An interventional study of Standard IDPP and Optimized IDPP in Prediabetes, Diabetes Prevention and Implementation Science, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Health services research
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:
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's planned enrollment of 170 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Standard IDPP
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.
Behavioral: Optimized 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.
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.
Recruitment rate
Recruitment rate will be defined as the proportion of eligible individuals at participating DHCs who are successfully recruited into the study.
Time frame: 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.
Time frame: 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.
Time frame: One year
Participant adherence
Participant adherence will be measured using attendance records from nurse consultations and group workshops.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1.5 years
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.
Time frame: Baseline, six months, one year, 1.5 years
Lipid profile
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, six months, one year, 1.5 years
No study locations are listed for this record.
Start is estimated for Dec 2026; primary completion for Jun 2027, 5 months later.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's planned 5 months is below that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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