Periodic Reporting for period 4 - iHealth-T2D (Family-based intervention to improve healthy lifestyle and prevent Type 2 Diabetes amongst South Asians with central obesity and prediabetes)
Période du rapport: 2019-01-01 au 2019-12-31
- Training and Piloting: study dieticians, CHW and supporting staff received intensive training which were organised in the 4 countries and delivered by each country’s dietician with the support of UK’s dietician. Additionally, screening, recruitment and clinic visits were piloted in all 4 countries, which allowed to identify and resolve potential problems and facilitated training of the staff involved in the study.
- Field work sites selection: The 120 field-work sites (30 in each country) were identified in 2015.
- Study database: A database has been custom written for storage and reporting on clinical data at a local level.
- Regulatory approval: Regulatory approval was obtained in all recruitment institutions between March and May 2016.
- Screening, enrolment and intervention: All sites achieved a total of 25,453 screened people, of whom 4,263 meet study entry criteria and are eligible for the study intervention. Of these, 3,670 were recruited into the intervention phase of the study (mean 30 people per site). These figures are in line with expectations in the project proposal.
- Intervention was successfully delivered to participants. Attendance rates were in line with expectations, and published experience.
- Follow-up: Index cases and their relatives were invited to attend follow-up annually after enrolment to the study. Follow-up year 1 was concluded in October 2018. Preliminary analyses by the trial statistical team suggest that the incidence of diabetes is in line with expectation, and that sample size remains appropriate. Final follow-up (Year 3) is expected to be completed in October 2020.
- Analysis: the statistical analysis plan has been finalised and submitted for publication. Analysis of the primary outcome (diabetes) will be carried out after Year 3 data are available. Preliminary analyses of clinical-effectiveness for secondary endpoints have been carried out using data from year 1 of follow-up. Costs effectiveness analyses have quantified the costs of screening, and have modelled the cost-effectiveness for intervention under a range of assumptions for outcomes.