UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044469 |
|---|---|
| Receipt number | R000050799 |
| Scientific Title | Influence of remote nutrition education on meals and nutritional indicators in young women: randomized controlled trials |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2023/06/09 09:25:53 |
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Basic information
Public title
Influence of remote nutrition education using SNS on meals and nutritional indicators in young women
Acronym
Usefulness of remote nutrition education using SNS for young women
Scientific Title
Influence of remote nutrition education on meals and nutritional indicators in young women: randomized controlled trials
Scientific Title:Acronym
Usefulness of remote nutrition education for young women
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effects of remote nutrition education using digital technology on the eating habits, eating behavior, nutrition intake, muscle mass, and muscle strength of young women for improving their dietary habits.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the balance of nutrition intake (ratio of skipping breakfast, ratio of %protein intake / energy intake of breakfast, 24-hour urinary sodium/potassium ratio) after 3 and 12 months of intervention.
Key secondary outcomes
Changes in body composition, 24-hour urinary nitrogen excretion and pH, muscle strength, and eating behavior after 3 and/or 12 months of intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Intervention group receiving nutrition education
Interventions/Control_2
Control group not receiving nutrition education
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Participants are healthy female students with no physical, mental, or social difficulties who can give consent for the study.
Key exclusion criteria
1) Those who have diseases such as circulatory, metabolic, or renal diseases, and are receiving medication or treatment from medical doctors
2) Those who are pregnant or lactating.
3) Those who request to withdraw
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yasutake |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
yasutake@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yasutake |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
TEL
092-851-2531
Homepage URL
yasutake@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Nakamura Gakuen University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cooperation Promotion Department, Nakamura Gakuen University
Address
5-7-1 Befu Jonan-ku, Fukuoka, Japan
Tel
092-851-5579
kks@nakamura-u.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
| 2021 | Year | 07 | Month | 01 | 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
50
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
Terminated
Date of protocol fixation
| 2021 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 08 | Day |
Last modified on
| 2023 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050799
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
