Empowerment-Based Health Education and Type 2 Diabetes Mellitus

NCT07524166 | Completed

• 1 other identifier: Jiaxing University (YX-202501)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Empowerment-based education may offer a sustainable approach to type 2 diabetes management, yet rigorous evidence within the Chinese healthcare context was lacking.

Conditions

Diabetes; Diabete Mellitus; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Glycated hemoglobin (HbA1c)

  level of Glycated hemoglobin (HbA1c) , which aimed to reflect average blood glucose levels .

  From enrollment to the end of treatment at 6 weeks

• fasting plasma glucose (FPG)

  Lelel of Glycemic control, which reflects immediate glycemic status

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (3)

• Diabetes-specific knowledge

  From enrollment to the end of treatment at 6 weeks

• Self-efficacy

  From enrollment to the end of treatment at 6 weeks

• diabetes self-management behaviors

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

Empowerment-Based Health Education

Behavioral: Empowerment-Based Health Education

control group

NO INTERVENTION

regular care

Interventions

Empowerment-Based Health Education BEHAVIORAL

The program consisted of six weekly sessions, each lasting approximately 60-90 minutes, including 1) introducing introducing the empowerment philosophy; 2) enhancing diabetes knowledge and correct misconceptions through guided questioning and a "Myth Busters" group activity; 3) encouraging participants to reflect on their understanding of the disease; dietary management by teaching the food exchange method through hands-on activities with food models; 5) facilitating discussions on benefits and barriers to physical activity; teaching participants how to calculate appropriate exercise intensity; 6) sharing participants' personal progress and guiding them to develop individualized long-term self-management plans.

intervention group

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with T2DM according to clinical record;
• aged 40 years or older;
• duration of diabetes of at least 6 months;
• ability to communicate and complete questionnaires independently;
• provision of written informed consent.

You may not qualify if:

• presence of severe diabetes complications (e.g., renal failure, proliferative retinopathy, severe neuropathy);
• diagnosis with other major chronic illnesses (e.g., cancer, severe heart failure);
• pregnancy or lactation;
• participation in other interventional studies during the trial period;
• cognitive or psychiatric disorders that would impede participation.

Sponsors & Collaborators

• Eotvos Lorand University: lead
• Jiaxing University: collaborator

Study Sites (1)

Jiaxing University

Jiaxing, Zhejiang, 314001, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 13, 2026
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)