NCT07531459

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Yun Ye · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Diabetes Mellitus (DM) is a metabolic disorder characterized by insulin secretion deficiency or impaired insulin utilization, with elevated blood glucose as its primary feature. Data show that China has over 140 million DM patients, accounting for 25% of the global DM population and ranking first worldwide. Clinical DM includes Type 1 DM (T1DM), Type 2 DM (T2DM), and other specific types, among which T2DM is the most common, comprising over 90% of all DM cases globally. Unlike T1DM, which results from autoimmune destruction of pancreatic β-cells, T2DM arises from the combined effects of genetic factors and unhealthy lifestyles (such as high-fat diets and physical inactivity), leading to abnormal elevation of blood glucose levels. As its development involves numerous modifiable risk factors, T2DM is regarded as a "lifestyle-related disease." Poor lifestyle among T2DM patients can result in inadequate glycemic control, subsequently causing various disabling or even life-threatening complications Therefore, a healthy lifestyle constitutes the cornerstone for preventing and treating T2DM and its complications; effective glycemic control through health behaviors, with achievement of stable and target glucose levels, represents the key to preventing and delaying the onset and progression of complications. Therefore, T2DM patients urgently need to proactively adopt and maintain healthy behaviors including healthy dietary patterns, regular physical exercise, smoking cessation, and healthy body weight maintenance to effectively control blood glucose, prevent complications, and improve their quality of life. Proactive Health Behavior refers to a series of health behaviors that individuals actively adopt and persistently maintain throughout the life-cycle health management process, including healthy diet, exercise, smoking cessation and alcohol limitation, regular sleep schedule, etc. Individuals with such behavior pay close attention to their health risks, give full play to their subjective initiative, strive to overcome obstacles in disease prevention and treatment, and promote physical, psychological, and social well-being. Previous studies have shown that when patients with T2DM consciously improve their dietary structure and increase the intake of dietary fiber and plant protein, the risk of diabetic retinopathy is reduced by approximately 47%, and the risk of stroke-related mortality is reduced by approximately 60%. Patients who actively exercise more than once per week have 1.32 times greater effectiveness in blood glucose control compared to those who exercise less than once per week. Higher frequency of self-monitoring of blood glucose and better medication adherence are more conducive to disease control. Therefore, promoting proactive health behavior among T2DM patients is not only an effective means of optimizing various clinical indicators, but also of significant importance for preventing complications and improving patients' overall health status and quality of life. This study aims to develop and validate the "Active Health Behavior Scale for T2DM Patients", consisting of three phases. Phase I: developing the initial draft of the scale through literature analysis, semi-structured interviews, and Delphi expert consultation; Phase II: reliability and validity testing. Phase III: using the scale developed in phase I and phase II to conduct a survey. The statistical methods of this study are as follows:This study will use R software,or SPSS, or Mplus for statistical analysis. Firstly, in the scale development stage, item selection and optimization will be conducted using the critical ratio method, correlation analysis, Cronbach's α coefficient, or exploratory factor analysis. Secondly, in the scale validation stage, validity will be evaluated through content validity (I-CVI and S-CVI), structural validity (exploratory and confirmatory factor analysis), construct validity (AVE and CR), and criterion-related validity. Reliability will be assessed using Cronbach's α coefficient, split-half reliability, and test-retest reliability. Finally, in the third stage (survey phase), latent profile analysis will be performed to identify latent classes of proactive health behaviors among patients with T2DM, and univariate analysis as well as multivariate regression analysis will be conducted to explore the influencing factors.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2025-12-24
• Primary completion: 2027-02-20
• Completion: 2027-02-20
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: China