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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046652
Receipt No. 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

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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
Email 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
Email rh_k.mizoguchi@hsp-shuto.jp

Sponsor
Institute Shuto General Hospital, JA Yamaguchi Prefectural Welfare Federation of Agricultural Cooperative
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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