UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049783 |
|---|---|
| Receipt number | R000056653 |
| Scientific Title | A Randomized Parallel Group Trial to Evaluate the Impact of a Work Program Involving Snacks on Psychological Well-Being |
| Date of disclosure of the study information | 2022/12/20 |
| Last modified on | 2023/12/15 09:04:16 |
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Basic information
Public title
A Randomized Parallel Group Trial to Evaluate the Impact of a Work Program Involving Snacks on Psychological Well-Being
Acronym
A Randomized Parallel Group Trial to Evaluate the Impact of a Work Program Involving Snacks on Psychological Well-Being
Scientific Title
A Randomized Parallel Group Trial to Evaluate the Impact of a Work Program Involving Snacks on Psychological Well-Being
Scientific Title:Acronym
A Randomized Parallel Group Trial to Evaluate the Impact of a Work Program Involving Snacks on Psychological Well-Being
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine changes in the psychological wellbeing of the subjects before and after the work program by implementing a program consisting of work composed of involvement in snacks that is a natural part of daily life. In addition, changes in subjective wellbeing and purpose in life will also be examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total Flourishing Scale (FS), one measure of psychological wellbeing.
Pre-intervention, immediate post-intervention, and persistence (after 2 weeks and 1 month)
Key secondary outcomes
Subjective wellbeing (Scale of Positive and Negative Experience, Satisfaction With Life Scale)
Total score of Ikigai-9
Pre-intervention, immediate post-intervention, and persistence (after 2 weeks and 1 month)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Provide a program consisting of "sharing with others," "giving to others," and "background" involvement in snacks.
The work program will be implemented sequentially for the intervention group, and questionnaires will be administered before the work program, immediately after the work program, and two weeks and one month after the work program.
Interventions/Control_2
Eat the snacks without experiencing the program involved in the snacks.
Surveys will be administered before, after and 2 weeks and 1 month after the tasting.
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Approximately 300 registered members of Morinaga Seika's online community "Angel PLUS" aged 20-79
2) Persons who can obtain consent by electromagnetic means after confirming the instructions to the research subjects by electromagnetic means
3) Those who have access to the Internet environment (video viewing, Internet search, and questionnaire responses are available).
Key exclusion criteria
1)Those who suffer from some kind of mental illness and are undergoing treatment.
2) Those who are allergic to eggs, milk, wheat, peanuts, or soybeans
3) Persons whose fasting blood glucose level is in the diabetic range (fasting blood glucose of 126 mg/dL or higher)
4) Persons who may change their lifestyle during the study period (night work, long trips, childbirth, marriage, etc.)
5) Persons who are recognized by the study sponsor as being incapable of cooperating in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Kawamoto |
Organization
Morinaga Seika Co.
Division name
research institute
Zip code
230-8504
Address
2-1-1 Shimosueyoshi, Tsurumi-ku, Yokohama City
TEL
045-571-6140
m-kawamoto-hf@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Miku |
| Middle name | |
| Last name | Suzuki |
Organization
Morinaga Seika Co.
Division name
research institute
Zip code
230-8504
Address
2-1-1 Shimosueyoshi, Tsurumi-ku, Yokohama City
TEL
070-3864-8580
Homepage URL
m-suzuki-ji@morinaga.co.jp
Sponsor or person
Institute
Morinaga Seika Co.
research institute
Institute
Department
Personal name
Funding Source
Organization
Morinaga Seika Co.
research institute
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nonprofit Organization MINS
Address
ST Shibuya Bldg. 2F, 1-15-14 Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 12 | Month | 20 | 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
312
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 | 12 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 14 | Day |
Last modified on
| 2023 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056653
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| Registered date | File name |
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