UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039773 |
|---|---|
| Receipt number | R000045358 |
| Scientific Title | Evaluation of a community-based football-driven nutrition education program among primary school children |
| Date of disclosure of the study information | 2020/03/11 |
| Last modified on | 2022/07/10 01:21:36 |
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Basic information
Public title
Evaluation of a community-based football-driven nutrition education program among primary school children
Acronym
Community-based football-driven nutrition education program among primary school children
Scientific Title
Evaluation of a community-based football-driven nutrition education program among primary school children
Scientific Title:Acronym
Community-based football-driven nutrition education program among primary school children
Region
| Asia(except Japan) |
Condition
Condition
Malnutrition, overweight, obesity, stunted and underweight
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a community-based football-driven nutrition education program among primary school children
Basic objectives2
Others
Basic objectives -Others
1.To determine the socio-demographic background of the primary school children at baseline.
2.To evaluate the implementation process of the intervention program (attendance and feedback of the program)
3.To determine and compare the main differences in:
(i) Nutrition knowledge, attitude, and practice (KAP),
(ii) Physical activity (physical activity level, aerobic endurance, muscle endurance, lower limb muscle strength, flexibility),
(iii) Dietary practices (eating behaviours, meal consumption, meal skipping, snack, family meals and food-away-from-home, food companion, nutrient intake),
(iv) Body compositions (BMI-for-age, height-for-age, body weight status, body fat percentage, skeletal muscle mass, waist circumference),
(v) Cognitive performance, and
(vi) Health-related quality of life (HRQoL)
between intervention and control groups, before intervention (baseline), after intervention (post-intervention I), and at 3-month follow up (post-intervention II).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Changes in nutrition knowledge, attitude and practice (included physical activity level and dietary practices)
Key secondary outcomes
(1) Changes in physical fitness
(2) Changes in body compositions
(3) Changes in cognitive performance
(4) Changes in health-related quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The children in the intervention group in the intervention group will be participating in the intervention program which will be educating nutrition and football technique (30 topics) for 1 year period.
Interventions/Control_2
Children in the control group are not subjected to any intervention until the end of the study period.
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
| 7 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male and Female
2. From low-income (B40) family
Key exclusion criteria
1.Non-Malaysian
2.Any diagnosed physical disability which affect the execution of activities such as limb defects, spinal cord injury or other condition listed by the Department of Social Welfare
3.Any diagnosed mental disability which affect the his or her relationship with the community such as organic mental disorder, depression or other condition listed by Department of Social Welfare
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Yit Siew |
| Middle name | |
| Last name | Chin |
Organization
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Puta Malaysia
Division name
Department of Nutrition and Dietetics
Zip code
43400
Address
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia.
TEL
+603-89472680
chinys@upm.edu.my
Public contact
Name of contact person
| 1st name | Yit Siew |
| Middle name | |
| Last name | Chin |
Organization
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, UPM
Division name
Department of Nutrition and Dietetics
Zip code
43400
Address
Faculty of Medicine and Health Sciences, UPM, 43400 Serdang, Selangor, Malaysia
TEL
+603-89472680
Homepage URL
chinys@upm.edu.my
Sponsor or person
Institute
Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
Institute
Department
Personal name
Funding Source
Organization
WVM Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Research Involving Human Subjects Universiti Putra Malaysia
Address
Office of the Deputy Vice Chancellor (Research & Innovation), Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia
Tel
+603-97691002
tncpi@upm.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
Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 11 | 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
564
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
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045358
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| Registered date | File name |
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