UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial of web-based weight-loss program combined with human support for male worker under 40
Title of the study (Brief title)	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	Izumi Watai
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Nursing
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	Itsuko Ozaki
Organization	Nagoya City University
Division name	School of nursing
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://onlinelibrary.wiley.com/doi/10.1002/1348-9585.12037
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).
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