UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047268 |
|---|---|
| Receipt number | R000053895 |
| Scientific Title | Survey on dietary choices aimed at raising health awareness: a parallel group-to-group comparative study |
| Date of disclosure of the study information | 2022/03/23 |
| Last modified on | 2022/05/16 23:33:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey on dietary choices aimed at raising health awareness: a parallel group-to-group comparative study
Acronym
Survey on dietary choices aimed at raising health awareness: a parallel group-to-group comparative study
Scientific Title
Survey on dietary choices aimed at raising health awareness: a parallel group-to-group comparative study
Scientific Title:Acronym
Survey on dietary choices aimed at raising health awareness: a parallel group-to-group comparative study
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to conduct an introduction test of the TLF label with the nutrition label affixed to the front of the food packaging and to verify its practicality when used for long periods in young people.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare dietary choices between the TLF-labeled and non-TLF-labeled groups for a week.
Key secondary outcomes
1) Compare the increase and decrease in the number of people who are conscious of a healthy diet in the TLF label use group and the non-use group.
2) Evaluate which of the nutritional components that should be noted for overdose will become conscious in the TLF label use group and the non-use group. (Calorie, fat, saturated fatty acid, sugar, salt, etc.)
3) Evaluate whether there is a difference in how stress is felt between the TLF label use group and the non-use group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention group: Select a meal once a day with the nutrition label (TLF label) when choosing a meal at dinner (for seven consecutive days)
Interventions/Control_2
Control group. Select a meal once a day at dinner without nutrition labeling (TLF labeling) (7 consecutive days)
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
Those who have received sufficient explanation about the purpose and contents of this research, have the ability to consent, volunteered voluntarily after fully understanding, and agreed to participate in writing.
Key exclusion criteria
Key exclusion criteria:
1) refuse to participate in the study;
2) Those who have dietary restrictions as a result of metabolic or endocrine disorders
3) People with eating disorders
4) Those who have anorexia
5) Those who have intentionally or unintentionally gained or lost weight by more than 5% in the past 3 months
6) are deemed ineligible by principal investigator for other reasons not listed above.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
n-wakui@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Wakui |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41 Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5760
Homepage URL
n-wakui@hoshi.ac.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Hoshi 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
Hoshi University Research Ethics Committee
Address
142-8501, 2-4-41 Ebara, Shinagawa-ku, Tokyo
Tel
03-3786-1011
somu@hoshi.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
| 2022 | Year | 03 | Month | 23 | 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
| 2022 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 16 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 16 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 16 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2022 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053895
