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NCT Number: NCT07412912

Optimizing Implementation of the Intensive Diabetes Prevention Program

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?

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Participant adherence

    Time frame: One year

    Participant adherence will be measured using attendance records from nurse consultations and group workshops.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. Changes in HbA1c

    Time frame: 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.

  2. Lipid profile

    Time frame: 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.

  3. Weight

    Time frame: 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).

  4. Height

    Time frame: 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).

  5. Perceptions of empowerment

    Time frame: 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.

  6. Quality of Life (QoL)

    Time frame: 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.

  7. Health service utilization

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Arkers Wong, PhD

CONTACT

[email protected]

852 3400 3805

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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