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

NCT07531459 | Recruiting

• 1 other identifier: (2026) Education No. 014
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; scale; Active health behaviors

Outcome Measures

Primary Outcomes (1)

• Total scale score of the Active Health Behavior Scale for Patients with Type 2 Diabetes Mellitus.

  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

Study Arms (1)

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

Interventions

Cross-sectional Study OTHER

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.

Patients with type 2 diabetes, as well as healthcare workers (clinicians and nurses)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yun Ye: lead

Study Sites (1)

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

Changzhou, Jiangsu, 213000, China

RECRUITING

Related Publications (9)

• FEDERATION I D. Types of diabetes[EB/OL]. https://idf.org/.

  RESULT

• Wang MD, Gao WJ, Chen MX, et al. Concept analysis of proactive health behavior. Chinese Journal of Modern Nursing, 2025, 31(30): 4194-4200.

  RESULT

• Guo Y, Gu JP, Zhu DM, et al. Application effect of "Internet + nursing service" during insulin therapy in children with diabetes. Chinese Journal of Drug Abuse Prevention and Treatment, 2024, 30(4): 774-776.

  RESULT

• Li Y, Wang JG, Zhang HJ. Investigation on medication adherence among elderly patients with type 2 diabetes in the community. Chinese Journal of Drug Abuse Prevention and Treatment, 2024, 30(2): 252-254.

  RESULT

• Shi Z, Zhang XK. Medication use and glycemic control among patients with type 2 diabetes in Henan Province. Journal of Binzhou Medical University, 2025, 48(4): 413-417.

  RESULT

• Zhou YC, Liu JM, Zhao ZP, Zhou MG, Ng M. The national and provincial prevalence and non-fatal burdens of diabetes in China from 2005 to 2023 with projections of prevalence to 2050. Mil Med Res. 2025 Jun 2;12(1):28. doi: 10.1186/s40779-025-00615-1.

  PMID: 40457495 RESULT

• Duncan BB, Magliano DJ, Boyko EJ. IDF Diabetes Atlas 11th edition 2025: global prevalence and projections for 2050. Nephrol Dial Transplant. 2025 Dec 23;41(1):7-9. doi: 10.1093/ndt/gfaf177. No abstract available.

  PMID: 40874767 RESULT

• H E R I F. Global Burden of Disease Collaborative Network.Global Burden of Disease Study 2021[EB/OL]. https://vizhub.healthdata.org/gbd-results/.

  RESULT

• Sone H, Horikawa C, Tanaka-Mizuno S, Kawasaki R, Fujihara K, Moriya T, Araki A, Tanaka S, Akanuma Y. Japan Diabetes Complications Study: Revisiting one of the first large-scale clinical studies in East Asians with diabetes. J Diabetes Investig. 2025 Mar;16(3):360-369. doi: 10.1111/jdi.14394. Epub 2024 Dec 24.

  PMID: 39716905 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Yun Ye

CONTACT

0519-68870000; ntyeyun@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 15, 2026
• Study Start: December 24, 2025
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: April 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• 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.

Locations

CN (1)