UMIN-CTR Clinical Trial

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
Email	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
Email	j.nohara@kio.ac.jp

Sponsor
Institute	Department of Health Nutrition, School of Health Science, Kio University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043591