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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039773
Receipt No. 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 2020/03/11

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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.Obtained parents' consent
3.All body weight status
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 334

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
Email 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
Email chinys@upm.edu.my

Sponsor
Institute Department of Nutrition and Dietetics, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia
Institute
Department

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
Email 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
2020 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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