NCT Number: NCT07758413
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
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.
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).
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.
Time frame: Baseline and 2-month follow-up (T2)
Fasting blood glucose level, HbA1c
Time frame: Baseline and 2-month follow-up (T2)
Total cholesterol, triglycerides, HDL-C and LDL-C
Time frame: Baseline, post-intervention (T1), and 2-month follow-up (T2)
Calculated from measured height and weight.
Time frame: Baseline, post-intervention (T1), and 2-month follow-up (T2)
Systolic and diastolic blood pressure.
Contact information is provided by the study sponsor or research team.
The Hong Kong Polytechnic University
Other
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
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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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