Prevention of Diabetes and Obesity in South Asians - linkage study
Research type
Research Study
Full title
Prevention of diabetes and Obesity in South Asians - linkage study
IRAS ID
219998
Contact name
Raj Bhopal
Contact email
Sponsor organisation
The University of Edinburgh
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
The PODOSA trial was a controlled, cluster, randomised trial designed to assess whether a family−based weight loss and physical activity programme, modelled on interventions of proven effectiveness internationally, could reduce the incidence of type 2 diabetes in South Asians. It also aimed to estimate the cost effectiveness of the intervention and use qualitative research to identify factors which can be used to assist recruitment, retention and adherence within the trial. This study was given ethical approval in 2007 (reference 07/MRE10/2).
Following difficulties with recruitment, the study primary outcome was amended in June 2009 from “reduction in the incidence of type 2 diabetes” to “weight change at 3 years”. In order for the research team to investigate whether the intervention has longer term effects on the risk of developing diabetes, the study team planned to link data from the PODOSA trial to NHS data on diabetes diagnoses held in the Scottish Care Information (SCI)- diabetes database, the national population based diabetes register. This linkage was included in the substantial amendment submitted to MREC Scotland B on 5 June 2009. All participants have given informed consent to have their study data linked to other NHS information (e.g. SMR data or the diabetes register).
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/0826
Date of REC Opinion
17 May 2017
REC opinion
Favourable Opinion