Optimizing Implementation of the Intensive Diabetes Prevention Program

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?

Study Overview

• Status: Not yet recruiting
• Conditions: Prediabetes; Implementation Science; Diabetes Prevention
• Intervention / Treatment: Behavioral: Standard IDPP; Behavioral: Optimized IDPP

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arkers Wong, PhD; Phone Number: 852 3400 3805; Email: arkers.wong@polyu.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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; 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.
Experimental: Intervention group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: The Hong Kong Polytechnic University
• Investigators: Principal Investigator: Arkers Wong, PhD, The Hong Kong Polytechnic University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Prediabetes management; Intensive Diabetes Prevention Program; Behavioural determinants
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Prediabetic State
• Other Study ID Numbers: AwongIDPP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No