SACCT-DM

Completed

• Conditions: Type 2 diabetes

• Registration Number: jRCT1060210053
• Lead Sponsor: Kenichi Shikata

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-27
• Study Start: 2022-01-05
• Last Update Posted: 2023-09-30

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

The patient meets all three criteria.

1. Patients with diabetes over 20 years old, HbA1c 6.5% or more, less than 10%, BMI 25 or more, less than 35
2. Patients who have been briefed, understood, and given written consent to participate in the study
3. Outpatient

Exclusion Criteria

Patients who fall under any of the four are excluded.

1. Patients who are restricted from exercising by a doctor or who have neuropathy that interferes with exercising
2. Patients with a history of myocardial infarction or cerebral infarction
3. Patients with a history of hospital visits or treatment for psychiatric disorders such as depression and schizophrenia
4. In addition, patients who are judged to be inappropriate as research subjects by the principal investigator or the research coordinator

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
Diabetes Treatment Satisfaction Questionnaire (DTSQ)	Before and after the program	A questionnaire to measure patient satisfaction, verified by Ishii et al.

Secondary Outcome Measures

Name	Time	Method
blood biochemical test		As a blood biochemical test, check HbA1c, triglyceride, HDL cholesterol, LDL cholesterol, and total cholesterol. These utilize test data performed in clinical practice.
stress coping ability (psychological flexibility)	before and after the program	Conduct a questionnaire to measure stress coping ability (psychological flexibility) before and after the program, and evaluate it by scoring it. To evaluate stress coping ability (psychological flexibility), we use a scale (Japanese version of Acceptance and Action Questionnaire-II (7 item version)) that measures avoidance of experiences verified by Shima et al.
weight	each visit	Measure the weight at each visit. These are indexes for evaluating the therapeutic effect in clinical practice.
abdominal circumference	start and end of the program	Measure the abdominal circumference at the start and end of the program. These are indexes for evaluating the therapeutic effect in clinical practice.