UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023809 |
|---|---|
| Receipt number | R000027367 |
| Scientific Title | A randomized controlled trial of web-based weight-loss program combined with human support for male worker under 40 |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2019/02/26 18:06:00 |
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Basic information
Public title
A randomized controlled trial of web-based weight-loss program combined with human support for male worker under 40
Acronym
A randomized controlled trial of web-based weight-loss program combined with human support for male worker under 40
Scientific Title
A randomized controlled trial of web-based weight-loss program combined with human support for male worker under 40
Scientific Title:Acronym
A randomized controlled trial of web-based weight-loss program combined with human support for male worker under 40
Region
| Japan |
Condition
Condition
Obesity, overweight
Classification by specialty
| Endocrinology and Metabolism | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to compare the effectiveness of a web-based weight-loss program combined with human support and a web-based weight-loss program.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Weight loss[12-week,24-week,48-week]
Key secondary outcomes
Body mass index
Waist circumference
Percent of body fat
Frequency of self-monitoring
Energy expenditure
Energy intake
Self-efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The participants of Enhanced Support Group(ESG)are provided group guidance regarding the weight loss strategy at the beginning and the end of 12-week program. And they are encouraged to log on the website and use self-monitoring tool. They are provided small-group session at the each group guidance to promote adherence to use the website. Additionally, participants receive one telephone support and online advice a total of 3 times during the program.
Interventions/Control_2
The participants of Standard Support Group(SSG) are provided group guidance regarding the weight loss strategy at the beginning and the end of 12-week program. And they are encouraged to log on the website and use self-monitoring tool.
Interventions/Control_3
The participants of delayed Control Group(CG) are not given specific instruction. They are provided the same program as control group after the 12-week program.
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Body mass index >= 25
Subjects with life-style disease and orthopedic disorder obtained permission from the primary doctor
subjects who can always access internet
Key exclusion criteria
Subjects who had surgery within 6 months
Subjects who have orthopedic disease
Subjects who have severe psychiatric problem
Subjects who participate other programs during this intervention
Subjects who succeeded in losing weight greater than or equal 5% in the past year
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Izumi Watai |
Organization
Nagoya University
Graduate School of Medicine
Division name
Department of Nursing
Zip code
Address
1-1-20 Daiko-minami,Higashi-ku,Nagoya,Aichi461-8673 JAPAN
TEL
+81-52-719-3151
izumiw@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Itsuko Ozaki |
Organization
Nagoya City University
Division name
School of nursing
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi467-8601 JAPAN
TEL
+81-52-853-8845
Homepage URL
http://seikatsu-kaizen-ncu.jp/
itsuko@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya University,Graduate School of Medicine, Department of Nursing
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ehime University,Graduate School of Medicine, Department of Nursing
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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/1348-9585.12037
Number of participants that the trial has enrolled
Results
ESG participants reduced their weight significantly more than SSG and CG participants (p=0.038, p<0.001), and SSG participants reduced their weight significantly more than CG participants (p=0.033).
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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 29 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027367
| Research Plan | |
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| Registered date | File name |
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