UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038813 |
|---|---|
| Receipt number | R000044253 |
| Scientific Title | Examination of obesity improvement effect by introducing smartphone application for obese patients |
| Date of disclosure of the study information | 2019/12/06 |
| Last modified on | 2019/12/06 16:58:15 |
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Basic information
Public title
Examination of obesity improvement effect by introducing smartphone application for obese patients
Acronym
Examination of obesity improvement effect by introducing smartphone application for obese patients
Scientific Title
Examination of obesity improvement effect by introducing smartphone application for obese patients
Scientific Title:Acronym
Examination of obesity improvement effect by introducing smartphone application for obese patients
Region
| Japan |
Condition
Condition
Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate the effects on body weight and metabolic parameters by smartphone application for obese patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Height, weight, waist circumference, BMI, blood pressure, Blood and biochemistry data(Total cholesterol, neutral fat, HDL cholesterol, LDL cholesterol, BNP,UA,BUN,Cre, AST, ALT,GTP), Body composition by In Body measurement, Muscle strength(Knee extensor strength, grip strength),Development of obesity-related diseases
Key secondary outcomes
N/A
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
Obese patients with BMI 25kg/m2 or more, and who are visiting National Center for Global Health and Medicine,Kounodai hospital.
Key exclusion criteria
Patients under 20 years old.
Patients who have difficulty in daily activities because of ADL decline.
Patients who are pregnant or plan to become pregnant.
Patients with secondary obesity.
Patients with eating disorders.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Hidekatsu |
| Middle name | |
| Last name | Yanai |
Organization
National Center for Global Health and Medicine
Division name
Department of Internal Medicine
Zip code
272-0034
Address
1-7-1 Kohnodai, Ichikawa, Chiba, Japan
TEL
+81-47-272-0034
dyanai@hospk.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Hidekatsu |
| Middle name | |
| Last name | Yanai |
Organization
National Center for Global Health and Medicine
Division name
Department of Internal Medicine
Zip code
272-0034
Address
1-7-1 Kohnodai, Ichikawa, Chiba, Japan
TEL
+81-47-272-0034
Homepage URL
dyanai@hospk.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine Kohnodai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
none
Address
none
Tel
none
none
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
国立国際医療研究センター国府台病院(千葉)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 06 | 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
38
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 12 | Month | 06 | Day |
Last modified on
| 2019 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044253
