Diabetes Prevention, Implementation Science, Prediabetes
Conditions
Keywords
Intensive Diabetes Prevention Program, Behavioural determinants, Prediabetes management
Brief summary
The goal of this clinical trial is to explore the effectiveness and implementation outcomes of the optimized Intensive Diabetes Prevention Program (IDPP) in District Health Centres. The main questions it aims to answer are: * Do the implementation strategies - patient engagement system, structured training, and reminder systems - work better than usual approaches in terms of acceptability, adoption, appropriateness, feasibility, sustainability, and implementation cost? * Do patient health outcomes - HbA1c levels, BMI, lipid profile, quality of life, perception of empowerment, and health service utilization - stay the same or get better when these improved strategies are used compared to usual approaches?
Interventions
BEHAVIORALStandard IDPP
Participants in the control group will receive the standard IDPP as routinely delivered by the DHCs, without additional engagement or implementation strategies. This includes up to four optional group education sessions, two annual nurse-led consultations, and up to three individual counselling sessions per year.
BEHAVIORALOptimized IDPP
The optimized IDPP maintains the one-year IDPP structure while adding pre-implementation staff training, two enhanced nurse consultations, a structured reminder and follow-up system, and sustainment strategies.
Sponsors
The Hong Kong Polytechnic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The research team staff and participants will be masked for the group allocation during the whole process.
Intervention model description
Double-blinded, two-armed, randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being 18 years of age or above * Having a baseline HbA1c within the prediabetes range (6.0%-6.4%) * Holding a scheduled appointment at a DHC
Exclusion criteria
* Having a diagnosis of diabetes mellitus * Currently using of oral hypoglycaemic agents or medications known to induce significant weight changes * Having medical conditions that would limit participation, such as active cancer or cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | One year | Recruitment rate will be defined as the proportion of eligible individuals at participating DHCs who are successfully recruited into the study. |
| Retention rate | One year | Retention rate will be defined as the percentage of enrolled participants who complete both scheduled nurse-led consultations and attend at least two of the four group education sessions within the 12-month intervention period. |
| Acceptability | One year | Acceptability will be assessed through semi-structured focus group interviews with participants and providers after the implementation phase. Participants will share their satisfaction with key program components, and discuss perceived benefits and challenges. Providers will reflect on the practicality and relevance of the training sessions and enhanced workflows, and how these strategies affected their ability to deliver the IDPP effectively. |
| Participant adherence | One year | Participant adherence will be measured using attendance records from nurse consultations and group workshops. |
| Provider adherence | One year | Provider adherence will be assessed through meeting logs and fidelity checklists that capture consistent application of optimized protocols in clinical practice. |
| Appropriateness | One year | Appropriateness will be evaluated through semi-structured interviews with key stakeholders, including DHC managers, nurses, dietitians, physiotherapists, and participants. Interviews will explore how well the optimized implementation strategies fit within existing DHC workflows, address operational challenges, and support patient engagement. |
| Fidelity | One year | Fidelity, defined as the extent to which implementation strategies are delivered consistently and as intended, will be assessed using structured performance checklists completed by the PI during random audits of nurse consultations, along with reviews of audio-recorded sessions and provider self-reported logs. |
| Implementation cost | One year | Implementation cost will be assessed from an organizational perspective by capturing direct costs associated with delivering the optimized IDPP. Data will include staff time and operational expenses, with incremental cost-effectiveness analyses conducted alongside sensitivity analyses to test key cost assumptions; results will be presented using cost-effectiveness planes and bootstrapped confidence intervals. |
| Sustainability | 1.5 years | Sustainability will be evaluated by examining the extent to which optimized strategies remain embedded in routine DHC operations after external research support concludes. Focus groups with DHC managers and nurses at the end of the sustainment phase will explore long-term feasibility, while metrics will assess continued use of optimized workflows, provider adherence to protocols, and sustained patient engagement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HbA1c | Baseline, six months, one year, 1.5 years | Changes in HbA1c, which reflects average blood glucose levels over the previous 2-3 months, will be assessed from blood samples collected by DHC nurses. Results are typically in mg/dL. |
| Lipid profile | Baseline, six months, one year, 1.5 years | Lipid profile (including cholesterol level, high-density lipoprotein, and low-density lipoprotein) will be collected together with the HbA1c from the blood samples drawn by DHC nurses. Results are typically in mg/dL. |
| Weight | Baseline, six months, one year, 1.5 years | Weight will be measured in kilograms (kg), without shoes, and recorded to the nearest 0.1 kg. Body Mass Index (BMI) will be calculated using participants' weight (kg) divided by height (m²). |
| Height | Baseline, six months, one year, 1.5 years | Height will be measured in meters (m), without shoes, and recorded to the nearest 0.1 cm. Body Mass Index (BMI) will be calculated using participants' weight (kg) divided by height (m²). |
| Perceptions of empowerment | Baseline, six months, one year, 1.5 years | Perceptions of empowerment will be assessed using the Chinese version of the Patient Perceptions of Empowerment Scale (PPES). Its scores range from 11 to 55, with higher scores indicating higher perceived empowerment. |
| Quality of Life (QoL) | Baseline, six months, one year, 1.5 years | Quality of Life will be assessed using the Chinese version of the 12-item Short Form Health Survey version 2 (SF-12v2). Scores on the SF-12v2 range from 0 to 100, with higher scores indicating better quality of life. |
| Health service utilization | Baseline, six months, one year, 1.5 years | Health service utilization will be tracked by documenting unscheduled visits to general outpatient clinics, general practitioners, emergency departments, and hospitals over the six months preceding each assessment point. With participants' consent, utilization data will be obtained from the HA Go and eHRSS platforms and supplemented with self-reported information to ensure completeness. |
Contacts
CONTACTArkers Wong, PhD
PRINCIPAL_INVESTIGATORArkers Wong, PhD
The Hong Kong Polytechnic University
Outcome results
None listed