UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040947 |
|---|---|
| Receipt number | 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 15:54:15 |
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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
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
inoura@ncnp.go.jp
Sponsor or person
Institute
Department of Drug Dependence Research, National Institute of Mental Health, National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046748
