Pilot RCT of a Chinese Medicine Diabetes Education Programme

August 6, 2026 updated by: HO Janice Yuen-Shan, The Hong Kong Polytechnic University

Development and Pilot Test of a Chinese Medicine Diabetes Education Program 中醫糖尿病個人管理教育方案建構及初步試驗

The goal of this clinical trial is to learn if a Chinese medicine diabetes education programme is feasible and acceptable, and to explore its preliminary effects on self-management, for adults with type 2 diabetes in Hong Kong. The main questions it aims to answer are:

  1. Is the Chinese medicine diabetes education programme feasible to deliver in a community setting (recruitment, retention and adherence)?
  2. Is the programme acceptable to participants?
  3. Does the programme show early signals of improving diabetes management self-efficacy and related outcomes?

Researchers will compare the Chinese medicine education programme to usual care to see if the programme is feasible, acceptable and shows preliminary benefits.

Participants will:

  1. Be randomly assigned to either a 4-week Chinese medicine diabetes education programme (four group sessions, total 4-6 hours) or usual care
  2. Complete assessments at baseline, after the programme, and at 2-month follow-up.
  3. Attend a focus group interview at the end of the study (selected participants)

Outcome assessors will be blinded to group allocation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pilot randomised controlled trial evaluates the feasibility, acceptability and preliminary effects of a Chinese medicine diabetes education programme for adults with type 2 diabetes in Hong Kong.

While Western-medicine-based diabetes education is well established locally, systematic and interactive Chinese medicine education remains limited. The programme integrates Chinese medicine concepts (body constitution, pattern differentiation, dietary therapy, emotional regulation, acupressure and lifestyle advice) with modern self-management principles. Content was refined through literature review, patient input and Delphi consensus.

Forty adults with type 2 diabetes will be randomly allocated (1:1) to either a 4-week group education programme (four sessions, total 4-6 hours) or usual care. The control group will be offered the programme after final follow-up. Participants and facilitators are not blinded due to the nature of the educational intervention; outcome assessors will remain blinded to group allocation.

Primary aims are to assess feasibility (recruitment, retention, adherence) and acceptability. Exploratory outcomes, measured at baseline, post-intervention and 2-month follow-up, include diabetes management self-efficacy (Chinese version of the Diabetes Management Self-Efficacy Scale, C-DMSES; Wu et al., 2008), self-management behaviours, blood glucose, lipids, BMI and blood pressure. Focus group interviews will gather qualitative feedback.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or above
  • Diagnosed with type 2 diabetes mellitus
  • Able to understand and communicate in Cantonese, and able to read Chinese
  • Willing and able to provide written informed consent
  • Able to attend the education sessions at the designated venues

Exclusion Criteria:

  • Severe cognitive impairment that would prevent meaningful participation in group education
  • Acute or unstable medical conditions, or serious chronic illnesses currently under active treatment (e.g., ongoing cancer treatment), that may preclude safe participation in group activities
  • Currently participating in another structured diabetes education research programme
  • Pregnancy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
Participants will continue their usual medical care and any existing diabetes education or support. No additional structured Chinese medicine diabetes education programme will be provided during the study. After the final follow-up, they will be offered the same education programme.
Experimental: Chinese Medicine Diabetes Education Programme
Participants will receive a 4-week Chinese medicine diabetes education programme consisting of four weekly group sessions (total 4-6 hours). Content includes Chinese medicine concepts of diabetes, body constitution, diet, emotional regulation, acupressure, skin and foot care, and physical activity.
Behavioral: Chinese Medicine Diabetes Education Programme
A structured 4-week group education programme (four sessions, total contact time 4-6 hours) that integrates Chinese medicine concepts (body constitution, pattern differentiation, dietary therapy, emotional regulation, acupressure, and lifestyle advice) with modern diabetes self-management education.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: From start of recruitment to end of recruitment period
Proportion of eligible individuals who provide informed consent and are randomised into the study.
From start of recruitment to end of recruitment period
Retention rate
Time Frame: From randomisation to 2-month follow-up
Proportion of randomised participants who complete the post-intervention assessment (T1) and the 2-month follow-up assessment (T2).
From randomisation to 2-month follow-up
Adherence to the education programme
Time Frame: During the 4-week intervention period
Proportion of participants in the intervention group who attend at least 3 out of the 4 scheduled education sessions.
During the 4-week intervention period
Acceptability of the programme
Time Frame: At the end of the 4-week education programme
Participant-reported acceptability and satisfaction with the Chinese medicine diabetes education programme, assessed by a structured questionnaire at the end of the programme. Additional qualitative feedback will be collected through focus group interviews at 2-month follow-up.
At the end of the 4-week education programme

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Diabetes management self-efficacy
Time Frame: Baseline, post-intervention (T1), and 2-month follow-up (T2)
Measured by the Chinese version of the Diabetes Management Self-Efficacy Scale (C-DMSES).
Baseline, post-intervention (T1), and 2-month follow-up (T2)
Diabetes self-management behaviours
Time Frame: Baseline, post-intervention (T1), and 2-month follow-up (T2)
Self-reported diabetes self-management behaviours, assessed using a participant logbook recording the frequency of exercise, acupressure, blood glucose monitoring and other self-care activities.
Baseline, post-intervention (T1), and 2-month follow-up (T2)
Blood glucose level
Time Frame: Baseline and 2-month follow-up (T2)
Fasting blood glucose level, HbA1c
Baseline and 2-month follow-up (T2)
Blood lipid levels
Time Frame: Baseline and 2-month follow-up (T2)
Total cholesterol, triglycerides, HDL-C and LDL-C
Baseline and 2-month follow-up (T2)
Body mass index (BMI)
Time Frame: Baseline, post-intervention (T1), and 2-month follow-up (T2)
Calculated from measured height and weight.
Baseline, post-intervention (T1), and 2-month follow-up (T2)
Blood pressure
Time Frame: Baseline, post-intervention (T1), and 2-month follow-up (T2)
Systolic and diastolic blood pressure.
Baseline, post-intervention (T1), and 2-month follow-up (T2)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yuen-Shan Ho, PhD, The Hong Kong Polytechnic 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P0046606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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