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

April 11, 2026 updated by: Yun Ye
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213000
        • Recruiting
        • The Third Affiliated Hospital of Soochow University（THE FIRST PEOPLE'S HOSPITAL OF CHANGZHOU）
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Phase I (Interview, Dec 2025-Feb 2026): T2DM patients and relevant healthcare workers (n ≈ 30) from the Third Affiliated Hospital of Soochow University.

Phase II (Scale validation, Jun-Sep 2026): T2DM patients (n ≈ 300) at the same hospital.

Phase III (Survey, Oct-Dec 2026): T2DM patients (sample size to be determined) at the same hospital.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with type 2 diabetes, as well as healthcare workers (clinicians and nurses)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total scale score of the Active Health Behavior Scale for Patients with Type 2 Diabetes Mellitus.
Time Frame: 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.
One year, from December 2025 to December 2026

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yun Ye

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2025

Primary Completion (Estimated)

February 20, 2027

Study Completion (Estimated)

February 20, 2027

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 11, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (2026) Education No. 014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Individual participant data (IPD) will be available to other researchers on request after the results being published. There will not be any time limitation.

IPD Sharing Access Criteria

Other researchers, e.g., systematic review authors, will be able to obtain the IPD on request. Please contact the primary investigator of this study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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