UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033152 |
|---|---|
| Receipt number | R000036739 |
| Scientific Title | Effects of agricultural and horticultural activity |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2020/08/06 10:30:27 |
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Basic information
Public title
Effects of agricultural and horticultural activity
Acronym
Effects of agricultural and horticultural activity
Scientific Title
Effects of agricultural and horticultural activity
Scientific Title:Acronym
Effects of agricultural and horticultural activity
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether agricultural and horticultural activity improves eating behavior in patients with diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eating behavior
Key secondary outcomes
HbA1c, body composition, physical activity, psychological condition
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
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
Agricultural and horticultural activity for 4 months
Interventions/Control_2
Conventional diet therapy and exercise
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with diabetes attending Kyoto University Hospital who can engage in agricultural and horticultural activity
Key exclusion criteria
Those who cannot responce self-administered questionnaires
Those who cannot express their intention during the process of informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ikeda |
Organization
Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL
075-751-3560
krikeda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Ikeda |
Organization
Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
6068507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL
075-751-3560
Homepage URL
krikeda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Konoecho, Yoshida, Sakyo-ku Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2018 | 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
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
| 2018 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 15 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 26 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036739
