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

Objective

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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RIA - Research and Innovation action

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(opens in new window) H2020-HCO-2014-2015

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Coordinator

IMPERIAL COLLEGE OF SCIENCE TECHNOLOGY AND MEDICINE
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 1 386 972,50
Address
SOUTH KENSINGTON CAMPUS EXHIBITION ROAD
SW7 2AZ LONDON
United Kingdom

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Region
London Inner London — West Westminster
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 1 386 972,50

Participants (10)

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