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The Effects of a Self-Management Supporting ICT System for Abdominal Obesity: A Prospective Randomized Control Study.

The Effects of a Self-Management Supporting ICT System for Abdominal Obesity: A Prospective Randomized Control Study. - The Effects of a Self-Management Supporting ICT System for Abdominal Obesity: A Prospective Randomized Control Study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042045
Enrollment
150
Registered
2020-10-07
Start date
2017-09-23
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal obesity

Interventions

&quot
Group A
those who receive DialBetesLite intervention&quot
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
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)
Group B
those who receive no intervention&quot
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 pe

Sponsors

Department of Biomedical Informatics, Graduate School of Medicine, The University of Tokyo
Lead Sponsor
Daiwa Securities Group Health Insurance Society
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Those who receive any medication for treatments of hypertension, dyslipidemia or diabetes

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactKana Miyake

University of Tokyo Hospital, Japan Department of Planning, Information and Management

dialbetics-office@umin.ac.jp03-3815-5411(ext.34462)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026