UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050283
Receipt number R000057258
Scientific Title Effect of sitting and standing activities on daily energy expenditure
Date of disclosure of the study information 2023/02/09
Last modified on 2023/02/09 14:13:30

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Basic information

Public title

Effect of sitting and standing activities on daily energy expenditure

Acronym

Effect of sitting and standing activities on daily energy expenditure

Scientific Title

Effect of sitting and standing activities on daily energy expenditure

Scientific Title:Acronym

Effect of sitting and standing activities on daily energy expenditure

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to determine the effects of standing and sitting activities on daily energy expenditure.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To compare the daily energy expenditure of different postures and

Key secondary outcomes



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

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

1. Spend 8:30-20:30 in a standing position (sitting position only during meals)
2. Spend 8:30-20:30 in a sitting position

After erformed 1, do 2

Interventions/Control_2

1. Spend 8:30-20:30 in a standing position (sitting position only during meals)
2. Spend 8:30-20:30 in a sitting position

After erformed 2, do 1

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

18 years-old <=

Age-upper limit

44 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Subjects who can make self-judgment and are voluntarily giving written informed consent.
2. Subjects whose age 18 to 44 years old for Japanese.

Key exclusion criteria

1.Do not meet the above criteria
2.Who are not prohibited from exercising by a doctor.
3.Subjects who have diabetes
4.Subjects who have past surgical history of gastroenterological surgery.
5.Past medical history of kidney disease.
6.Subjects who use pharmaceuticals regularly.
7.Subjects who excessive alcohol intake
and who have a smoking habit.
8.Subjects who is irregular eating habits.
9.Subjects who are participating or will participate other clinical trials.
10.Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

9


Research contact person

Name of lead principal investigator

1st name Yamamoto
Middle name
Last name Taiki

Organization

Fukuoka University

Division name

Faculty of Sports and Health Science

Zip code

814-0180

Address

8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan

TEL

092-871-6631

Email

t.yamamoto.lh@adm.fukuoka-u.ac.jp


Public contact

Name of contact person

1st name Yamamoto
Middle name
Last name Taiki

Organization

Fukuoka univercity

Division name

Faculty of Sports and Health Science

Zip code

814-0180

Address

8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan

TEL

092-871-6631

Homepage URL


Email

t.yamamoto.lh@adm.fukuoka-u.ac.jp


Sponsor or person

Institute

Fukuoka University

Institute

Department

Personal name

Yamamoto Taiki


Funding Source

Organization

Fukuoka University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Fukuoka University

Address

8-19-1, Nanakuma, Jonan-ku, Fukuoka City, Fukuoka, 814-0180, Japan

Tel

092-871-6631

Email

t.yamamoto.lh@adm.fukuoka-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

福岡大学(福岡県)


Other administrative information

Date of disclosure of the study information

2023 Year 02 Month 09 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

Preinitiation

Date of protocol fixation

2022 Year 12 Month 12 Day

Date of IRB

2022 Year 12 Month 12 Day

Anticipated trial start date

2023 Year 04 Month 01 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 02 Month 09 Day

Last modified on

2023 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057258