UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033397 |
|---|---|
| Receipt number | R000037956 |
| Scientific Title | The effect of using smartphone application during weight loss support on step counts |
| Date of disclosure of the study information | 2019/02/10 |
| Last modified on | 2021/11/08 06:47:06 |
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Basic information
Public title
The effect of using smartphone application during weight loss support on step counts
Acronym
The effect of using smartphone application during weight loss support on step counts
Scientific Title
The effect of using smartphone application during weight loss support on step counts
Scientific Title:Acronym
The effect of using smartphone application during weight loss support on step counts
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of increasing the step counts by sharing the step counts information using the smartphone application.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Step counts
After 12 weeks and 32 weeks from the start of intervention
Key secondary outcomes
Weight, physical activity pattern, energy intake, sleep patterns, subjective appetite,
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1. self-management (energy restriction and the increase of physical activity)
2. daily weight measurement
Interventions/Control_2
1. self-management (energy restriction and the increase of physical activity)
2. daily weight measurement
3. sharing the step counts information using the smartphone application
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. BMI 20 or more
2. those who feel the necessity of weight reduction
3. daily smartphone user
Key exclusion criteria
In case of subjects with disease, subject who did not permit to participate from family doctor.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | YOSHIMURA |
| Middle name | |
| Last name | EIICHI |
Organization
Prefectural University of Kumamoto
Division name
Department of Food and Health Sciences
Zip code
8628502
Address
3-1-100 Higashi-ku Tsukide, Kumamoto
TEL
096-383-2929
publichealth-kku@umin.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimura |
| Middle name | |
| Last name | Eiichi |
Organization
Prefectural University of Kumamoto
Division name
Faculty of Environmental and Symbiotic Sciences
Zip code
8628502
Address
3-1-100 Tsukide, Higashi-ku, Kumamoto
TEL
096-383-2929
Homepage URL
publichealth-kku@umin.ac.jp
Sponsor or person
Institute
Prefectural University of Kumamoto
Institute
Department
Personal name
Funding Source
Organization
Japan Society For The Promotion Of Science
Grant-in-Aid for Scientific Research (A)
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
Prefectural University of Kumamoto
Address
3-1-100 Tsukide Higashi-ku Kumamoto
Tel
096-383-2929
renkei-c@pu-kumamoto.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
熊本県立大学
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 10 | 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
110
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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 15 | Day |
Last modified on
| 2021 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037956
