iHealth-T2D
Research type
Research Study
Full title
Lifestyle intervention to prevent Type 2 Diabetes amongst South Asians with central obesity and prediabetes
IRAS ID
182806
Contact name
John Campbell Chambers
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 31 days
Research summary
iHealth-T2D aims to develop approaches to health promotion through lifestyle modification (healthy diet, increased physical activity) that are clinically effective and efficient for prevention of T2D in South Asian communities from diverse settings. \nWe will recruit 3,600 South Asians men and women, aged 40-70 years, who have central adiposity (waist circumference≥100cm) or prediabetes (HbA1c≥6.0%), but who do not yet have diabetes. South Asian participants will be recruited from India, Pakistan, Sri Lanka and the UK (900 people per country). Index cases will receive either i. Intensive lifestyle modification (N=1,800); or ii. usual care (N=1,800). Allocation to active or control group will be by cluster randomization. Lifestyle intervention will comprise 22 sessions of lifestyle modification over 12 months, delivered by a trained health educator, and involving available family members. Usual care group will comprise one diabetes prevention session and written material. All participants will be followed annually for three years to identify new-onset T2D (primary endpoint, HbA1c≥6.5%).\nThe primary analyses will determine the clinical and cost-effectiveness of family-based intensive lifestyle modification vs usual care for prevention of T2D amongst South Asians with i. central obesity; ii. prediabetes or iii, overall. Secondary analyses will address clinical and biochemical measures of metabolic health similarly. All analyses will be intention to treat. \n
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0171
Date of REC Opinion
14 Apr 2016
REC opinion
Favourable Opinion