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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023809
Receipt No. 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

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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
Email 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/
Email itsuko@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya University,Graduate School of Medicine, Department of Nursing
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027367

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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