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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045630
Receipt No. R000052092
Scientific Title Practicality of using wearable devices to measure energy expenditure and activity measurement using wearable devices
Date of disclosure of the study information 2021/10/01
Last modified on 2021/10/01

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Basic information
Public title Practicality of using wearable devices to measure energy expenditure and
activity measurement using wearable devices
Acronym Practicality of using wearable devices to measure energy expenditure and
activity measurement using wearable devices
Scientific Title Practicality of using wearable devices to measure energy expenditure and
activity measurement using wearable devices
Scientific Title:Acronym Practicality of using wearable devices to measure energy expenditure and
activity measurement using wearable devices
Region
Japan

Condition
Condition People who have no serious health problems and are able to lead a normal life, even if they have to go to hospital or take medication.
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to determine the practicality of using a wearable device body movement centre (ActiGraph) to measure energy consumption and activity. Practicality is defined as validity, simplicity, safety (invasiveness) and usability.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Data measured by the ActiGraph body movement sensor: energy expenditure, activity, sleep time, heart rate
2. Body composition data: basal metabolic rate, muscle mass, body fat percentage, body weight
3. Questionnaire: age, sex, height, weight, medical history, dietary records, activity records, feeling of use, presence of adverse events
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Those who have consented to participate in the study
(ii) Those who are able to take measurements with an impedance body composition meter*1
3) Those who have no difficulty in daily life at home*2

*1 Body composition scales are available in the Nutrition Support and Care Laboratory.
*2 Those with underlying medical conditions such as diabetes or obesity may participate in the study, but not those who have been instructed by their physician not to cooperate in the survey.
Key exclusion criteria (1) Those who are hospitalized
(2) Those who are regularly attending hospital for serious illnesses such as dialysis or cancer chemotherapy
(3) Those who are judged by the doctor to be unable to endure the survey due to serious mental illness or underlying disease.
(4) Those who are unable to communicate in Japanese.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Saori
Middle name
Last name Koshimoto
Organization Tokyo Kasei Gakuin University
Division name Department of Human Nutrition
Zip code 102-8341
Address 22 Sanban-cho, Chiyoda-ku, Tokyo
TEL 81-3-3262-2251
Email s_koshi@kasei-gakuin.ac.jp

Public contact
Name of contact person
1st name Saori
Middle name
Last name Koshimoto
Organization Tokyo Kasei Gakuin University
Division name Department of Human Nutrition
Zip code 102-8341
Address 22 Sanban-cho, Chiyoda-ku, Tokyo
TEL 81-3-3262-2251
Homepage URL
Email s_koshi@kasei-gakuin.ac.jp

Sponsor
Institute Tokyo Kasei Gakuin University
Institute
Department

Funding Source
Organization Tokyo Kasei Gakuin 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 Tokyo Kasei Gakuin University
Address 22 Sanbancho, Chiyoda-ku, Tokyo
Tel 81-3-3262-2251
Email s_koshi@kasei-gakuin.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
2021 Year 10 Month 01 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
2021 Year 09 Month 21 Day
Date of IRB
2021 Year 09 Month 21 Day
Anticipated trial start date
2021 Year 10 Month 01 Day
Last follow-up date
2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional research

Management information
Registered date
2021 Year 10 Month 01 Day
Last modified on
2021 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052092

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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