UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043055 |
|---|---|
| Receipt number | R000049152 |
| Scientific Title | Chrono-nutritional intervention using a food-log based health App |
| Date of disclosure of the study information | 2021/01/24 |
| Last modified on | 2022/02/24 14:50:03 |
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Basic information
Public title
Chrono-nutritional intervention using a food-log based health App
Acronym
Chrono-nutritional intervention using a food-log based health App
Scientific Title
Chrono-nutritional intervention using a food-log based health App
Scientific Title:Acronym
Chrono-nutritional intervention using a food-log based health App
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the effect of the chrono-nutritional intervention on the bodyweight change in the App users.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Food log, sleep parameters, physical activity, personality, depression score, health score, bodyweight, BMI, body fat percentage, step counts
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
For the intervention, users of this App are asked those 4 contents during the next 1 month.
1. reduce the duration of food intake to less than 12 hours. 2. reduce carbohydrates intake at dinner. 3. balance the food amount in each breakfast, lunch, and dinner for 3:3:3. 4. try to record food log at leat 3 days per a week. Users are asked to answer the surveys before and after the intervention.
Interventions/Control_2
For the control group, we ask surveys twice and ask to use this App for a month.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We divided two groups randomly at first, then the half of users are asked to join the intervention group, and another half are asked to join the control group.
Key exclusion criteria
Subjects who drop out to use this App or record logs for less than 3 days/week.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Shigenobu |
| Middle name | |
| Last name | Shibata |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
1620056
Address
Wakamatsu-cho 2-2, Shinjuku-ku, Tokyo
TEL
03-5369-7318
shibatas@waseda.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Waseda University
Division name
Faculty of Science and Engineering
Zip code
1620056
Address
Wakamatsu-cho 2-2, Shinjuku-ku, Tokyo
TEL
03-5369-7318
Homepage URL
yutahara0829@gmail.com
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
Tozuka-cho 1-104, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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 | 01 | Month | 24 | 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
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
| 2021 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 05 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 19 | Day |
Last modified on
| 2022 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049152
| 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 |
