A three-arm, parallel group, cluster randomized controlled trial to evaluate digital and complex lifestyle...

The Daqing Diabetes Prevention Study II (Daqing DPS-II) builds on the landmark study Daqing Diabetes Prevention Study to develop real-world implementation strategies for preventing type 2 diabetes (T2DM). This study aims to evaluate the effectiveness of digital and complex lifestyle intervention in reducing the incidence of T2DM among adults with increased risk of T2DM, compared to usual care over a 36-month period.

A three-arm, stratified, cluster-randomized controlled trial will be conducted in eight factories in Daqing, with clusters as the unit of randomization and individual participants as the unit of analysis. Fifty-seven clusters will be randomly allocated (1:1:1) to one of three groups: (1) Digital-based lifestyle intervention, (2) complex lifestyle intervention, or (3) usual care. Eligible participants will be adults aged 25-55 with increased risk of T2DM, defined by IFG, IGT, HbA1c 5.7-6.4%, and/or 1-h PG above 8.6 mmol/L, while not meeting the criteria for diabetes. Exclusion criteria include significant cardiovascular disease (CVD) within 6 months, impaired liver function, renal dysfunction, other significant medical or psychological conditions, or participation in similar studies. The interventions will run for 3 years. The primary outcomes are the 3-year cumulative incidence of T2DM. The study will utilize the RE-AIM framework and Implementation Outcome Framework (IOF) to assess Reach, Adoption, Implementation, Maintenance, Feasibility, Acceptability, and Appropriateness through process measures. Data collection will include plasma glucose (0, 1, and 2 h) and insulin levels (0, 1, and 2 h) based on the oral glucose tolerance test, laboratory tests, blood pressure, body mass index, waist circumference, and dietary and physical activity behaviors, diabetes knowledge, and quality of life. These measures will be assessed by trained doctors or nurses at baseline and at 6-,12-, 24-, and 36-month follow-ups.

The study will provide evidence on how population-level strategies of digital and complex lifestyle intervention can be implemented in real-world settings to prevent diabetes. If proven effective, these strategies could be integrated into Workplace Wellness Program in China and other countries to prevent diabetes and other noncommunicable diseases.

Chinese Clinical Trial Registry ChiCTR2400080790. Registered on 7th February 2024 TRIAL ACRONYM: Daqing DPS-II: Daqing Diabetes Prevention Study II.