DiabetesNCT07524166
Empowerment-Based Health Education and Type 2 Diabetes Mellitus
A study testing Empowerment-Based Health Education in people with Diabetes and Diabete Mellitus, run by Eotvos Lorand University at 1 site in China.
Trial summary
Empowerment-based education may offer a sustainable approach to type 2 diabetes management, yet rigorous evidence within the Chinese healthcare context was lacking. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabete Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- Empowerment-Based Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes, Diabete Mellitus, Diabetes Mellitus, Type 2
- Being tested
- Empowerment-Based Health Education
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment-Based Health EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Empowerment-Based Health Education Receives: Behavioral: Empowerment-Based Health Education |
| control group | No intervention | regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin (HbA1c)
level of Glycated hemoglobin (HbA1c) , which aimed to reflect average blood glucose levels .
Measured: From enrollment to the end of treatment at 6 weeks
fasting plasma glucose (FPG)
Lelel of Glycemic control, which reflects immediate glycemic status
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (3)
Diabetes-specific knowledge
Score of Diabetes Knowledge Test (DKT).
Measured: From enrollment to the end of treatment at 6 weeks
Self-efficacy
Score of Diabetes Management Self-Efficacy Scale (DMSES).
Measured: From enrollment to the end of treatment at 6 weeks
diabetes self-management behaviors
Score of Diabetes Self-Care Activities (SDSCA) measure.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Aug 2025
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eotvos Lorand University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiaxing University
- Responsible party
- Principal investigator, Feifei Wang, Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524166
- Sponsor's protocol ID
- Jiaxing University (YX-202501)
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Empowerment-Based Health Education on Self-Management in Patients With Type 2 Diabetes Mellitus: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07524166
- Acronym / sponsor ID
- Jiaxing University (YX-202501)
- Conditions
- Diabetes, Diabete Mellitus, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eotvos Lorand UniversityUniversity, hospital or other
- Collaborators
- Jiaxing University
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Empowerment-based education may offer a sustainable approach to type 2 diabetes management, yet rigorous evidence within the Chinese healthcare context was lacking.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Empowerment-Based Health EducationEmpowerment-Based Health Education |
| control group | No intervention | –regular care |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment-Based Health EducationThe 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. | Behavioural | intervention group |
Primary outcome
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 .
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
3 secondary outcomes
Diabetes-specific knowledge
Time frame: From enrollment to the end of treatment at 6 weeks
Self-efficacy
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment-Based Health Education in people with Diabetes and Diabete Mellitus, run by Eotvos Lorand University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (HbA1c) (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.