Development of a life style modification program to prevent severe diabetes by introducing a psychological approach; Toward commercialization of a healthcare business

Development of a life style modification program to prevent severe diabetes by introducing a psychological approach; Toward commercialization of a healthcare business - Development of a life style modification program to prevent severe diabetes by introducing a psychological approach

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019718

Enrollment

100

Registered

2016-01-01

Start date

2016-01-01

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

Diabetes, Prediabetes, Obesity

Interventions

Monthly Counseling for Life Style Modification (3 months) Monthly counseling for life style modification + EQ Enhancement Training (3 months) EQ Enhancement Training (3 months) Monthly Counseling

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diabetic/Prediabetic patients or obese individuals in entities with employees participating in a study, entitled 'A cohort study to reveal factors that contribute to the onset of diabetes/metabolic syndrome through a development of insulin resistance' or in health insurance union of Awa Bank, Limited, Tokushima Bank, Limited or Otsuka Pharmaceutical Co, Ltd. Diabetic patients are defined as individuals with FBS >= 126 mg/dl or HbA1c >= 6.5%, or individuals treated with anti-diabetic medication due to a diagnosis of diabetes. Prediabetic patients are defined as individuals with HbA1c >= 6.1% and < 6.5%. Obesity is defined as BMI >= 25.

Exclusion criteria

Exclusion criteria: 1. Individuals without written consents 2. Individuals with HbA1c >= 8.4%, or 2 hour post prandial glucose >= 220 mg/dl 3. Individuals with fundal hemorrhage. Individuals diagnosed with preproliferative or proliferative retinopathy, who are at risk of fundal hemorrhage. Individuals who have not consulted ophthalmologists despite of a presence of simple retinopathy. 4. Individuals with Stage 3 or higher diabetic nephlopathy 5. Individuals with a past history of severe cardiovascular events, such as cardiac infarction, or individuals who have been pointed out with abnormalities in their cardiovascular system at medical checkups 6. Individuals with diabetic autonomic neuropathy 7. Individuals with extremely poor metabolism (FBS >= 250 mg/dl or moderate or higher level of keton in urine) 8. Individuals with acute infection 9. Individuals with severe HT (Systolic BP >= 180 mmHg or Diastolic BP >=110 mmHg) 10. Individuals with orthopedic problems, such as bone/joint diseases 11. Individuals with diabetic gangrene 12. Individuals with exercise restriction by a doctor in charge

Design outcomes

Primary

Measure	Time frame
HbA1c (Baseline and 3 and 9 months after starting intervention)	—

Secondary

Measure	Time frame
The degree of achieving the goal of life style modification Anti-diabetic drug usage Body weight BMI Waist circumference	—

Countries

Japan

Contacts

Public ContactToshihiro Kanazawa

Tokushima Data Service Co. Ltd. Operating Officer

t.kanazawa@tds-inf.co.jp088-622-6188

Outcome results

None listed

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