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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002858
Receipt No. R000003487
Scientific Title Efficacy of obesity improvement program for metabolic syndrome reserve
Date of disclosure of the study information 2009/12/07
Last modified on 2018/04/06

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Basic information
Public title Efficacy of obesity improvement program for metabolic syndrome reserve
Acronym Web-based weight-loss program : Project Health
Scientific Title Efficacy of obesity improvement program for metabolic syndrome reserve
Scientific Title:Acronym Web-based weight-loss program : Project Health
Region
Japan

Condition
Condition Obesity
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 we conducted a randomized controlled trial (RCT) to examine the efficacy of a one-year web-based weight-loss program for male employees.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Body weight and weight circumference.
Key secondary outcomes Body mass index, Blood pressure, clinical characteristics, physical activity, dietary intake

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 decrease dietary intake
Interventions/Control_2 Increase physical activity
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
30 years-old <=
Age-upper limit
49 years-old >=
Gender Male
Key inclusion criteria 30 to 49 years old for men, A body mass index (BMI) of 25 to 30 kg/m2 based on results from the yearly company health check-up conducted between April and June 2007.
Key exclusion criteria Subjects who were diagnosed with or receiving treatment for myocardial infarction, other heart diseases, stroke, diabetes, hypertension, and hyperlipidemia were excluded.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chigusa Date
Organization Nara Women's University
Division name Faculty of Human Life and Environment
Zip code
Address Kitauoyanishi-machi, Nara, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chigusa Date
Organization Nara Women's University
Division name Faculty of Human Life and Environment
Zip code
Address Kitauoyanishi-machi, Nara, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Nara Women's University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2009 Year 12 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Terminated
Date of protocol fixation
2007 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 12 Month 07 Day
Last modified on
2018 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003487

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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