UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048667 |
|---|---|
| Receipt number | R000055166 |
| Scientific Title | A feasibility study on a smartphone application for patients with obesity |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2026/03/03 06:51:15 |
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Basic information
Public title
A feasibility study on a smartphone application for patients with obesity
Acronym
A feasibility study on a smartphone application for patients with obesity
Scientific Title
A feasibility study on a smartphone application for patients with obesity
Scientific Title:Acronym
A feasibility study on a smartphone application for patients with obesity
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of a smartphone application for patients with obesity.
Basic objectives2
Others
Basic objectives -Others
Nothing in particular
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At 4 weeks after the start of the intervention
- Completion rate
- Continuous application use days
Key secondary outcomes
At 4 weeks after the start of the intervention
- Evaluation of the usability of the application
- Brief-type self-administered diet history questionnaire
- International physical activity questionnaire long version
- Emotion
- Weight
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
4 weeks of standard treatment with a smartphone application
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Patients in outpatient treatment for obesity disease diagnosed using the definition of the Japan Society for Study of Obesity.
- Patients aged >= 18 years
- Patients who can use a smartphone
Key exclusion criteria
- Patients with severe physical or mental diseases
- When the burden of investigation is considered undesirable for the medical condition
- Patients who seem to lack the ability to make decisions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yoshiuchi |
Organization
The University of Tokyo Hospital
Division name
Department of Psychosomatic Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9764
kyoshiuc-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kurisu |
Organization
The University of Tokyo Hospital
Division name
Department of Psychosomatic Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9764
Homepage URL
chrischris0801@gmail.com
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research Ethics Committee, Graduate School of Medicine
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2023 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.2196/77323
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.2196/77323
Number of participants that the trial has enrolled
20
Results
All 20 recruited individuals with obesity completed the study. The median app use rate was 98.3%. A significant improvement was observed in BMI (median at start 34.9 kg/m2; median at end 34.1 kg/m2). A significant association between higher preceding depressive mood levels and fewer behaviors was shown.
Results date posted
| 2026 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty individuals with obesity
Participant flow
The participants used the app for 4 weeks.
Adverse events
None
Outcome measures
- App use rate
- Changes in BMI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 14 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 14 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 15 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055166
