Optimizing Implementation of the Intensive Diabetes Prevention Program
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Standard IDPP
BehavioralParticipants 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
BehavioralThe 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.
Treatment groups
170 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Recruitment rate will be defined as the proportion of eligible individuals at participating DHCs who are successfully recruited into the study.
Time frame
One year2
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.
Time frame
One year3
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.
Time frame
One year4
Participant adherence
Participant adherence will be measured using attendance records from nurse consultations and group workshops.
Time frame
One yearSecondary outcomes
1
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.
Time frame
Baseline, six months, one year, 1.5 years2
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.
Time frame
Baseline, six months, one year, 1.5 years3
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).
Time frame
Baseline, six months, one year, 1.5 years4
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).
Time frame
Baseline, six months, one year, 1.5 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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