UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005869 |
|---|---|
| Receipt number | R000006936 |
| Scientific Title | A Randomized Controlled Trial to Assess the Effectiveness of Peer-assisted Learning on Body Weight Reduction in Health Guidance |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2018/03/26 11:29:21 |
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Basic information
Public title
A Randomized Controlled Trial to Assess the Effectiveness of Peer-assisted Learning on Body Weight Reduction in Health Guidance
Acronym
Effectiness of Peer-assisted Learning on Body Weight Reduction in Health Guidance
Scientific Title
A Randomized Controlled Trial to Assess the Effectiveness of Peer-assisted Learning on Body Weight Reduction in Health Guidance
Scientific Title:Acronym
Effectiness of Peer-assisted Learning on Body Weight Reduction in Health Guidance
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of "Peer-Assisted Learning" among the counselors in health guidance on the clients' weight reduction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
change in the clients' body weight
Key secondary outcomes
1.OSCE evaluation in the counselors
2.BMI change in the clients
3.change in the clients' abdominal circumference
4.change in the food habit of clients
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
"Peer-assisted Learning" among counselors in addition to training in advance by the counselor educator
Interventions/Control_2
training in advance by the counselor educator alone
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.abdominal circumference >= 85cm in men or >= 90cm in women, or BMI>= 25 in both sex
2.equal to or more than 18 years old, and equal to or less than 65 years old
3.availability of web services in home or the workplace
4.written informed consent
Key exclusion criteria
patients receiving prescribed medication for diabetes or kidney disease
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Kawamura |
Organization
Kyoto university School of Public Health
Division name
Department of Preventive services
Zip code
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2426
kawax@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mie Imanaka |
Organization
Health Service
Division name
Department of Preventive services
Zip code
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
090-7485-7611
Homepage URL
m-imanaka@mail.koka.ac.jp
Sponsor or person
Institute
Department of Preventive Services,
Kyoto university School of Public health
Institute
Department
Personal name
Funding Source
Organization
Department of Preventive Services,
Kyoto university School of Public health
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 07 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006936
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
