An interventional study of IDPP With optimized Implementation Strategies and Usual IDPP in Prediabetes / Type 2 Diabetes, sponsored by The Hong Kong Polytechnic University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Health services research
The IDPP provides lifestyle support for people with prediabetes at DHCs in Hong Kong . However, low recruitment and retention limit its impact. This study aims to improve recruitment and retention by examining the benefits of enhanced participant engagement, staff training, and structured reminders and follow-up compared with usual program delivery.
Objectives: The IDPP provides lifestyle support for people with prediabetes at DHCs in Hong Kong. However, low recruitment and retention limit its impact. This study aims to examine whether optimized implementation strategies improve recruitment and retention while maintaining or improving participants' health outcomes.
Hypotheses to be tested: Compared with usual program delivery. optimized implementation strategies will improve recruitment. retention, and other outcomes while maintaining the clinical outcomes.
Design and subjects: This is a implementation study using a two arms cluster randomized controlled trial. The study will recruit 170 adults aged 18 or above with prediabetes.
Instruments: Program records and structured checklists will assess participation and delivery of the implementation strategies. The Chinese Patient Perceptions of Empowerment Scale and the Chinese 12-item Short Form Health Survey version 2 will assess empowerment and quality of life. Interviews will explore participants' and staff members' experiences.
Intervention: The intervention group will receive the one-year IDPP with enhanced nurse consultations, staff training, appointment reminders, and follow-up after missed appointments. Nurse consultation will include personal goal-setting and shared decisions about lifestyle changes. The control group will receive the usual local IDPP services.
Main outcomes: The primary outcomes are recruitment and retention rates. Other implementation outcomes include acceptability, adoption and sustainability. Secondary health outcomes include blood sugar control, BMI, quality of life and empowerment.
Data analysis: Generalized estimating equations will examine changes in clinical outcomes over time and differences between groups. Recruitment and retention rates will be compared between groups. Interview will undergo thematic analysis.
Expected results: The optimized strategies are expected to help more people join and remain in the IDPP while maintaining or improving health outcomes. The findings will inform the delivery and long-term use of diabetes prevention services in community settings.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant will receive the one year IDPP with enhanced nurse consultations and follow-up.
Behavioral: IDPP With optimized Implementation Strategies
Participants will receive the one year IDPP according to existing DHC services.
Behavioral: Usual IDPP
The implementation includes an enhanced nurse consultations. Nurses will help participants understand prediabetes, set personal goals and review lifestyle changes. DHC staff will send reminders three days before scheduled consultations. Provider training and ongoing feedback will support program delivery.
The usual IDPP offers four voluntary group education sessions delivered by DHC staffs. There is also a nurse consultation at the DHC.
Recruitment and Retention rates
Feasibility (Primary outcome: Recruitment and Retention rates) Recruitment will be calculated as the proportion of eligible patients who agree to participate in the IDPP out of the total eligible population that reached the DHCs. Retention rate will be defined as the proportion of participants who complete both nurse consultation sessions and at least two of the four group-based educational sessions over a one-year period.
Time frame: 12 - month
Acceptability
Acceptability will be evaluated using semi-structured interviews with participants and providers following the implementation phase.
Time frame: 12 - month
Adoption
Adoption will assess the extent to which participants and providers engage with and adhere to the optimized IDPP strategies.
Time frame: 12 - month
Appropriateness
The perceived relevance and compatibility of the implementation strategies with participant needs, existing workflows, and center resources. Data will be collected through semi-structured interviews with participants and staff.
Time frame: 12-month
Fidelity
Fidelity, or the extent to which the implementation strategies are delivered as consistently and as intended
Time frame: 12 - month
Implementation cost
Implementation cost will be assessed from an organizational perspective, capturing direct cost associated with delivering the optimized IDPP. Data will be collected through tracking staff time and operational expenses, and by conducting analysis of incremental cost-effectiveness.
Time frame: 12 m- month
Sustainability
Sustainability will be assessed as the extent to which the optimized strategies remain integrated into routine DHC operations after external research support ends.
Time frame: 12 - month
HbA1c
Mean change in HbA1c level will be measured from blood samples drawn by DHC nurses and analyzed to reflect average blood glucose levels over the previous 2-3months.
Time frame: Baseline, 6-month, 12-month, 18-month
BMI
Change from baseline in BMI, calculated as weight in kilograms divided by height in meters squared.
Time frame: Baseline, 6-month, 12-month, 18-month
Lipid profile
Lipid profile ( including cholesterol level, high-density lipoprotein, and low-density lipoprotein) will be collected by DHC nurses.
Time frame: Baseline, 6-month, 12-month, 18-month
Perceptions of empowerment
Perceptions of empowerment will be measured using the Chinese version of the Patient Perceptions of Empowerment Scale (PPES) , an 11-item validated tool with a content validity index of 0.93. The PPES evaluates empowerment across four domains: information (three items), decision-making (two items), individualized autonomy (three items), and staff-management (three items). This tool has proven reliable for assessing empowerment in clinical and research settings.
Time frame: Baseline, 6-month, 12-month, 18-month
Quality of life
QoL will be assessed using the Chinese version of the 12-item Short Form Health Survey version 2 (SF-12), which has demonstrated reliability in local populations.
Time frame: Baseline, 6-month, 12-month, 18-month
Health services utilization
Health services utilizations will be assessed by tracking unscheduled visits to general outpatient departments, general practitioners, emergency departments, and hospitals during the six months preceding each data collection timepoint.
Time frame: Baseline, 6-month, 12-month, 18-month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2028, 18 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 18 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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