Study on Effectiveness Verification of Specific Health Guidance Utilizing Information and Communications Technology (ICT)

JRCT ID: jRCT1090220315

Registered date:16/11/2017

Basic Information

• Recruitment status: COMPLETED
• Health condition(s) or Problem(s) studied: Lifestyle-related diseases
• Date of first enrollment: 01/12/2017
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention type:BEHAVIOUR
Name of intervention:Lifestyle improvement by health guidance utilizing information technology(IT)
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:Lifestyle improvement by standard health guidance
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: Variation in the body weight (kg) between the baseline and 3 months
• Secondary Outcome: Variations (continuous values) in the items described below during the study duration, between the baseline and 3 months, or onset (categorical value)

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 64age old
• Gender: Both

Include criteria

Those who satisfy all of the following conditions:
1. Person who has received the specific health check-up and been assigned to the active support group
2. Age: Males and females between 40 and 64 years old
3. Person who has smartphone
4. Person who satisfies the following essential item (1) as well as two or more of other items from (2) to (5):
(1) Male: Waist circumference 85cm or more; Female: waist circumference 90cm or more
(2) TG 150 mg/dl or more
(3) HDL cholesterol less than 40 mg/dl
(4) SBP 130 mmHg or more, and/or DBP 85 mmHg or more
(5) FPG 110 mg/dl or more
5. Person taking no drugs related to weight loss and metabolic syndrome (except for vitamin supplements)

Exclude criteria

1. Person who has a history of cerebral cardiovascular disease
2. Person with lung disease
3. Person who cannot expect to continue the participation for
6 months (for example, scheduled moving within 6 months etc.)
4. Person judged by doctors that participation is not appropriate
5. Person who is pregnant
6. Person taking drugs related to weight loss or metabolic syndrome (diabetes, hypertension, hyperlipidemia) (except for vitamin supplements)

Related Information

• Primary Sponsor: Yumi Matsushita
• Source(s) of Monetary Support: Miyagi Prefecture Higashimatsushima
• Secondary ID(s): Nill Known,JMA-IIA00315