UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038237 |
|---|---|
| Receipt number | R000043591 |
| Scientific Title | Effect of Improvement of nutritional calculation skill by being involved in smart meals:non-randomize control trial |
| Date of disclosure of the study information | 2019/10/08 |
| Last modified on | 2021/11/01 12:12:21 |
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Basic information
Public title
Effect of Improvement of nutritional calculation skill by being involved in smart meals:non-randomize control trial
Acronym
Effect of Improvement of nutritional calculation skill by being involved in smart meals:non-randomize control trial
Scientific Title
Effect of Improvement of nutritional calculation skill by being involved in smart meals:non-randomize control trial
Scientific Title:Acronym
Effect of Improvement of nutritional calculation skill by being involved in smart meals:non-randomize control trial
Region
| Japan |
Condition
Condition
Collage students majoring in nutrition
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of Improved nutritional calculation skills by Smart meal authentication involvement
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
degree of the change of nutritional calculation skills by questionnaires
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Training of nutrition calculation
Nutrition calculation of Smart meal certification
Interventions/Control_2
Training of nutrition calculation
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
College students majoring in nutrition
Key exclusion criteria
nothing special
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Nohara |
Organization
Kio University
Division name
Department of Health Nutrition
Zip code
6350832
Address
4-2-2 Umaminaka, Koryo-cho, Kitatsukagi-gun, Nara Prefecture
TEL
0745-54-1601
j.nohara@kio.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Nohara |
Organization
Kio University
Division name
Department of Health Nutrition
Zip code
6350832
Address
4-2-2 Umaminaka, Koryo-cho, Kitatsukagi-gun, Nara Prefecture
TEL
0745-54-1601
Homepage URL
j.nohara@kio.ac.jp
Sponsor or person
Institute
Department of Health Nutrition,
School of Health Science, Kio University
Institute
Department
Personal name
Funding Source
Organization
Department of Health Nutrition,
School of Health Science, Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Shizuoka
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka, Koryo-cho, Kitatsukagi-gun, Nara Prefecture
Tel
0745-54-1601
j.nohara@kio.ac.jp
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
| 2019 | Year | 10 | Month | 08 | Day |
Related information
URL releasing protocol
https://kio.repo.nii.ac.jp/?action=repository_uri&item_id=67&file_id=22&file_no=1
Publication of results
Published
Result
URL related to results and publications
https://kio.repo.nii.ac.jp/?action=repository_uri&item_id=67&file_id=22&file_no=1
Number of participants that the trial has enrolled
159
Results
Dietary intakes between COVID-19 pandemic and non-pandemic were significantly different for 4 nutritions. Energy ,carbohydrate(% energy) were decreased, and calcium, tocopherol were increased.
Results date posted
| 2021 | Year | 11 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 30 | Day |
Baseline Characteristics
159 undergraduate
Japanese female dietetic students
Participant flow
For those who have obtained consent from 3rd and 4th year female university students who belong to the Department of Health and Nutrition of kio university
Adverse events
non
Outcome measures
Anthropometric values, dietary intake, questionnaire items
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 30 | Day |
Other
Other related information
Since the planned intervention was not possible, I wrote "Eating habits change during COVID-19 pandemic among undergraduate Japanese female dietetic students on 1-day weighed dietary record." using the data obtained in this study."
Management information
Registered date
| 2019 | Year | 10 | Month | 08 | Day |
Last modified on
| 2021 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043591
