UMIN-CTR Clinical Trial

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

Abdominal obesity

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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).

Study type

Interventional

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

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

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

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)

Email

dialbetics-office@umin.ac.jp

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

Email

dialbetics-office@umin.ac.jp

Institute

Department of Biomedical Informatics, Graduate School of Medicine, The University of Tokyo

Institute

Department

Personal name

Organization

Daiwa Securities Group Inc.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Daiwa Securities Group Health Insurance Society

Name of secondary funder(s)

NTT DOCOMO, INC.

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

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

10

Month

07

Day

URL releasing protocol

https://u-tokyo.bvits.com/esct/Apply/projectlist_project.aspx?PROJECT_ID=5962&ROLE=45

Publication of results

Published

URL related to results and publications

https://formative.jmir.org/2022/3/e33852

Number of participants that the trial has enrolled

122

Results

Of 122 participants, 47 were excluded, leaving 75 for analysis. There were no baseline differences between the intervention (49.3y) and control (48.5y) groups. The intervention group showed VFA reduction (-23.5 vs +1.9 cm2) and improved weight, BMI, and waist. VFA reduction correlated with steps and calorie intake; median app use was 100%, suggesting mHealth reduced visceral fat and weight.

Results date posted

2025

Year

10

Month

21

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2022

Year

03

Month

24

Day

Baseline Characteristics

Participants were recruited from employees of a securities company located in Tokyo through advertisements distributed via email and the companys internal intranet. This company is one of Japans leading securities firms with an average annual employee income of approximately 10 million yen USD 85000. We recruited participants who were enrolled in the national Specific Health Guidance program and were willing to use an ICT based system via smartphone. Eligible participants in the Specific Health Guidance program were between 40 and 75 years of age and met both of the following criteria 1 waist circumference WC of at least 85 cm for men or at least 90 cm for women or a body mass index BMI of at least 25 kg/m2 and 2 at least one of the following three metabolic abnormalities i hyperglycemia fasting plasma glucose of at least 100 mg/dL or HbA1c of at least 5.6 percent ii hypertriglyceridemia triglycerides of at least 150 mg/dL or low HDL cholesterol HDL less than 40 mg/dL or iii hypertension systolic blood pressure of at least 130 mmHg or diastolic blood pressure of at least 85 mmHg. Participants taking medications for hypertension dyslipidemia or diabetes mellitus were excluded. All eligible participants had abdominal obesity AO defined as a WC of at least 85 cm for men or at least 90 cm for women. The WC values used were obtained from annual health checkups conducted to screen for AO.

Participant flow

All participants provided written informed consent before the trial commenced; they were informed of their right to withdraw from the study at any time and how the data collected from the study would be used. This included an explanation of how data would be accessible to the research team to be used for analysis and dissemination, following the conclusion of the trial. Any results obtained from analyzing these data were to be presented at major domestic and international scientific conferences and submitted for peer-reviewed journals of international repute and visibility.

Adverse events

None

Outcome measures

Compare (primary outcome measures) between the early intervention group and the late intervention group. Furthermore, compare changes in BMI, waist circumference, blood pressure, HbA1c, fasting blood glucose, lipids, dietary content, lifestyle habits, and locomotive syndrome (secondary outcome measures) between the early intervention group and the late intervention group at three time points: at consent acquisition, 3 months after trial initiation, and at trial completion.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

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 related information

Registered date

2020

Year

10

Month

07

Day

Last modified on

2025

Year

10

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046495