Optimizing Implementation of the Intensive Diabetes Prevention Program

NCT07412912 | Not Yet Recruiting

• 1 other identifier: AwongIDPP
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Intensive Diabetes Prevention Program; Behavioural determinants; Prediabetes management

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (7)

• Changes in HbA1c

  Baseline, six months, one year, 1.5 years

• Lipid profile

  Baseline, six months, one year, 1.5 years

• Weight

  Baseline, six months, one year, 1.5 years

• Height

  Baseline, six months, one year, 1.5 years

• Perceptions of empowerment

  Baseline, six months, one year, 1.5 years

Study Arms (2)

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.

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.

Behavioral: Optimized IDPP

Interventions

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.

Control group

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Arkers Wong, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arkers Wong, PhD

CONTACT

852 3400 3805; arkers.wong@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The research team staff and participants will be masked for the group allocation during the whole process.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blinded, two-armed, randomized controlled trial

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-02