Anne Karen Jenum1, Idunn Brekke2,3, Ibrahimu Mdala4, Mirthe Muilwijk5, Ambady Ramachandran6,7, Marte Kjøllesdal8, Eivind Andersen9, Kåre R Richardsen10, Anne Douglas11, Genevieve Cezard11,12, Aziz Sheikh11, Carlos A Celis-Morales13, Jason M R Gill13, Naveed Sattar13, Raj S Bhopal11, Erik Beune5, Karien Stronks5, Per Olav Vandvik14, Irene G M van Valkengoed5. 1. General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, Faculty of Medicine, University of Oslo, Post Box 1130 Blindern, 0318, Oslo, Norway. a.k.jenum@medisin.uio.no. 2. Centre for Welfare and Labour Research, Norwegian Social Research, OsloMet - Oslo Metropolitan University, Oslo, Norway. 3. Faculty of Health Sciences, Department of Nursing and Health Promotion, OsloMet - Oslo Metropolitan University, Oslo, Norway. 4. General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, Faculty of Medicine, University of Oslo, Post Box 1130 Blindern, 0318, Oslo, Norway. 5. Department of Public Health, Amsterdam Public Health Research Institute, University of Amsterdam, Amsterdam, the Netherlands. 6. India Diabetes Research Foundation, Chennai, India. 7. Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India. 8. Department of Community Medicine and Global Health, Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway. 9. Faculty of Humanities, Sports and Educational Science, University of South-Eastern Norway, Borre, Norway. 10. Department of Physiotherapy, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway. 11. Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK. 12. Population and Health Research Group, School of Geography and Sustainable Development, University of St Andrews, Fife, Scotland, UK. 13. Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK. 14. Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway.
Abstract
AIMS/HYPOTHESIS: Individuals of South Asian origin have a high risk of type 2 diabetes and of dying from a diabetes-attributable cause. Lifestyle modification intervention trials to prevent type 2 diabetes in high-risk South Asian adults have suggested more modest effects than in European-origin populations. The strength of the evidence of individual studies is limited, however. We performed an individual participant data meta-analysis of available RCTs to assess the effectiveness of lifestyle modification in South Asian populations worldwide. METHODS: We searched PubMed, EMBASE, Cochrane Library and Web of Science (to 24 September 2018) for RCTs on lifestyle modification interventions incorporating diet and/or physical activity in South Asian adults. Reviewers identified eligible studies and assessed the quality of the evidence. We obtained individual participant data on 1816 participants from all six eligible trials (four from Europe and two from India). We generated HR estimates for incident diabetes (primary outcome) and mean differences for fasting glucose, 2 h glucose, weight and waist circumference (secondary outcomes) using mixed-effect meta-analysis overall and by pre-specified subgroups. We used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to rate the quality of evidence of the estimates. The study is registered with the International Prospective Register of Systematic Reviews ([PROSPERO] CRD42017078003). RESULTS: Incident diabetes was observed in 12.6% of participants in the intervention groups and in 20.0% of participants in the control groups. The pooled HR for diabetes incidence was 0.65 (95% CI 0.51, 0.81; I2 = 0%) in intervention compared with control groups. The absolute risk reduction was 7.4% (95% CI 4.0, 10.2), with no interactions for the pre-specified subgroups (sex, BMI, age, study duration and region where studies were performed). The quality of evidence was rated as moderate. Mean difference for lifestyle modification vs control groups for 2 h glucose was -0.34 mmol/l (95% CI -0.62, -0.07; I2 = 50%); for weight -0.75 kg (95% CI -1.34, -0.17; I2 = 71%) and for waist -1.16 cm (95% CI -2.16, -0.16; I2 = 75%). No effect was found for fasting glucose. Findings were similar across subgroups, except for weight for European vs Indian studies (-1.10 kg vs -0.08 kg, p = 0.02 for interaction). CONCLUSIONS/ INTERPRETATION: Despite modest changes for adiposity, lifestyle modification interventions in high-risk South Asian populations resulted in a clinically important 35% relative reduction in diabetes incidence, consistent across subgroups. If implemented on a large scale, lifestyle modification interventions in high-risk South Asian populations in Europe would reduce the incidence of diabetes in these populations.
AIMS/HYPOTHESIS: Individuals of South Asian origin have a high risk of type 2 diabetes and of dying from a diabetes-attributable cause. Lifestyle modification intervention trials to prevent type 2 diabetes in high-risk South Asian adults have suggested more modest effects than in European-origin populations. The strength of the evidence of individual studies is limited, however. We performed an individual participant data meta-analysis of available RCTs to assess the effectiveness of lifestyle modification in South Asian populations worldwide. METHODS: We searched PubMed, EMBASE, Cochrane Library and Web of Science (to 24 September 2018) for RCTs on lifestyle modification interventions incorporating diet and/or physical activity in South Asian adults. Reviewers identified eligible studies and assessed the quality of the evidence. We obtained individual participant data on 1816 participants from all six eligible trials (four from Europe and two from India). We generated HR estimates for incident diabetes (primary outcome) and mean differences for fasting glucose, 2 h glucose, weight and waist circumference (secondary outcomes) using mixed-effect meta-analysis overall and by pre-specified subgroups. We used the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system to rate the quality of evidence of the estimates. The study is registered with the International Prospective Register of Systematic Reviews ([PROSPERO] CRD42017078003). RESULTS: Incident diabetes was observed in 12.6% of participants in the intervention groups and in 20.0% of participants in the control groups. The pooled HR for diabetes incidence was 0.65 (95% CI 0.51, 0.81; I2 = 0%) in intervention compared with control groups. The absolute risk reduction was 7.4% (95% CI 4.0, 10.2), with no interactions for the pre-specified subgroups (sex, BMI, age, study duration and region where studies were performed). The quality of evidence was rated as moderate. Mean difference for lifestyle modification vs control groups for 2 h glucose was -0.34 mmol/l (95% CI -0.62, -0.07; I2 = 50%); for weight -0.75 kg (95% CI -1.34, -0.17; I2 = 71%) and for waist -1.16 cm (95% CI -2.16, -0.16; I2 = 75%). No effect was found for fasting glucose. Findings were similar across subgroups, except for weight for European vs Indian studies (-1.10 kg vs -0.08 kg, p = 0.02 for interaction). CONCLUSIONS/ INTERPRETATION: Despite modest changes for adiposity, lifestyle modification interventions in high-risk South Asian populations resulted in a clinically important 35% relative reduction in diabetes incidence, consistent across subgroups. If implemented on a large scale, lifestyle modification interventions in high-risk South Asian populations in Europe would reduce the incidence of diabetes in these populations.
Entities:
Keywords:
Diet; Individual participant data meta-analysis; Lifestyle intervention; Physical activity; Prevention; RCT; South Asians; Type 2 diabetes
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