UMIN-CTR Clinical Trial

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