UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038982
Receipt number R000024574
Scientific Title Study on the compatibility and validity for the estimation in amount of physical activity and energy expenditure.
Date of disclosure of the study information 2019/12/31
Last modified on 2019/12/25 09:48:14

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Basic information

Public title

Study on the compatibility and validity for the estimation in amount of physical activity and energy expenditure.

Acronym

Physical activity estimation study

Scientific Title

Study on the compatibility and validity for the estimation in amount of physical activity and energy expenditure.

Scientific Title:Acronym

Physical activity estimation study

Region

Japan


Condition

Condition

None

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of the study was to clarify the validity and compatibility of measuring physical activity and energy expenditure using by wearable devices and questionnaires.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

physical activity, energy expenditure

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

20 years-old <=

Age-upper limit

50 years-old >=

Gender

Male and Female

Key inclusion criteria

Participants were nineteen healthy adults who were not obese and had no problems in daily activities.

Key exclusion criteria

BMI<18.5, >=25
Patients suffering from severe diseases such as myocardial infarction and cancer

Target sample size

18


Research contact person

Name of lead principal investigator

1st name Motohiko
Middle name
Last name Miyachi

Organization

National Institute of Health and Nutrition, NIBIOHN

Division name

Department of Health Promotion and Exercise

Zip code

162-9636

Address

1-23-1 Toyama, Shinjuku, Tokyo, Japan

TEL

03-3203-8061

Email

miyachi@nih.go.jp


Public contact

Name of contact person

1st name Motohiko
Middle name
Last name Miyachi

Organization

National Institute of Health and Nutrition, NIBIOHN

Division name

Department of Health Promotion and Exercise

Zip code

162-8636

Address

1-23-1 Toyama, Shinjuku, Tokyo, Japan

TEL

03-3203-8061

Homepage URL


Email

miyachi@nih.go.jp


Sponsor or person

Institute

National Institute of Health and Nutrition, NIBIOHN

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Institutes of Biomedical Innovation, Health and Nutrition

Address

Department of Physical Activity Research

Tel

072-641-9811

Email

irb-office@nibiohn.go.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

2019 Year 12 Month 31 Day


Related information

URL releasing protocol

https://mhealth.jmir.org/2019/8/e13938/

Publication of results

Published


Result

URL related to results and publications

https://mhealth.jmir.org/2019/8/e13938/

Number of participants that the trial has enrolled

19

Results

Although wearable devices for estimating energy expenditure are becoming increasingly popular, there is little evidence regarding their validity.
The wearable devices that we tested were able to rank daily total energy expenditure between individuals, but absolute values differed widely among devices and varied significantly from the gold standard measures.
Furthermore, all wearable devices underestimated total energy expenditure under free-living conditions.

Results date posted

2019 Year 12 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2016 Year 05 Month 01 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 02 Month 01 Day

Date of IRB

2016 Year 08 Month 04 Day

Anticipated trial start date

2015 Year 02 Month 10 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information

The research results are published as follows.
In the future more than one paper will be made public.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2500062
https://www.ncbi.nlm.nih.gov/pubmed/26999758
https://www.ncbi.nlm.nih.gov/pubmed/27598760
https://www.ncbi.nlm.nih.gov/pubmed/29709888
https://www.ncbi.nlm.nih.gov/pubmed/31376273


Management information

Registered date

2019 Year 12 Month 25 Day

Last modified on

2019 Year 12 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024574


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name