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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025340
Receipt No. R000028245
Scientific Title Effect of the FiNC-style weight-loss program on weight loss in Japanese adults
Date of disclosure of the study information 2016/12/22
Last modified on 2019/01/08

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Basic information
Public title Effect of the FiNC-style weight-loss program on weight loss in Japanese adults
Acronym Effect of the FiNC-style weight-loss program on weight loss in Japanese adults
Scientific Title Effect of the FiNC-style weight-loss program on weight loss in Japanese adults
Scientific Title:Acronym Effect of the FiNC-style weight-loss program on weight loss in Japanese adults
Region
Japan

Condition
Condition obesity
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to examine the effect of the FiNC-style weight-loss program on weight loss
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Body weight
Key secondary outcomes Body composition
Waist circumference
Systolic blood pressure
Diastolic blood pressure
Triglycerides
High-density lipoprotein cholesterol
Fasting plasma glucose
Hemoglobin A1c
Mental health

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 A 8 weeks group-based weight-loss support program via Internet chat-room
Interventions/Control_2 No treatment
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
65 years-old >
Gender Male and Female
Key inclusion criteria A body mass index is 25 or more and waist circumference 85cm or more in males and 90cm or more in females, and the presence of at least one of the following conditions.
1. Fasting plasma glucose level 100mg/dL or more. Or HbA1c 5.2% or more.
2. Triglycerides level 150mg/dL or more. Or high-density lipoprotein cholesterol level less than 40mg/dL
3. Systolic blood pressure 130mmHg or more. Or diastolic blood pressure 85mmHg or more.
Key exclusion criteria 1. Participation in a weight-loss program.
2. Contraindication of weight loss for dietary modification at a physician's direction.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoji Tanaka
Organization University of Tsukuba
Division name Fucalty of health and sports science
Zip code
Address 1-1-1 Tennodai, Tsukuba
TEL 029-853-2655
Email tanaka@taiiku.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyoji Tanaka
Organization Universty of Tsukuba
Division name Fucalty of health and sports science
Zip code
Address 1-1-1 Tennodai, Tsukuba
TEL 029-853-2655
Homepage URL
Email tanaka@taiiku.tsukuba.ac.jp

Sponsor
Institute Universty of Tsukuba
Institute
Department

Funding Source
Organization FiNC
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.dovepress.com/professional-dietary-coaching-within-a-group-chat-using-a-smartphone-a-pee
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 Completed
Date of protocol fixation
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 20 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028245

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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