Pilot RCT of a Chinese Medicine Diabetes Education Programme

NCT07758413 | Not Yet Recruiting

• 1 other identifier: P0046606
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Is the Chinese medicine diabetes education programme feasible to deliver in a community setting (recruitment, retention and adherence)?
2. 2.Is the programme acceptable to participants?
3. 3.Does the programme show early signals of improving diabetes management self-efficacy and related outcomes?
4. 4.Be randomly assigned to either a 4-week Chinese medicine diabetes education programme (four group sessions, total 4-6 hours) or usual care
5. 5.Complete assessments at baseline, after the programme, and at 2-month follow-up.
6. 6.Attend a focus group interview at the end of the study (selected participants)

Conditions

Diabetes (DM); Medicine, Chinese Traditional

Keywords

Diabetes Mellitus; patient education; self-management; medicine, chinese traditional

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  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

  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

  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

  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 Outcomes (6)

• Diabetes management self-efficacy

  Baseline, post-intervention (T1), and 2-month follow-up (T2)

• Diabetes self-management behaviours

  Baseline, post-intervention (T1), and 2-month follow-up (T2)

• Blood glucose level

  Baseline and 2-month follow-up (T2)

• Blood lipid levels

  Baseline and 2-month follow-up (T2)

• Body mass index (BMI)

  Baseline, post-intervention (T1), and 2-month follow-up (T2)

Study Arms (2)

Usual Care

NO INTERVENTION

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.

Chinese Medicine Diabetes Education Programme

EXPERIMENTAL

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

Interventions

Chinese Medicine Diabetes Education Programme BEHAVIORAL

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.

Chinese Medicine Diabetes Education Programme

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• Yuen-Shan Ho, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuen-Shan Ho, PhD

CONTACT

852 2766 6410; janice.ys.ho@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share