UMIN-CTR Clinical Trial

Basic information
Public title	A lifestyle-related disease prevention classroom at a Drug Addiction Recovery Center
Acronym	A lifestyle-related disease prevention classroom at a Drug Addiction Recovery Center
Scientific Title	A lifestyle-related disease prevention classroom at a Drug Addiction Recovery Center
Scientific Title:Acronym	A lifestyle-related disease prevention classroom at a Drug Addiction Recovery Center
Region	Japan

Condition
Condition	Substance use disorders
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To implement a lifestyle-related disease preventative intervention at Drug Rehabilitation Center and to examine its effect.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the effect of the intervention with The Diagnostic Inventory of Health and Life Habit (DIHAL.2) pre- and post- intevenion.
Key secondary outcomes	Physcal measurement including Body mass Index(BMI) and waist circumference

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	The intervention is a group-guided program that composed of four sessions; once every four weeks. Each session consisted of two parts. In the first half, a 60-minute health lecture/exercise was conducted, and in the second half, a 40-minute stretch, resistance exercise, and aerobics were conducted for a total of 100 minutes. Each lecture/exercise focused on the three elements that are the basic elements of lifestyle-related disease prevention: nutrition and diet, physical activity and exercise, and rest and sleep.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who partcipates in the day care program at Hachioji Drug Addiction Rehabilitation Center(DARC)
Key exclusion criteria	1) Those who cannot understand the contents of the program or who have difficulty in conversation 2) Those who cannot participant in physical activity due to a doctor's instruction to prohibit exercise, diseases or pains in the knee joint, etc. 3) Those who are considered inappropriate by the representative of Hachioji DARC as the subject of this study in consideration of physical and mental conditions.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Takuya Middle name Last name Shimane
Organization	National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name	Department of Drug Dependence Research
Zip code	1878553
Address	4-1-1 Ogawa-higashi, Kodaira, Tokyo
TEL	042-341-2712
Email	shimane@ncnp.go.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Inoura
Organization	National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name	Department of Drug Dependence Research
Zip code	1878553
Address	4-1-1 Ogawa-higashi, Kodaira, Tokyo
TEL	042-341-2712
Homepage URL
Email	inoura@ncnp.go.jp

Sponsor
Institute	Department of Drug Dependence Research, National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	No applicable
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	National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa-higashi, Kodaira, Tokyo
Tel	042-341-2712
Email	rinri-jimu@ncnp.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	2020 Year 06 Month 30 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	14
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	2019 Year 07 Month 16 Day
Date of IRB	2019 Year 07 Month 24 Day
Anticipated trial start date	2019 Year 09 Month 13 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry	2020 Year 07 Month 31 Day
Date trial data considered complete	2020 Year 08 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 06 Month 29 Day
Last modified on	2020 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046748