UMIN-CTR Clinical Trial

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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