Clinical study on the usefulness of program for preventing lifestyle- related disease using Internet- based cognitive behavioral therapy

JRCT ID: jRCT1090220144

Registered date:21/10/2013

Basic Information

• Recruitment status: PENDING
• Health condition(s) or Problem(s) studied: Lifestyle-related diseases
• Date of first enrollment: 01/10/2013
• Target sample size: 60
• Countries of recruitment: Vietnam
• Study type: Interventional

Intervention(s)

Intervention type:BEHAVIOUR
Name of intervention:improvement of lifestyle using IT system
Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE
Route of administration / Site of application:NOT APPLICABLE
Dose per administration:
Dosing frequency / Frequency of use:
Planned duration of intervention:3 months
Intended dose regimen:
detailes of teratment arms:
Comparative intervention name:improvement of lifestyle using a leaflet
Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE
Route of administration / Site of application:NOT APPLICABLE
Dose per administration:
Dosing frequency / Frequency of use:
Planned duration of intervention:3 months
Intended dose regimen:

Outcome(s)

• Primary Outcome: The weight change (kg) between pre-intervention and three-month post-intervention.
• Secondary Outcome: The metabolic syndrome factors during the trial and the change (continuous variable) or occurrence (category variable) of inflammatory markers

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 59age old
• Gender: Both

Include criteria

The subjects need to satisfy all of the following conditions (at the second screening):
*Employed at a bank or a school
*Age 40-59
*Have access to the Internet at home or
workplace

*Have three or more of the following
conditions:
(1) TG >= 150 mg/dl
(2) HDL cholesterol < 40 mg/dl
(3) SBP >= 130 mmHg and/or DBP >= 85 mmHg
(4) FPG >= 110 mg/dl
(5) BMI >= 25 kg/m2 and/or
waist circumference:
>= 90 cm (male), >= 80 cm (female)
*Do not currently take medication for weight
loss or metabolic syndrome (vitamin
supplements are excluded)

Exclude criteria

The subjects who have at least one of
the following conditions are excluded:
*Have a history of cerebrovascular or cardiovascular diseases
*Have lung diseases
*Likely to not be able to participate
in the whole duration (3 months) of the
trial (e.g., moving)
*Judged ineligible by doctor

Related Information

• Primary Sponsor: Yumi Matsushita
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): JMA-IIA00144