PrediabetesNCT07412912
Optimizing Implementation of the Intensive Diabetes Prevention Program
A study testing Standard IDPP and Optimized IDPP in people with Prediabetes and Diabetes Prevention, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes, Diabetes Prevention, Implementation Science
- What is being tested?
- Standard IDPP and Optimized IDPP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 2 Dec 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimizing Implementation of the Intensive Diabetes Prevention Program in District Health Centres: A Hybrid Type 3 Study to Enhance Recruitment and Retention for Prediabetes Management
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?
- Conditions
- Prediabetes, Diabetes Prevention, Implementation Science
- Being tested
- Standard IDPP, Optimized IDPP
- Keywords
- Intensive Diabetes Prevention Program, Behavioural determinants, Prediabetes management
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard IDPPBehavioural
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.
Optimized IDPPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Standard IDPP |
| 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. Receives: Behavioral: Optimized IDPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Recruitment rate will be defined as the proportion of eligible individuals at participating DHCs who are successfully recruited into the study.
Measured: 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.
Measured: 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.
Measured: One year
Participant adherence
Participant adherence will be measured using attendance records from nurse consultations and group workshops.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1.5 years
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, six months, one year, 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start2 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, two-armed, randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arkers, Wong, The Hong Kong Polytechnic University
- Investigators
- Arkers Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412912
- Sponsor's protocol ID
- AwongIDPP
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Implementation of the Intensive Diabetes Prevention Program in District Health Centres: A Hybrid Type 3 Study to Enhance Recruitment and Retention for Prediabetes Management
- ClinicalTrials.gov ID
- NCT07412912
- Acronym / sponsor ID
- AwongIDPP
- Conditions
- Prediabetes, Diabetes Prevention, Implementation Science
- Keywords
- Intensive Diabetes Prevention Program, Behavioural determinants, Prediabetes management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 2 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, two-armed, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Standard IDPPParticipants 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. |
| Intervention group | Experimental | Behavioral: Optimized IDPPThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard IDPPParticipants 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. | Behavioural | Control group |
| Optimized IDPPThe 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. | Behavioural | Intervention group |
Primary outcome
Recruitment rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: One year
Participant adherence will be measured using attendance records from nurse consultations and group workshops.
Provider adherence
Time frame: One year
Provider adherence will be assessed through meeting logs and fidelity checklists that capture consistent application of optimized protocols in clinical practice.
Appropriateness
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Changes in HbA1c
Time frame: Baseline, six months, one year, 1.5 years
Lipid profile
Time frame: Baseline, six months, one year, 1.5 years
Weight
Time frame: Baseline, six months, one year, 1.5 years
Height
Time frame: Baseline, six months, one year, 1.5 years
Perceptions of empowerment
Time frame: Baseline, six months, one year, 1.5 years
Quality of Life (QoL)
Time frame: Baseline, six months, one year, 1.5 years
Health service utilization
Time frame: Baseline, six months, one year, 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arkers Wong, PhD principal investigator
The Hong Kong Polytechnic University
Questions about this trial
What is this clinical trial studying?
A study testing Standard IDPP and Optimized IDPP in people with Prediabetes and Diabetes Prevention, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arkers Wong, PhD (852 3400 3805, arkers.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: One year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.