UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028214 |
|---|---|
| Receipt number | R000032277 |
| Scientific Title | A comparison of expert-led and volunteer-led weight-loss programs |
| Date of disclosure of the study information | 2017/07/14 |
| Last modified on | 2023/11/21 13:18:20 |
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Basic information
Public title
A comparison of expert-led and volunteer-led weight-loss programs
Acronym
A comparison of expert-led and volunteer-led weight-loss programs
Scientific Title
A comparison of expert-led and volunteer-led weight-loss programs
Scientific Title:Acronym
A comparison of expert-led and volunteer-led weight-loss programs
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare expert-led and volunteer-led weight-loss programs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Body weight
Key secondary outcomes
Waist circumference
Systolic blood pressure
Diastolic blood pressure
Triglycerides
High-density lipoprotein cholesterol
Fasting plasma glucose
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
expert-led weight-loss program
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A body mass index is 25 or more but less than 40
Key exclusion criteria
Past history of coronary disease
Past history of stroke
Current or planned pregnancy
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kiyoji |
| Middle name | |
| Last name | Tanaka |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
3050006
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-2655
tanaka.kiyoji.ft@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Mizushima |
Organization
University of Tsukuba Graduate School of Comprehensive Human Sciences
Division name
Doctoral Program in Sports Medicine
Zip code
3050006
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-8366
Homepage URL
ryoko.mizushima@outlook.jp
Sponsor or person
Institute
Faculty of Health and Sport Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba Educational Research Funding
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
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
029-853-2571
hitorinri@un.tsukuba.ac.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
筑波大学 / University of Tsukuba
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 14 | 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
Main results already published
Date of protocol fixation
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032277
