UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025340 |
|---|---|
| Receipt number | 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 12:14:13 |
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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
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
tanaka@taiiku.tsukuba.ac.jp
Sponsor or person
Institute
Universty of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028245
