UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046652 |
|---|---|
| Receipt number | R000044069 |
| Scientific Title | Trial of health behavior improvement by socio-ecological approach in diabetic patients -Recognition of walkability around residential area promotes steps- |
| Date of disclosure of the study information | 2022/01/16 |
| Last modified on | 2022/01/16 14:13:12 |
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Basic information
Public title
Attempt to promote health behaviors of diabetic patients using socio-ecological approach to establish exercise guidance considering individuality
Acronym
Trial of health behavior promotion by socio-ecological approach in patients with type 2 diabetes
Scientific Title
Trial of health behavior improvement by socio-ecological approach in diabetic patients -Recognition of walkability around residential area promotes steps-
Scientific Title:Acronym
An attempt to promote the number of steps in type 2 diabetic patients by providing guidance on walkability around residential area
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the motivational adjustment style in which physical activity is promoted by guidance of walking courses around residential areas as health education
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in steps before and after walkability around residential area
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A map of the hospital and the hospital grounds was used as the walking course guidance, and walking courses in the ward, the hospital, and hospital grounds were taught. The distance and estimated calorie consumption of each course were also indicated.
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 83 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Seventeen patients who were admitted to the hospital for diabetes education from September 2019 to November 2019 and whose physicians ordered physical therapists to provide exercise therapy were included in the study.
Key exclusion criteria
Subjects with serious complications, dementia, or lack of cooperation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Katsura |
| Middle name | |
| Last name | Mizoguchi |
Organization
Shuto General Hospital, JA Yamaguchi Prefectural Welfare Federation of Agricultural Cooperative
Division name
Department of Rehabilitation Medicine
Zip code
742-0032
Address
1000-1, Kogaisaku, Yanai City, Yamaguchi Pref, 742-0032, Japan
TEL
0820-22-3456
rh_k.mizoguchi@hsp-shuto.jp
Public contact
Name of contact person
| 1st name | Katsura |
| Middle name | |
| Last name | Mizoguchi |
Organization
Shuto General Hospital, JA Yamaguchi Prefectural Welfare Federation of Agricultural Cooperative
Division name
Department of Rehabilitation Medicine
Zip code
742-0032
Address
1000-1, Kogaisaku, Yanai City, Yamaguchi Pref, 742-0032, Japan
TEL
0820-22-3456
Homepage URL
rh_k.mizoguchi@hsp-shuto.jp
Sponsor or person
Institute
Shuto General Hospital, JA Yamaguchi Prefectural Welfare Federation of Agricultural Cooperative
Institute
Department
Personal name
Funding Source
Organization
Shuto General Hospital, JA Yamaguchi Prefectural Welfare Federation of Agricultural Cooperative
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
Shuto General Hospital, JA Yamaguchi Prefectural Welfare Federation of Agricultural Cooperative
Address
1000-1, Kogaisaku, Yanai City, Yamaguchi Pref, 742-0032, Japan
Tel
0820-22-3456
rh_k.mizoguchi@hsp-shuto.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 | 01 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
16
Results
A significant increase in physical activity was observed in the patients with the identified regulation style after instruction using the walking course guidance map.
Results date posted
| 2022 | Year | 01 | Month | 16 | Day |
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
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | 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
| 2022 | Year | 01 | Month | 16 | Day |
Last modified on
| 2022 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044069
| 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 |
