How to strengthen the global evidence base for effective prevention of diabetes and its complications?

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1 How to strengthen the global evidence base for effective prevention of diabetes and its complications? Brian Oldenburg Professor of International Public Health Monash University AUSTRALIA

2 Diabetes is the fourth leading cause of disease-related death Over 285 million people worldwide are affected by type 2 diabetes (T2DM) and this is estimated to increase to 438 million by Over 70% of people with T2DM live in developing countries but 80% of the world s diabetes care-related expenditure occurs in developed countries.

3 1. To develop programs that are more feasible for real world implementation 2. To extend the global reach of programs, particularly to resource poor countries, where the burden is substantial How to do this?

4 5. Transfer to LMICs? Development of Kerala Diabetes Prevention Program 1. Diabetes Prevention Study (DPS in Finland) 2. GOAL program (Finland) 3. Diabetes Prevention Program (DPP in Australia) 4. Scaling up in Finland and Australia

5 1. Diabetes Prevention Study (DPS in Finland)

6 Evidence for lifestyle change in prevention efficacy trials The Finnish Diabetes Prevention Study (DPS, 2001): Lifestyle modification prevents type 2 diabetes 58% lower risk of diabetes US DPP and some other prevention trials (2002) : Lifestyle modification even more effective than drug treatment in preventing type 2 diabetes

7 DPS Main findings High-risk subjects (IGT) Experimental group with intensive counselling had a 58% lower risk in follow-up (mean 3.2 yrs) than control group Attainment of intervention objectives Less than 30%E from fat 47% Less than 10%E from saturated fat 26% At least 15g/1,000 kcal of fiber 25% At least 30 min/day physical activity 86% At least 5% weight reduction 43% 49/265 (18.5 %) None of those reaching 4-5 goals got T2D during the six-year follow-up *Tuomilehto, J., et al. (2001). Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. New England Journal of Medicine, 344,

8 Finnish DPS Challenges for replication? Resource-intensive: Individual counselling by licensed dieticians 3-year program Median number of appointments 20 20% of participants assigned to VLC-diet Free access to gym and personal training program Unrealistic for implementation in the primary health care setting What factors accounted for the success? Who were the ones to benefit?

9 4. Scaling up in Finland and Australia 1. Diabetes Prevention Study (DPS in Finland) efficacy trial 2. GOAL program a real world implementation trial in Finland 3. Diabetes Prevention Program (DPP in Australia)

10 2. GOAL Program for Good Ageing

11 Where??

12 GOAL Lifestyle Implementation Trial To implement the DPS findings in primary health care setting Aiming to change preventive practices and to provide tools for professionals Looking more in-depth at the lifestyle change process 6 x 2-hour task-oriented group education and lifestyle counselling sessions over 8 months (sociobehavioural intervention)

13 GOAL Implementation Trial: Summary of findings Outcomes at year 1: Diet objectives well attained (saturated fat 34%, total fat 48%, fibre 52%) Physical activity less than benchmark (66% vs. 86%) Weight loss modest, 12% achieved 5%, mean weight loss -0.8 kg (±4.5) Normal glucose tolerance more likely among those with 4-5 objectives attained Outcomes at year 3: Weight reduction at year 1 maintained at year 3: mean weight loss -1.0 kg (±5.6) Participants with baseline IGT at year three: 12% had converted to diabetes 43% had returned to normal Absetz, P., Valve, R., Oldenburg, B., et al. Type 2 diabetes prevention in the real world : One-year results of the GOAL implementation trial. Diabetes Care 30, , Absetz, P., Oldenburg, B., Hankonen, N., et al. Type 2 diabetes prevention in the real world : Three-year results of the GOAL implementation trial. Diabetes Care, 2009; 32 (8): /05/2011 Absetz /

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16 1. Diabetes Prevention Study (DPS in Finland) 2. GOAL program (Finland) 3. Diabetes Prevention Program (DPP in Australia) a real world implementation trial in Australia 4. Scaling up in Finland and Australia

17 3. Diabetes Prevention Program (DPP in Australia)

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19 Diabetes Prevention Program (DPP)(Australia) Adapted from GOAL Program Setting: Greater Green Triangle region of rural Australia Participants: 343 at risk individuals Recruited in General Practice reception areas FINDRISK risk score 12 Intervention: six 90 minute task-oriented group sessions over eight months Theories: Health Action Process Approach (HAPA), selfregulation theory, social learning theory, trans-theoretical theory of stages of change, empowerment-oriented counselling, goal-setting approach, self-efficacy and selfevaluation

20 Diabetes Prevention Program (DPP)(Australia) Goals: 1. no more than 30% energy from fat 2. no more than 10% energy from saturated fat 3. at least 15g/1000 kcal fibre min/day moderate intensity physical activity 5. 5% reduction in body weight Key findings: Participants improved significantly in all indicators with exception of systolic blood pressure. 75% of participants experienced waist reduction, and 68% experienced weight reduction. Significant changes in psychological measures (K-10, HADS, SF 36)

21 1. Diabetes Prevention Study (DPS in Finland) 2. GOAL program (Finland) 3. Diabetes Prevention Program (DPP in Australia) 4. Further scaling up in both Finland and Australia in last 5 years E.g. Life! Program in Australia

22 Programs evolve and are refined over time How to maintain intervention impact?? Need to plan for barriers and enablers to program adoption and international spread Different health care systems and cultures between countries make a difference Vibrant collaboration between researchers and program leaders across countries allowed for

23 The Finland Australian story the spread of diabetes prevention programs between Finland and Australia (2 very developed countries) How to transfer such programs to LMICs such as India and China? currently, a very small evidence base for the cultural and adaptation of such programs in LMICs

24 Daibetes Trends across SE Asia and South Asia

25 Diabetes Prevalence in Kerala and China Kerala, India 1 China 2 Age group Male Female Male Female NA NA Total Thankappan K R et al Indian J Med Res 2010; 131:53-63 (adapted). 2. Yang W et al N Engl J Med 2010; 362:

26 Study Type Prevention of T2DM Prevention of Complications Number of Studies found 3 4 Study Design 2 RCT, 1 communitybased All RCT Duration of studies 7 mths 6 years 3 6 mths Number of participants

27 Kerala Diabetes Prevention Program in Kerala, India ( )

28 Kerala Diabetes Prevention Program (K-DPP) A cluster randomised controlled trial of a group-based lifestyle intervention program integrated with local community and other initiatives Targeting individuals at high risk of developing type 2 diabetes mellitus (T2DM) in neighbourhoods from a rural district of Kerala State, India

29 Kerala Diabetes Prevention Program (K-DPP)

30 AIMS STUDY AIMS To implement and evaluate the K-DPP and its impact on T2DM incidence at 36 months compared with a standard care control group To identify individual-, household-, and neighbourhood-level factors likely to affect the wider uptake and operationalisation of K-DPP in India and other developing countries in the future To estimate the population health impact and costeffectiveness of screening and intervention in reducing the incidence of T2DM in a developing country with a very high prevalence of T2DM

31 Some key questions about global transfer of BM evidence base How to tailor programs to different communities, settings, cultures and countries? How to distinguish those program components that should be standardized vs those that may be tailored to local settings, needs, and opportunities? How to evaluate the success of contexualisation? What does treatment fidelity mean when interventions are in diverse cultural contexts?

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