The efficacy of cognitive-behavioral therapy-based intervention on Type II diabetes patients with comorbid metabolic syndrome—a randomised controlled trial

Not Applicable

• Conditions: Type 2 diabetes; Metabolic syndrome; Public Health - Health promotion/education; Metabolic and Endocrine - Diabetes; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12621001348842
• Lead Sponsor: Grifftih University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-07
• Last Update Posted: 11 October 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Key inclusion criteria:
(1) The participants will be recruited from the Endocrinology Department of Ningbo First Hospital, Ningbo city, Zhejiang province, China. Recruited participants will be included in this research if they meet the following criteria:
1) Diagnosed type 2 diabetes (T2DM) with comorbid metabolic syndrome (MS);
2) Age 18-75 years old;
3) Currently does not participate in similar intervention programs;
4) Sign an informed consent form, willing to participate in this study, and have good compliance.
(2) The specific diagnostic criteria for diabetes refer to the report of the WHO Diabetes Expert Committee, 1999, which is as follows: typical symptoms of diabetes plus
1) random blood glucose greater than or equal to 11.1 mmol/L;
2) fasting blood glucose greater than or equal to 7.0 mmol/L;
3) oral glucose tolerance test 2 hours greater than or equal to 11.1 mmol/L;
4) When there is no definite hyperglycemia, it should be confirmed by repeated tests.
(3) The specific diagnostic criteria for metabolic syndrome refers to the IDF standard (Alberti et al., 2005; Collaborators):
central obesity, WC greater than or equal to 90cm (Chinese male) or greater than or equal to 80cm (Chinese female), and those who have 2 or more of the following components,
1) TG greater than or equal to 1.70mmol/L or have received relevant treatment;
2) HDL-C less than 1.03mmol/L (male) or less than 1.30mmol/L (female), or have received relevant treatment;
3) SBP greater than or equal to 130 or DBP greater than or equal to 85mmHg, or have received relevant treatment;
4) FPG greater than or equal to 5.6mmol/L or have been diagnosed with T2DM.

Exclusion Criteria

Participants will be excluded from the study if 1) T1DM; 2) they are pregnant; 3) taking medications unrelated to T2DM or MS; 4) had advanced diabetes complications; 5) had a severe mental illness, is not able to answer questions and participate in intervention activities; 6) cannot use the mobile phone.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c%) from the patient's medical records of Ningbo First Hospital.<br><br>[(1) At baseline; (2) Immediately after the intervention]