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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046137
Receipt No. R000052644
Scientific Title A smartphone diet application with personalized advice to promote physical activity: A randomized controlled trial
Date of disclosure of the study information 2021/11/23
Last modified on 2021/11/19

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Basic information
Public title A smartphone diet application with personalized advice to promote physical activity: A randomized controlled trial
Acronym A diet app with personalized advice to promote physical activity
Scientific Title A smartphone diet application with personalized advice to promote physical activity: A randomized controlled trial
Scientific Title:Acronym A diet app with personalized advice to promote physical activity
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to examine the effect of a smartphone diet application with personalized advice for physical activity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Change in steps over three months.
Key secondary outcomes Changes in physical activity and the percentage of people with exercise habits over three months.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Use of a smartphone diet application without personalized advice for physical activity.
Interventions/Control_2 Use of a smartphone diet application with personalized advice for physical activity.
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
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Those who can install the diet application on their smartphones.
(2) Those who understand the purpose and contents of the study and provide written informed consent.
Key exclusion criteria (1) Those who have a history of heart disease or cerebrovascular disease.
(2) Those who have gait disturbance.
(3) Those who are currently pregnant or desire pregnancy during the study.
(4) Those who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Yoshio
Middle name
Last name NAKATA
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba
TEL 029-853-3957
Email nakata.yoshio.gn@u.tsukuba.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name NAKATA
Organization University of Tsukuba
Division name Faculty of Health and Sport Sciences
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba
TEL 029-853-3957
Homepage URL
Email nakata.yoshio.gn@u.tsukuba.ac.jp

Sponsor
Institute Link & Communication Inc.
Institute
Department

Funding Source
Organization Link & Communication Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Review Board of the Faculty of Health and Sport Sciences at the University of Tsukuba
Address 1-1-1 Tennodai, Tsukuba
Tel 029-853-2571
Email tg-kenkyurinri@un.tsukuba.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 11 Month 23 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 08 Month 06 Day
Date of IRB
2021 Year 10 Month 21 Day
Anticipated trial start date
2021 Year 11 Month 30 Day
Last follow-up date
2022 Year 03 Month 13 Day
Date of closure to data entry
2022 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 04 Month 30 Day
Date analysis concluded
2022 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 11 Month 22 Day
Last modified on
2021 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052644

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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