Cross-sectional Study: In phase I, face-to-face semi-structured interviews will be conducted with approximately 15 patients with T2DM and 15 relevant healthcare workers (clinicians and nurses) from the Department of Endocrinology and Metabolism at the Third Affiliated Hospital of Soochow University. Each interview will last 15-30 minutes and take place in a quiet setting, such as an inpatient ward or demonstration classroom. In phase II (scale validation) and phase III (survey), T2DM patients attending the same department will be recruited.
Study summary
This study aims to develop the Active Health Behavior Scale for Type 2 Diabetes Mellitus (T2DM) patients and evaluate its psychometric properties, including internal consistency reliability, test-retest reliability, content validity, construct validity, and criterion-related validity. Additionally, this research will investigate the current status of active health behaviors among T2DM patients and employ latent profile analysis (LPA) to identify distinct behavioral subtypes. Furthermore, differences in demographic, clinical, and psychosocial determinants across the identified latent classes will be examined to inform tailored intervention strategies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients with T2DM
1. Who have been diagnosed with T2DM and meet the diagnostic criteria defined by the Chinese Guideline for the Prevention and Treatment of Diabetes (2024 Edition);
2. Aged ≥18 years;
3. Who volunteer to participate in this study.
Healthcare workers:
1. Clinicians and nurses who have been engaged in medical care in the endocrine field for ≥5 years;
2. Who hold a Bachelor's degree or above and have an intermediate or above professional title.
Exclusion Criteria:
* Patients with T2DM:
1. Who have acute complications of T2DM or other serious life-threatening diseases that preclude cooperation with the study;
2. Who have cognitive impairment or are unable to communicate in writing or verbally
Healthcare workers:
1. Who do not have direct contact with patients;
2. Who are currently undergoing standardized training or refresher programs.
Primary outcome measure(s)
Total scale score of the Active Health Behavior Scale for Patients with Type 2 Diabetes Mellitus. — One year, from December 2025 to December 2026 The Active Health Behavior Scale for Patients with Type 2 Diabetes Mellitus will be developed and validated in Phase I and Phase II of this study, to assess the level of proactive health behaviors in patients with type 2 diabetes mellitus. The exact dimensions, number of items, and total score range of the scale will be finalized after study Phase II. A five-point Likert-type measurement will be used to answer each question, including 'very consistent, consistent, neutral, inconsistent, and very inconsistent'. Each response is assigned to a numerical value (from 1 to 5, e.g., 5 = very consistent and 1 = very inconsistent), where higher scores on the scale will indicate better proactive health behaviors in patients., allowing for quantitative analysis of the data collected in Phase III. The total score range of this scale will be determined by the final number of items.
Trial sites (1)
Facility
City
Region
Status
The Third Affiliated Hospital of Soochow University（THE FIRST PEOPLE'S HOSPITAL OF CHANGZHOU）
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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