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Family-based intervention to improve healthy lifestyle and prevent Type 2 Diabetes amongst South Asians with central obesity and prediabetes

Ziel

South Asians, who represent one-quarter of the world’s population, are at high risk of type-2 diabetes (T2D). Intensive lifestyle modification (healthy diet and physical activity) is effective at preventing T2D amongst South Asians with impaired glucose tolerance, but this approach is limited by high-cost, poor scalability and low impact on T2D burden.
We will complete a cluster-randomised clinical trial at 120 locations across India, Pakistan, Sri Lanka and the UK. We will compare family-based intensive lifestyle modification (22 health promotion sessions from a community health worker, active group, N=60 sites) vs usual care (1 session, control group, N=60 sites) for prevention of T2D, amongst 3,600 non-diabetic South Asian men and women with central obesity (waist≥100cm) and/or prediabetes (HbA1c≥6.0%). Participants will be followed annually for 3 years. The primary endpoint will be new-onset T2D (physician diagnosis on treatment or HbA1c≥6.0%, predicted N~734 over 3 years). Secondary endpoints will include waist and weight in the index case and family members. Our study has 80% power to identify a reduction in T2D risk with family-based intervention vs usual care of: 30% in South Asians with central obesity; 24% in South Asians with prediabetes; and 24% overall. Health economic evaluation will determine cost-effectiveness of family based lifestyle modification for prevention of T2D amongst South Asians with central obesity and / or prediabetes. The impact of gender and socio-economic factors on clinical utility and cost-effectiveness will be investigated.
Our results will determine whether screening by waist circumference and/or HbA1c, coupled with intervention by family-based lifestyle modification, is an efficient, effective and equitable strategy for prevention of T2D in South Asians. Our findings will thereby provide a robust evidence base for scalable community-wide approaches to reverse the epidemic of T2D amongst the >1.5 billion South Asians worldwide.

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H2020-HCO-2014
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IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE
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DEVKI DEVI FOUNDATION SOCIETY
Indien
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UNIVERSITY OF COLOMBO
Sri Lanka
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00300 Colombo Western Province
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Higher or Secondary Education Establishments
UNIVERSITY OF KELANIYA
Sri Lanka
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Dalugama
Kelaniya
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UNIVERSITY OF SURREY
United Kingdom
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Stag Hill
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LONDON NORTH WEST HEALTHCARE NATIONAL HEALTH SERVICE TRUST
United Kingdom
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INSTITUTE FOR HEALTH POLICY
Sri Lanka
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Colombo
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ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM
Niederlande
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1105AZ Amsterdam
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OULUN YLIOPISTO
Finnland
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Pentti Kaiteran Katu 1
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Pakistan
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SERVICES INSTITUTE OF MEDICAL SCIENCES
Pakistan
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54000 Lahore
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