UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053411 |
|---|---|
| Receipt number | R000060954 |
| Scientific Title | Verification of the effects of educational methods and nudges on the promotion of amino acid intake and physical activity |
| Date of disclosure of the study information | 2024/01/22 |
| Last modified on | 2024/01/24 09:21:26 |
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Basic information
Public title
Verification of the effects of educational methods and nudges on the promotion of amino acid intake and physical activity
Acronym
Verification of the effects of educational methods and nudges on the promotion of amino acid intake and physical activity
Scientific Title
Verification of the effects of educational methods and nudges on the promotion of amino acid intake and physical activity
Scientific Title:Acronym
Verification of the effects of educational methods and nudges on the promotion of amino acid intake and physical activity
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and verify whether educational methods and nudges have behavioral change effects on amino acid intake and physical activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical activity
Amount of amino acid supplements used
Key secondary outcomes
Body weight, Body composition,
Intention to improve physical activity, Physical activity intensity
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
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In the on-site survey, answer a questionnaire.
Interventions/Control_2
Educational methods group
Interventions/Control_3
Educational methods and nudges group
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Men and women between the ages of 20 and 69.
2)Exercise less than once a week, but are willing to improve their physical activity habits and walking time.
3)People who know about amino acid foods but do not purchase or continue using them.
4)Those who agree to wear an activity monitor during the test period.
5)Those who participate in the venue survey and follow-up survey during the exam period and are able to return the activity monitor.
6)Those who do not work in the manufacturing industry (beverage/food), wholesale industry, retail industry, mass media industry, advertising industry, media industry, research industry, consulting industry, medical care, or pharmaceutical industry.
7)Those who fully understand the research participation and have given their own voluntary written consent.
Key exclusion criteria
(1)Those who are pregnant or may become pregnant
(2)People with high blood pressure or heart disease
(3)Those with fractures or joint damage
(4)Those who have a weak sense of balance or feel dizzy
(5)Severely obese
(6)People with diabetes
(7)Those who currently have some kind of food allergy
(8)Persons other than those listed above who are deemed unsuitable as subjects for this study by the research director/responsible physician.
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Okabe |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
070-4017-9653
yuki.okabe.z4s@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Kanna |
| Middle name | |
| Last name | Kuribayashi |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
070-4017-9560
Homepage URL
kanna.kuribayashi.jv3@asv.ajinomoto.com
Sponsor or person
Institute
Cross Marketing Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
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
AJINOMOTO CO., INC. Committee for the Examination of Trials Involving Humans
Address
15-1, Kyobashi 1-chome, Chuo-ku, Tokyo, Japan
Tel
03-5250-8111
ajinomoto_irb@ajinomoto.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
| 2024 | Year | 01 | Month | 22 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2024 | Year | 01 | Month | 22 | Day |
Last modified on
| 2024 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060954
| Research Plan | |
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| 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 |
