Empowerment-Based Health Education and Type 2 Diabetes Mellitus

April 6, 2026 updated by: Feifei Wang, Eotvos Lorand University

The Impact of Empowerment-Based Health Education on Self-Management in Patients With Type 2 Diabetes Mellitus: A Randomized Control Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Jiaxing, Zhejiang, China, 314001
        • Jiaxing University

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

Yes

Description

Inclusion Criteria:

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

Exclusion criteria:

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

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Empowerment-Based Health Education
Behavioral: Empowerment-Based Health Education
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.
No Intervention: control group
regular care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (HbA1c)
Time Frame: From enrollment to the end of treatment at 6 weeks
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)
Time Frame: From enrollment to the end of treatment at 6 weeks
Lelel of Glycemic control, which reflects immediate glycemic status
From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes-specific knowledge
Time Frame: From enrollment to the end of treatment at 6 weeks
Score of Diabetes Knowledge Test (DKT).
From enrollment to the end of treatment at 6 weeks
Self-efficacy
Time Frame: From enrollment to the end of treatment at 6 weeks
Score of Diabetes Management Self-Efficacy Scale (DMSES).
From enrollment to the end of treatment at 6 weeks
diabetes self-management behaviors
Time Frame: From enrollment to the end of treatment at 6 weeks
Score of Diabetes Self-Care Activities (SDSCA) measure.
From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

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

Sponsor

Eotvos Lorand University

Collaborators

Jiaxing University

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)

August 1, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jiaxing University (YX-202501)

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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