Not yet recruitingNCT07930195ClinicalTrials.gov record

Improving the Recruitment and Retention in the Intensive Diabetes Prevention Program at Hong Kong in District Health Centers

Prediabetes / Type 2 Diabetes

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 170 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the 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.

Read the full description

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

1. Aged 18 years or older
2. A baseline HbA1c level of 6.0% to 6.4%
3. An existing appointment for services provided by a DHC

Exclusion Criteria:

1. A diagnosis of diabetes mellitus
2. Current use of oral hypoglycemic agents or medications known to cause significant weight changes
3. Coexisting conditions that prevent participation, such as active malignancy or cognitive impairment

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Double masked

IDPP With Optimized Implementation Strategies

Participant will receive the one year IDPP with enhanced nurse consultations and follow-up.

Behavioral: IDPP With optimized Implementation Strategies

Usual IDPP

Participants will receive the one year IDPP according to existing DHC services.

Behavioral: Usual IDPP

IDPP With optimized Implementation Strategies BEHAVIORAL

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.

Usual IDPP BEHAVIORAL

The usual IDPP offers four voluntary group education sessions delivered by DHC staffs. There is also a nurse consultation at the DHC.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Recruitment and Retention rates

Time frame: 12 - month

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.

Secondary measures

Acceptability

Time frame: 12 - month

Acceptability will be evaluated using semi-structured interviews with participants and providers following the implementation phase.

Adoption

Time frame: 12 - month

Adoption will assess the extent to which participants and providers engage with and adhere to the optimized IDPP strategies.

Appropriateness

Time frame: 12-month

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.

Fidelity

Time frame: 12 - month

Fidelity, or the extent to which the implementation strategies are delivered as consistently and as intended

Implementation cost

Time frame: 12 m- month

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.

Sustainability

Time frame: 12 - month

Sustainability will be assessed as the extent to which the optimized strategies remain integrated into routine DHC operations after external research support ends.

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