UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002858 |
|---|---|
| Receipt number | 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 16:32:27 |
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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
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
Sponsor or person
Institute
Nara Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003487
