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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040195
Receipt No. R000045836
Scientific Title Effects of educational tool on health behavior for weight reduction in middle aged workers with high body mass index and coronary risk factors: a pilot randomized controlled trial
Date of disclosure of the study information 2020/04/19
Last modified on 2021/03/04

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Basic information
Public title Development of educational tool to promote decision making for weight reduction in adults with body mass index >= 24 kg/m2
Acronym Development of educational tool to promote decision making for weight reduction
Scientific Title Effects of educational tool on health behavior for weight reduction in middle aged workers with high body mass index and coronary risk factors: a pilot randomized controlled trial
Scientific Title:Acronym Effects of educational tool on health behavior for weight reduction in middle aged workers
Region
Japan

Condition
Condition diabetes mellitus, dyslipidemia and hypertension
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of evidence-based individualized educational tool considering the subject's consciousness of disease and values on health behavior in middle aged workers with high body mass index and coronary risk factors.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Will of weight monitoring
-Will of dietary restriction for weight reduction
-Will of exercise for weight reduction
-Evaluation period: Before and after providing educational tool
Key secondary outcomes -Physical activity
-Weight monitoring frequency
-Dietary proclivity
-Interest level for lifestyle modification(will of weight monitoring,will of dietary restriction for weight reduction, will of exercise for weight reduction)
-Evaluation period: Before and at 1-month after providing educational tool

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Definition
Intervention: A group that receives individualized educational tool for weight reduction

Note
They receive educational tool to promote lifestyle modification for weight reduction individualized according to their coronary risk factors and questionnaire responses.
Interventions/Control_2 Definition
Control: A group that receives standard educational tool for weight reduction

Note
Control: They receive standard educational tool to promote lifestyle modification for weight reduction.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Middle aged workers with body mass index >= 24 kg/m2
-Under treatment of diabetes mellitus, hypertension, dyslipidemia, or with one or more of the following: systolic blood pressure>=140mmHg; diastolic blood pressure>=90mmHg; triglyceride>=150mg/dL; low density lipoprotein cholesterol>=140mg/dL; high density lipoprotein cholesterol<40mg/dL; fasting plasma glucose>=126mg/dL; hemoglobin A1c>=6.5%
-People who provide written informed consent
Key exclusion criteria Not applicable
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Sumio
Middle name
Last name Yamada
Organization Nagoya University
Division name Graduate School of Medicine (Health Sciences)
Zip code 461-8673
Address 1-1-20 Daiko-Minami, Higashi-ku, Nagoya
TEL 052-719-1346
Email yamadas@met.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Masaya
Middle name
Last name Negishi
Organization Nagoya University
Division name Graduate School of Medicine (Health Sciences)
Zip code 461-8673
Address 1-1-20 Daiko-Minami, Higashi-ku, Nagoya
TEL 052-719-1876
Homepage URL
Email negishi.masaya@f.mbox.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Epson health insurance society
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Nagoya University Graduate School of Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya
Tel 052-744-2061
Email ethics@med.nagoya-u.ac.jp

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
2020 Year 04 Month 19 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 59
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 Completed
Date of protocol fixation
2020 Year 01 Month 09 Day
Date of IRB
2020 Year 01 Month 09 Day
Anticipated trial start date
2020 Year 01 Month 14 Day
Last follow-up date
2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 18 Day
Last modified on
2021 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045836

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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