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Completed

NCT Number: NCT07524166

Empowerment-Based Health Education and Type 2 Diabetes Mellitus

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

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Key information

Conditions

Diabetes Diabete Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jiaxing University

Jiaxing, Zhejiang, 314001, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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 .

  2. 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

Secondary outcomes

  1. Diabetes-specific knowledge

    Time frame: From enrollment to the end of treatment at 6 weeks

    Score of Diabetes Knowledge Test (DKT).

  2. Self-efficacy

    Time frame: From enrollment to the end of treatment at 6 weeks

    Score of Diabetes Management Self-Efficacy Scale (DMSES).

  3. diabetes self-management behaviors

    Time frame: From enrollment to the end of treatment at 6 weeks

    Score of Diabetes Self-Care Activities (SDSCA) measure.

Sponsors and collaborators

Lead sponsor

Eotvos Lorand University

Other

Collaborators

  • Jiaxing University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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