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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 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. |
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| Intervention group | Experimental | The intervention group will follow the same one-year IDPP structure as the control group, but will experience a series of optimized implementation strategies including adding pre-implementation staff training, two enhanced nurse consultations, a structured reminder and follow-up system, and sustainment strategies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard IDPP | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Recruitment rate will be defined as the proportion of eligible individuals at participating DHCs who are successfully recruited into the study. | One year |
| Retention rate | 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. | One year |
| Acceptability | 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. | One year |
| Participant adherence | Participant adherence will be measured using attendance records from nurse consultations and group workshops. | One year |
| Provider adherence | Provider adherence will be assessed through meeting logs and fidelity checklists that capture consistent application of optimized protocols in clinical practice. | One year |
| Appropriateness | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HbA1c | 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. | Baseline, six months, one year, 1.5 years |
| Lipid profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arkers Wong, PhD | Contact | 852 3400 3805 | arkers.wong@polyu.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Arkers Wong, PhD | The Hong Kong Polytechnic University | Principal Investigator |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Double-blinded, two-armed, randomized controlled trial
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The research team staff and participants will be masked for the group allocation during the whole process.
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| Optimized IDPP | Behavioral | 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. |
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| One year |
| Fidelity | 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. | One year |
| Implementation cost | 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. | One year |
| Sustainability | 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. | 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. |
| Baseline, six months, one year, 1.5 years |
| Weight | 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). | Baseline, six months, one year, 1.5 years |
| Height | 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). | Baseline, six months, one year, 1.5 years |
| Perceptions of empowerment | 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. | Baseline, six months, one year, 1.5 years |
| Quality of Life (QoL) | 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. | Baseline, six months, one year, 1.5 years |
| Health service utilization | 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. | Baseline, six months, one year, 1.5 years |
| D004700 | Endocrine System Diseases |