanuts)
Children with any serious co-morbidity/learning disabilities
Age
From 10 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified random sampling will be used in which one out of the total of three zones in Kuala Lumpur, Malaysia will be randomly selected. Then simple random sampling will be used whereby two primary schools will be randomly selected from the randomly selected zone. Both schools will then be randomly assigned to either intervention or control group. Finally, we will randomly select 48 children from each school. For randomization, we will use the Research Randomizer.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be blinded in the study. Children will not know whether they are in intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Medical Research and Ethics Committee (MREC), Malaysia
Street address
Kompleks Institut Kesihatan Negara Blok A, No 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170 Shah Alam, Selangor.
City
Selangor
Postal code
40170
Approval date
2018-05-04, 1397/02/14
Ethics committee reference number
NMRR-18-725-41268, KKM/NIHSEC/P18-815 (11)
Health conditions studied
1
Description of health condition studied
Knowledge, attitude, practice and self-efficacy for healthy meal preparation, food consumption pattern and body composition
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Knowledge, attitude, practice and self-efficacy for healthy meal preparation
Timepoint
2 weeks before intervention, 2 weeks after intervention and a 3-month follow-up
Method of measurement
Reliable and valid questionnaire
2
Description
Food consumption pattern
Timepoint
2 weeks before intervention, 2 weeks after intervention and a 3-month follow-up
Method of measurement
Reliable and validated questionnaire
3
Description
Home food availability
Timepoint
2 weeks before intervention, 2 weeks after intervention and a 3-month follow-up
Method of measurement
Reliable and valid questionnaire
4
Description
Body composition
Timepoint
2 weeks before intervention, 2 weeks after intervention and a 3-month follow-up
Method of measurement
BMI z-score: Tanita SC-330 for weight and stadiometer Seca 203 for height; waist circumference: measuring tape; body fat percent: Tanita SC-330
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Lifestyle
2
Description
Control group:
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Primary school selected
Full name of responsible person
Ng Choon Ming
Street address
1, Jalan Puncak Menara Gading, Taman Connaught, 56000 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
City
Kuala Lumpur
Postal code
56000
Phone
+60 3-9101 8880
Fax
Email
ngchoonming23@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
UCSI University
Full name of responsible person
Satvinder Kaur
Street address
1, Jalan Puncak Menara Gading, Taman Connaught, 56000 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
City
Kuala Lumpur
Postal code
56000
Phone
+60 3-9101 8880
Email
satvinderkaur@ucsiuniversity.edu.my
Grant name
Centre of Excellence for Research, Value Innovation and Entrepreneurship
Grant code / Reference number
Proj-In-FAS-058
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
UCSI University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
UCSI University
Full name of responsible person
Ng Choon Ming
Position
PhD Candidate
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
1, Jalan Puncak Menara Gading, Taman Connaught, 56000 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
City
Cheras, KL
Province
Kuala Lumpur
Postal code
56000
Phone
+60 10-362 7511
Email
ngchoonming23@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
UCSI University
Full name of responsible person
Satvinder Kaur
Position
Assistant Professor Dr.
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
1, Jalan Puncak Menara Gading, Taman Connaught, 56000 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
City
Kuala Lumpur
Province
Kuala Lumpur
Postal code
56000
Phone
+60 16-202 9941
Fax
Email
satvinderkaur@ucsiuniversity.edu.my
Person responsible for updating data
Contact
Name of organization / entity
UCSI University
Full name of responsible person
Ng Choon Ming
Position
Postgraduate student, PhD Candidate
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
29 Jln Bkt Beruang Utama 4, Tmn Bkt Beruang Utama, 75450 Melaka
City
Melaka
Province
Malaysia
Postal code
75450
Phone
+60 10-362 7511
Fax
Email
ngchoonming23@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available