RecruitingNCT07531459

Compilation and Preliminary Application of the Active Health Behavior Scale in Patients With Type 2 Diabetes


Sponsor

Yun Ye

Enrollment

600 participants

Start Date

Dec 24, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria7

  • Patients with T2DM
  • 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);
  • Aged ≥18 years;
  • Who volunteer to participate in this study.
  • Healthcare workers:
  • Clinicians and nurses who have been engaged in medical care in the endocrine field for ≥5 years;
  • Who hold a Bachelor's degree or above and have an intermediate or above professional title.

Exclusion Criteria6

  • Patients with T2DM:
  • Who have acute complications of T2DM or other serious life-threatening diseases that preclude cooperation with the study;
  • Who have cognitive impairment or are unable to communicate in writing or verbally
  • Healthcare workers:
  • Who do not have direct contact with patients;
  • Who are currently undergoing standardized training or refresher programs.

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Interventions

OTHERCross-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.


Locations(1)

The Third Affiliated Hospital of Soochow University(THE FIRST PEOPLE'S HOSPITAL OF CHANGZHOU)

Changzhou, Jiangsu, China

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NCT07531459


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