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Not yet recruiting NCT07412912

Optimizing Implementation of the Intensive Diabetes Prevention Program

No phase Interventional Prediabetes Diabetes Prevention Implementation Science

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard IDPP, Optimized IDPP.
Who it may be relevant to
Registry conditions: Prediabetes, Diabetes Prevention, Implementation Science. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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?

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Recruitment rate [Time frame: One year]
  • Retention rate [Time frame: One year]
  • Acceptability [Time frame: One year]
  • Participant adherence [Time frame: One year]
  • Provider adherence [Time frame: One year]
  • Appropriateness [Time frame: One year]
  • Fidelity [Time frame: One year]
  • Implementation cost [Time frame: One year]
  • Sustainability [Time frame: 1.5 years]
Secondary outcome measures (7)
  • Changes in HbA1c [Time frame: Baseline, six months, one year, 1.5 years]
  • Lipid profile [Time frame: Baseline, six months, one year, 1.5 years]
  • Weight [Time frame: Baseline, six months, one year, 1.5 years]
  • Height [Time frame: Baseline, six months, one year, 1.5 years]
  • Perceptions of empowerment [Time frame: Baseline, six months, one year, 1.5 years]
  • Quality of Life (QoL) [Time frame: Baseline, six months, one year, 1.5 years]
  • Health service utilization [Time frame: Baseline, six months, one year, 1.5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07412912 · AwongIDPP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗