UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040195
Receipt number 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 15:58:00

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Nagoya University

Institute

Department

Personal name



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

Value
https://center6.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