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A pragmatic lifestyle modification programme reduces the incidence of predictors of cardio-metabolic disease and dysglycaemia in a young healthy urban South Asian population: a randomised controlled trial
Wijesuriya M, Fountoulakis N, Guess N, Banneheka S, Vasantharajah L, Gulliford M, Viberti G, Gnudi L, Karalliedde J
BMC Medicine 2017 Aug 30;15(146):Epub
clinical trial
5/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: There is an increasing incidence of type 2 diabetes mellitus (T2DM) in young urban South-Asians. We tested the effect of a pragmatic trimonthly lifestyle modification (LSM) programme (P-LSM) versus a less-intensive 12-monthly control LSM (C-LSM) intervention on a primary composite endpoint of predictors of cardio-metabolic disease (new onset T2DM, hypertension, impaired glucose tolerance (IGT), impaired fasting glycaemia (IFG) and markers of cardio-renal disease) in participants aged 5 to 40 years with risk factors for T2DM. METHODS: This was a randomised controlled trial performed at the National Diabetes Centre, Sri-Lanka. We individually randomised 4,672 participants at risk of T2DM, of whom 3,539 (mean age 22.5 (range 6 to 40 years, 48% males) received either trimonthly (P-LSM n = 1,726) or 12-monthly (C-LSM n = 1,813) peer educator advice aimed at reducing weight, improving diet, reducing psychological stress and increasing physical activity. RESULTS: During a median follow-up of 3 years, the cumulative incidence of the primary endpoint was n = 479 in P-LSM (74 per 1,000 person years) versus 561 in C-LSM (96 per 1,000 person years), with an incident rate ratio (IRR) of 0.89 (95% CI 0.83 to 0.96, p = 0.02). In post hoc analyses, new onset dysglycaemia (T2DM, IFG and IGT), was the major contributor to the composite and was significantly reduced by P-LSM (IRR 0.9, 95% CI 0.83 to 0.97, p = 0.01). A significant impact of P-LSM on the incidence of the composite endpoint was noted in 1725 participants (P-LSM n = 850, C-LSM n = 875) aged below 18; P-LSM n = 140 (48 per 1,000 person years) versus C-LSM n = 174 (55.4 per 1,000 person years), with an IRR of 0.83 (95% CI 0.73 to 0.94, p = 0.004). CONCLUSIONS: In a young at-risk South-Asian population, a pragmatic LSM programme significantly reduces the incidence of predictors of cardio-metabolic disease. Our results highlight the importance of early intervention in young at-risk subjects. TRIAL REGISTRATION: World Health Organization international clinical trial registry platform (SLCTR/2008/003). REGISTRATION DATE: March 28, 2008. Retrospectively registered.

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