A family based trial for primary prevention of type 2 Diabetes in South Asians

Lead Research Organisation: University of Edinburgh
Department Name: Centre of Population Health Sciences

Abstract

Lay summary:Type 2 diabetes is a serious disease. It runs in families, but is mainly caused by being overweight and not being physically active. About 20% of British South Asians have diabetes, compared to 4% of the UK population. Weight loss and exercise programmes prevent diabetes internationally but this has not been proven, either in the UK or in UK South Asians. This research will investigate whether a family-based lifestyle change programme (based on diet and physical activity) will prevent diabetes in people living in families where there is diabetes. This will benefit the population by helping us understand how to prevent diabetes.

Wider issues: The Universities involved are active in public engagement in science. The PI (Bhopal) will take primary responsibility for ensuring dissemination of the results via the popular media, through press releases, and interviews with radio and television. Bhopal has a track record of such work. Our links with the community and professionals are excellent, and several of the investigators and collaborators will work to ensure policy makers, practitioners, and the public are directly engaged during the dissemination process.

Technical Summary

Central obesity, a sedentary lifestyle, impaired glucose tolerance (IGT) and diabetes are highly prevalent in South Asians. Diabetes is preventable through weight loss and increasing physical activity but this has not been demonstrated either in the UK or for South Asians. This trial evaluates an intervention within the family of people with diabetes but designed to reduce weight and increase physical activity in their adult relatives at high risk of diabetes indicated by IGT, thereby preventing or delaying diabetes. The interventions will be those used internationally, but adapted for South Asians. 300 families will be randomised into intervention and control groups, each containing two people with IGT (600 people in total).The intervention group of 300 will receive 15 contacts with a trained dietician over three years, with the goal of reducing weight, achieving at least 30 minutes of physical activity daily, and making measurements. The control group of 300 will have 4 contacts with a dietician to provide health information and make measurements. The primary outcome is progression from IGT to diabetes, based on the oral glucose tolerance test (OGTT). The intervention is anticipated to reduce the 3-year incidence of diabetes from 30 percent to 15 percent. Cost effectiveness of the intervention will be calculated. Qualitative research will help in implementing the trial.

Publications

10 25 50

 
Description NHS Health Scotland strategy
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Participation in advisory committee
 
Description NICE guideline
Geographic Reach National 
Policy Influence Type Membership of a guidance committee
 
Description Scottish Diabetes Plan
Geographic Reach Local/Municipal/Regional 
Policy Influence Type Participation in advisory committee
 
Description NPRI supplementary funding
Amount £177,878 (GBP)
Organisation Medical Research Council (MRC) 
Department National Prevention Research Initiative (NPRI)
Sector Charity/Non Profit
Country United Kingdom
Start 09/2011 
End 03/2013
 
Description Collaboration with colleagues in the Netherlands 
Organisation University of Amsterdam
Department Institute of Social Medicine
Country Netherlands 
Sector Academic/University 
PI Contribution Working with colleagues in the Netherlands to compare recruitment methods for PODOSA and DHIANN (diabetes prevention study in The Hague, Netherlands). In addition a meta-analysis of overall trial data has been carried out by University of Amsterdam which includes data from PODOSA.
Collaborator Contribution Colleagues from the Netherlands are leading on initial joint analysis of recruitment and outcome data for diabetes prevention trials in South Asians.
Impact A meta-analysis of overall trial data has been completed including the PODOSA trial data (anonymised individual level data transferred under a Data Transfer Agreement). A paper entitled 'Effects of dietary and physical activity interventions to reduce the risk of type 2 diabetes in South Asians worldwide: meta-analysis of individual participant data from randomized controlled trials' is in preparation (February 2018). Collaboration is multi-disciplinary including diabetes clinicians, academic researchers and statisticians.
Start Year 2007
 
Description meta-analysis collaboration 
Organisation Academic Medical Center
Country Netherlands 
Sector Academic/University 
PI Contribution Initiate a meeting between international colleagues to harmonise the different diabetes prevention study protocols to allow future meta-anaylses
Collaborator Contribution Strengthened the case for continuing the PODOSA study to allow 3 years of intervention so that meta analyses will be possible.
Impact the collaboration will allow significant meta-analyses of the PODOSA data along with other diabetes prevention studies being carried out inother countries in South Asian populations.
Start Year 2007
 
Title PODOSA Intervention Manual 
Description The PODOSA intervention manual describes in detail the methods and resources used to carry out the trial intervention in the South Asian population. The intention is to distribute for free use for further academic research or use in the health service.The Investigators will consider permission for any commercial use. 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Refinement. Non-clinical
Year Development Stage Completed 2012
Development Status Closed
Clinical Trial? Yes
Impact The manual will contribute to the evidence base for culturally adapted interventions in prevention of diabetes in South Asians in the UK. 
URL http://www.podosa.org/PODOSA%20Intervention%20manual%20January2013.pdf
 
Title PODOSA Standard Operating Procedures 
Description The purpose of this Standard Operating Procedure (SOP) is to ensure accurate, repeatable measurements. The manual describes in detail the methods used to carry out the trial intervention in the South Asian population. 
Type Preventative Intervention - Behavioural risk modification
Current Stage Of Development Refinement. Non-clinical
Year Development Stage Completed 2012
Development Status Closed
Impact The manual will contribute to the evidence base for culturally adapted interventions in prevention of diabetes in South Asians in the UK. 
URL http://www.podosa.org/PODOSA%20SOPs%20for%20website%20020913.pdf
 
Description Diabetes UK Professional Conference - March 2013 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Type Of Presentation Poster Presentation
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Presented initial trial results at Diabetes UK Professional Conference, March 2013.

Initial trial results presented.
Year(s) Of Engagement Activity 2013
 
Description Diabetes groups talks 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Paper Presentation
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact Oral presentations on PODOSA at various meetings of diabetes professionals such as the Scottish Diabetes Group, Diabetes management & education group and local MCN meetings.

Awareness raising
Year(s) Of Engagement Activity 2006,2007,2008
 
Description Migrant and ethnic health research conference 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presentation of the final results of the PODOSA trial to a new audience. Provided discussion for further research.
Year(s) Of Engagement Activity 2015
 
Description NHS/Diabetes articles 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Health professionals
Results and Impact Articles written for NHS Lothian and Greater Glasgow & Clyde publications and for Diabetes Lifestyle

Awareness raising for PODOSA trial
Year(s) Of Engagement Activity 2007,2008
 
Description Radio interviews 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Radio interviews involving 2 members of the PODOSA team - about PODOSA study.

Awareness raising
Year(s) Of Engagement Activity 2008,2009
 
Description South Asian Community Organisation Meetings 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Type Of Presentation Keynote/Invited Speaker
Geographic Reach Local
Primary Audience Public/other audiences
Results and Impact Participant and South Asian community organisations meetings in Edinburgh and Glasgow to disseminate trial results.

Disseminated trial results to trial participants and other interested parties.
Year(s) Of Engagement Activity 2007,2008,2009,2010,2011