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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040947
Receipt No. R000046748
Scientific Title A lifestyle-related disease prevention classroom at a Drug Addiction Recovery Center
Date of disclosure of the study information 2020/06/30
Last modified on 2020/06/30

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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

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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