UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Acceptance and Commitment Therapy on glycemic control in type 2 diabetes patients
Acronym	ACTION
Scientific Title	Evaluation of Acceptance and Commitment Therapy on glycemic control in type 2 diabetes patients
Scientific Title:Acronym	ACTION
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the effect of acceptance and commitment therapy on HbA1c change in type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c after 6 months
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Receive medical treatment guidance by Acceptance and Commitment Therapy within 3 months of obtaining consent. Receive nutritional guidance at 0, 3, 6, and 9 months.
Interventions/Control_2	Receive nutritional guidance at 0, 3, 6, and 9 months.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Patient with type 2 diabetes Patient whose HbA1c level is 6-9% Patients who have given their written consent
Key exclusion criteria	Patient who can not speak Japanese Patient with cognitive disorder Patient who have been admitted to the hospital with diabetes within 3 months prior to the date of consent Patient who were changed in glucose-lowering drugs within 3 months prior to the date of consent Patient who participated in other interventional studies
Target sample size	106

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Makino
Organization	National Cerebral and Cardiovascular Center
Division name	Diabetes and Lipid metabolism
Zip code	564-8565
Address	6-1, KIshibeshinmachi, Osaka, Japan
TEL	+81661701070
Email	makinoh@ncvc.go.jp

Public contact
Name of contact person	1st name Hisashi Middle name Last name Makino
Organization	National Cerebral and Cardiovascular Center
Division name	Diabetes and Lipid metabolism
Zip code	564-8565
Address	6-1, KIshibeshinmachi, Osaka, Japan
TEL	+81661701070
Homepage URL
Email	makinoh@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	Japanese Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Review Committee of National Cerebral and Cardiovascular Center
Address	6-1, KIshibeshinmachi, Osaka, Japan
Tel	+81661701070
Email	rec-office-ac@ncvc.go.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	2021 Year 11 Month 05 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	Open public recruiting
Date of protocol fixation	2021 Year 03 Month 10 Day
Date of IRB	2021 Year 04 Month 08 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2023 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 05 Day
Last modified on	2021 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052241