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Evaluation of the effects of lifestyle improvement for type 2 diabetes patients: behavior type specific approach with the implementation of two clinical trials

Evaluation of the effects of lifestyle improvement for type 2 diabetes patients: behavior type specific approach with the implementation of two clinical trials - Evaluation of the effects of lifestyle improvement for type 2 diabetes patients with behavior type specific approach

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023087
Enrollment
288
Registered
2016-07-08
Start date
2018-04-16
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

Type 2 diabetes

Interventions

To conduct 6 months personal lifestyle education(SILE) for type2 daiabetes. The SILE is performed according to the procedure of Nutrition Care Management. For the period from the first counseling sess

Sponsors

Teikyo University, Graduate School of Public Health
Lead Sponsor
Center for Medical Statistics, Showa Women&#39
Collaborator
s University
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who gave a written informed consent with complete understanding, after receiving a sufficient description of the study 2. Patients above the age of 20 up to 79 years when the consent is received 3. Patients meeting the criteria of 6.5% (NGSP) or more for HbA1c 4. Patients who are yet to start the therapy based on diabetes drugs, or those who are on oral drugs and insulin injections for diabetes, and the attending physician determines that there is almost no change in the HbA1c levels.(Almost no change observed in the status means that the maximum difference in HbA1c levels over a period of 3 months was less than 0.2 points.)

Exclusion criteria

Exclusion criteria: 1. Patients from whom consent cannot be obtained 2. Patients with type 1 diabetes 3. Patients with gestational diabetes 4. Diabetic retinopathy: Patients with proliferative retinopathy 5. Diabetic nephropathy: Patients with stage 3 or more 6. Patients determined by the doctor as having difficulty in filling the questionnaire

Design outcomes

Primary

MeasureTime frame
The difference between the two groups for the change from baseline of the HbA1c levels at six months (plus or minus 1 month) from the first counseling session.

Secondary

MeasureTime frame
The changes from baseline for BMI, FBS, LDL, HDL, TG, SBP/DBP, dietary intake(energy, fat energy ratio etc), Change of health behavior and awarness

Countries

Japan

Contacts

Public ContactMisa Adachi

Nutrition Support Network LLC Research & Development Dept

adachi@nutrisupport.co.jp042-765-6393

Outcome results

None listed

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