UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053636 |
|---|---|
| Receipt number | R000060780 |
| Scientific Title | Effectiveness of Nutrition Communication, Empowerment and Leadership Training of Trainers (NutriCEL ToT) for Nutrition Students in Empowering Undergraduates to Practise Healthy Nutrition: A Cluster Randomised Controlled Trial |
| Date of disclosure of the study information | 2024/02/16 |
| Last modified on | 2024/02/16 23:44:54 |
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Basic information
Public title
Effectiveness of Nutrition Communication, Empowerment and Leadership Training of Trainers (NutriCEL ToT) for Nutrition Students in Empowering Undergraduates to Practise Healthy Nutrition: A Cluster Randomised Controlled Trial
Acronym
Effectiveness of NutriCEL ToT for Nutrition Students in Empowering Undergraduates to Practise Healthy Nutrition: A Cluster Randomised Controlled Trial
Scientific Title
Effectiveness of Nutrition Communication, Empowerment and Leadership Training of Trainers (NutriCEL ToT) for Nutrition Students in Empowering Undergraduates to Practise Healthy Nutrition: A Cluster Randomised Controlled Trial
Scientific Title:Acronym
Effectiveness of NutriCEL ToT for Nutrition Students in Empowering Undergraduates to Practise Healthy Nutrition: A Cluster Randomised Controlled Trial
Region
| Asia(except Japan) |
Condition
Condition
Malnutrition, Overweight, Obesity
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate the effectiveness of Nutrition Communication, Empowerment and Leadership Training of Trainers (NutriCEL ToT) for nutrition students in empowering undergraduates to practise healthy nutrition.
Basic objectives2
Others
Basic objectives -Others
1. To develop a NutriCEL ToT module and educational materials for nutrition students
2. To determine socio-demographic background among nutrition students.
3. To determine the attendance rate and feedback of the NutriCEL ToT among intervention group participants.
4. To explore the perceptions, barriers, facilitators, and skills application of the NutriCEL ToT among the compliance and low/ non-compliance participants in the intervention group.
5. To determine the effectiveness of the ToT workshop for nutrition students in
a. body composition (body weight status, waist circumference, body fat percentage)
b. youth empowerment
c. healthy lifestyle knowledge
d. healthy eating and weight self-efficacy
e. diet quality
f. exercise self-efficacy
g. physical activity
h. intuitive eating behaviour
i. disordered eating behaviour
j. health promotion competencies
k. food security
l. health-related quality of life
between intervention and control groups before the ToT and after the ToT.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
a. Differences in body composition (body weight status, waist circumference, body fat percentage)
b. Differences in youth empowerment
c. Differences in healthy lifestyle knowledge
d. Differences in healthy eating and weight self-efficacy
e. Differences in diet quality
f. Differences in exercise self-efficacy
g. Differences in physical activity
h. Differences in intuitive eating behaviour
i. Differences in disordered eating behaviour
j. Differences in health promotion competencies
Key secondary outcomes
a. Differences in food security
b. Differences in health-related quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants in the intervention group attended a two-day Nutrition Communication, Empowerment and Leadership Training of Trainer and followed by an eight-week asynchronous nutrition empowerment activities.
Interventions/Control_2
Participants in the control group received a nutrition consultation.
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Malaysian nutrition students who are between 18 to 35 years old and in the second to final year of their study.
Key exclusion criteria
- Individuals who have chronic diseases
- Lactating, pregnant and post-partum women
- Individuals who have physical disability that affects body movement.
- Individuals who change food habits in the past six months for a specific purpose like muscle building, disease control and weight reduction.
Target sample size
118
Research contact person
Name of lead principal investigator
| 1st name | Yit Siew |
| Middle name | |
| Last name | Chin |
Organization
Faculty of Medicine and Health Sciences, Universiti Puta Malaysia
Division name
Department of Nutrition
Zip code
43400
Address
Fakulti Perubatan dan Sains Kesihatan, 43400 UPM Serdang, Selangor Darul Ehsan.
TEL
+603-89472680
chinys@upm.edu.my
Public contact
Name of contact person
| 1st name | Yit Siew |
| Middle name | |
| Last name | Chin |
Organization
Faculty of Medicine and Health Sciences, Universiti Puta Malaysia
Division name
Department of Nutrition
Zip code
43400
Address
Fakulti Perubatan dan Sains Kesihatan, 43400 UPM Serdang, Selangor Darul Ehsan.
TEL
+603-89472680
Homepage URL
chinys@upm.edu.my
Sponsor or person
Institute
Department of Nutrition, Faculty of Medicine and Health Sciences, Universiti Puta Malaysia
Institute
Department
Personal name
Associate Professor Dr. Chin Yit Siew
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
- Kennedy-Lugar Youth Exchange & Study (YES) Alumni Malaysia's community initiative fund
- Nutrition Division, Ministry of Health Malaysia
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 Serdang, Selangor,
Tel
+603-97691432
jkeupm@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 16 | 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
118
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2024 | Year | 06 | 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
| 2024 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060780
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| Registered date | File name |
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