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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028214
Receipt No. 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 2018/08/20

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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
Middle name
Last name Kiyoji Tanaka
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-2655
Email tanaka.kiyoji.ft@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoko Mizushima
Organization University of Tsukuba Graduate School of Comprehensive Human Sciences
Division name Doctoral Program in Sports Medicine
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-8366
Homepage URL
Email s1630387@u.tsukuba.ac.jp

Sponsor
Institute Faculty of Health and Sport Sciences, University of Tsukuba
Institute
Department

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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 16 Day
Date of IRB
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
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032277

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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