UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042045 |
|---|---|
| Receipt number | R000046495 |
| Scientific Title | The Effects of a Self-Management Supporting ICT System for Abdominal Obesity: A Prospective Randomized Control Study. |
| Date of disclosure of the study information | 2020/10/07 |
| Last modified on | 2021/03/22 12:23:18 |
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Basic information
Public title
The Effects of a Self-Management Supporting ICT System for Abdominal Obesity: A Prospective Randomized Control Study.
Acronym
The Effects of a Self-Management Supporting ICT System for Abdominal Obesity: A Prospective Randomized Control Study.
Scientific Title
The Effects of a Self-Management Supporting ICT System for Abdominal Obesity: A Prospective Randomized Control Study.
Scientific Title:Acronym
The Effects of a Self-Management Supporting ICT System for Abdominal Obesity: A Prospective Randomized Control Study.
Region
| Japan |
Condition
Condition
Abdominal obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the ICT-based self-management support system DialBetesLite on reducing abdominal obesity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparing the change in visceral fat area during the first 3 months of the study between the two groups, group A (intervention) and group B (no intervention)
Key secondary outcomes
1. Comparing change in BMI, waist circumference, blood pressure, HbA1c, fasting blood glucose, triglycerides, HDL cholesterol, LDL cholesterol, diet, self-management behaviors, and locomotive functions during the first 3 months of the study between the two groups, group A (intervention) and group B (no intervention)
2. Comparing visceral fat area, BMI, waist circumference, blood pressure, HbA1c, fasting blood glucose, triglyceride, HDL cholesterol, LDL cholesterol, diet, self-management behaviors, and locomotive functions at the beginning of intervention, at the end of the intervention (3rd month), and the end of the follow-up period (10th month) within group A to verify the long-term effects of the intervention
3. Comparing the change in visceral fat area during 3-month intervention period between group A (the first 3 months of the study) and group B (from the 6th to 9th month), to evaluate the effect of the comments by healthcare providers during the intervention (Group B receives intervention during the follow-up survey, while group B does not receive the comments by healthcare providers during the intervention).
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
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
"Group A; those who receive DialBetesLite intervention"
1. Group session at the beginning of the intervention (100 minutes)
-Lecture on lifestyle-related diseases and recommendations for diet and exercise (for 60 minutes)
-Lecture on usage of the system (for 40 minutes)
2. Intervention period (employing DialBetesLite)
*Comments by healthcare providers on participant's personal health records (PHRs) recorded to the system are provided to participants at the first month of the intervention period.
3. Group Session at the end of the intervention (for 60 minutes) at the 3rd month
4. The participants receive comments from healthcare providers on data recorded on DialBetesLite, and on the results of physical measurements and blood tests at the beginning of the study and the end of the intervention (3rd month).
5. 7-month follow-up period after the intervention
6. The participants receive comments from healthcare providers on the results of physical measurements and blood tests at the beginning of the intervention, the end of the intervention, and the end of follow-up survey.
Interventions/Control_2
"Group B; those who receive no intervention"
During the 7-month follow-up period, Group B also employs DialBetesLite for 3 months in accordance with the principle of beneficence.
1. No-intervention period for 3 months
2. 7-month follow up period
2-1.Group session at the beginning of the intervention (for 100 minutes)
-Lecture on lifestyle-related diseases and recommendations for diet and exercise (for 60 minutes)
-Lecture, with practice using the system (for 40 minutes)
2-2.intervention period for 3 months with DialBetesLite intervention (from 6th to 9th month)
*No comments by healthcare providers are provided during the intervention period.
2.3 Group Session at the end of the intervention (for 60 minutes)
3. The participants receive comments from healthcare providers on PHRs and the results of physical measurements and blood tests at the beginning of the study, 3rd month, and 10th month.
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Employees of a private company who are covered under its Health Insurance Society
-Who are willing to use the ICT system
-Whose waist circumference greater than 85 cm for males (90 cm for female) or BMI 25 or greater
-Who are satisfying more than one of the following conditions
1. Fasting plasma glucose 100 mg/dl or greater, or HbA1c 5.6 % or greater
2. triglyceride 150 mg/dl or greater, or HDL-cholesterol less than 40 mg/dl
3. Systolic blood pressure 130 mmHg or greater, or diastolic blood pressure 85 mmHg or greater
Key exclusion criteria
Those who receive any medication for treatments of hypertension, dyslipidemia or diabetes
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kayo |
| Middle name | |
| Last name | Waki |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Biomedical Informatics
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411(ext.34462)
dialbetics-office@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Miyake |
Organization
University of Tokyo Hospital, Japan
Division name
Department of Planning, Information and Management
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411(ext.34462)
Homepage URL
dialbetics-office@umin.ac.jp
Sponsor or person
Institute
Department of Biomedical Informatics, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Daiwa Securities Group Inc.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Daiwa Securities Group Health Insurance Society
Name of secondary funder(s)
NTT DOCOMO, INC.
IRB Contact (For public release)
Organization
Research Ethics Committee, Graduate School of Medicine and Faculty of Medicine, the University of Tokyo
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
| 2020 | Year | 10 | Month | 07 | 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
122
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
| 2017 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 07 | Day |
Last modified on
| 2021 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046495
