The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial
Background: People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. Hypothesis: Compared to usual care, the risk of T2D can be r...
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| Format: | Journal Article |
| Language: | English |
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2022
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| Online Access: | https://hdl.handle.net/10356/163013 |
| _version_ | 1811697600274890752 |
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| author | Kasturiratne, Anuradhani Khawaja, Khadija I. Ahmad, Sajjad Siddiqui, Samreen Shahzad, Khurram Athauda, Lathika K. Jayawardena, Ranil Mahmood, Sara Muilwijk, Mirthe Batool, Tayyaba Burney, Saira Glover, Matthew Palaniswamy, Saranya Bamunuarachchi, Vodathi Panda, Manju Madawanarachchi, Suren Rai, Baldeesh Sattar, Iqra Silva, Wnurinham Waghdhare, Swati Jarvelin, Marjo-Riitta Rannan-Eliya, Ravindra P. Gage, Heather M. van Valkengoed, Irene G. M. Valabhji, Jonathan Frost, Gary S. Loh, Marie Wickremasinghe, Ananda R. Kooner, Jaspal S. Katulanda, Prasad Jha, Sujeet Chambers, John C. |
| author2 | Lee Kong Chian School of Medicine (LKCMedicine) |
| author_facet | Lee Kong Chian School of Medicine (LKCMedicine) Kasturiratne, Anuradhani Khawaja, Khadija I. Ahmad, Sajjad Siddiqui, Samreen Shahzad, Khurram Athauda, Lathika K. Jayawardena, Ranil Mahmood, Sara Muilwijk, Mirthe Batool, Tayyaba Burney, Saira Glover, Matthew Palaniswamy, Saranya Bamunuarachchi, Vodathi Panda, Manju Madawanarachchi, Suren Rai, Baldeesh Sattar, Iqra Silva, Wnurinham Waghdhare, Swati Jarvelin, Marjo-Riitta Rannan-Eliya, Ravindra P. Gage, Heather M. van Valkengoed, Irene G. M. Valabhji, Jonathan Frost, Gary S. Loh, Marie Wickremasinghe, Ananda R. Kooner, Jaspal S. Katulanda, Prasad Jha, Sujeet Chambers, John C. |
| author_sort | Kasturiratne, Anuradhani |
| collection | NTU |
| description | Background: People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. Hypothesis: Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers. Design: Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years. Entry criteria: South Asian, men or women, age 40–70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0–6.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index < 22 kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness. Endpoints: The primary endpoint is new-onset T2D at 3 years, defined as (i) HbA1c ≥ 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are the following: (i) physical measures: waist circumference, weight and blood pressure; (ii) lifestyle measures: smoking status, alcohol intake, physical activity and dietary intake; (iii) biochemical measures: fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and (iv) treatment compliance. Intervention: Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one sessions, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving a 7% reduction in body mass index and a 10-cm reduction in waist circumference through (i) improved diet and (ii) increased physical activity. Usual care comprised a single 30-min session of lifestyle modification advice from the community health worker. Results: We screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom 3682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between intervention and usual care sites. More than 90% of follow-up visits are scheduled to be complete in December 2020. Based on the follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum). Conclusion: The iHealth-T2D study will advance understanding of strategies for the prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group. IRB approval: 16/WM/0171. Trial registration: EudraCT 2016-001350-18. Registered on 14 April 2016. ClinicalTrials.gov NCT02949739. Registered on 31 October 2016, First posted on 31/10/2016. |
| first_indexed | 2024-10-01T07:57:50Z |
| format | Journal Article |
| id | ntu-10356/163013 |
| institution | Nanyang Technological University |
| language | English |
| last_indexed | 2024-10-01T07:57:50Z |
| publishDate | 2022 |
| record_format | dspace |
| spelling | ntu-10356/1630132023-03-05T16:51:21Z The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial Kasturiratne, Anuradhani Khawaja, Khadija I. Ahmad, Sajjad Siddiqui, Samreen Shahzad, Khurram Athauda, Lathika K. Jayawardena, Ranil Mahmood, Sara Muilwijk, Mirthe Batool, Tayyaba Burney, Saira Glover, Matthew Palaniswamy, Saranya Bamunuarachchi, Vodathi Panda, Manju Madawanarachchi, Suren Rai, Baldeesh Sattar, Iqra Silva, Wnurinham Waghdhare, Swati Jarvelin, Marjo-Riitta Rannan-Eliya, Ravindra P. Gage, Heather M. van Valkengoed, Irene G. M. Valabhji, Jonathan Frost, Gary S. Loh, Marie Wickremasinghe, Ananda R. Kooner, Jaspal S. Katulanda, Prasad Jha, Sujeet Chambers, John C. Lee Kong Chian School of Medicine (LKCMedicine) Science::Medicine Cholesterol Blood Level Dietary Intake Background: People from South Asia are at increased risk of type 2 diabetes (T2D). There is an urgent need to develop approaches for the prevention of T2D in South Asians that are cost-effective, generalisable and scalable across settings. Hypothesis: Compared to usual care, the risk of T2D can be reduced amongst South Asians with central obesity or raised HbA1c, through a 12-month lifestyle modification programme delivered by community health workers. Design: Cluster randomised clinical trial (1:1 allocation to intervention or usual care), carried out in India, Pakistan, Sri Lanka and the UK, with 30 sites per country (120 sites total). Target recruitment 3600 (30 participants per site) with annual follow-up for 3 years. Entry criteria: South Asian, men or women, age 40–70 years with (i) central obesity (waist circumference ≥ 100 cm in India and Pakistan; ≥90 cm in Sri Lanka) and/or (ii) prediabetes (HbA1c 6.0–6.4% inclusive). Exclusion criteria: known type 1 or 2 diabetes, normal or underweight (body mass index < 22 kg/m2); pregnant or planning pregnancy; unstable residence or planning to leave the area; and serious illness. Endpoints: The primary endpoint is new-onset T2D at 3 years, defined as (i) HbA1c ≥ 6.5% or (ii) physician diagnosis and on treatment for T2D. Secondary endpoints at 1 and 3 years are the following: (i) physical measures: waist circumference, weight and blood pressure; (ii) lifestyle measures: smoking status, alcohol intake, physical activity and dietary intake; (iii) biochemical measures: fasting glucose, insulin and lipids (total and HDL cholesterol, triglycerides); and (iv) treatment compliance. Intervention: Lifestyle intervention (60 sites) or usual care (60 sites). Lifestyle intervention was delivered by a trained community health worker over 12 months (5 one-one sessions, 4 group sessions, 13 telephone sessions) with the goal of the participants achieving a 7% reduction in body mass index and a 10-cm reduction in waist circumference through (i) improved diet and (ii) increased physical activity. Usual care comprised a single 30-min session of lifestyle modification advice from the community health worker. Results: We screened 33,212 people for inclusion into the study. We identified 10,930 people who met study entry criteria, amongst whom 3682 agreed to take part in the intervention. Study participants are 49.2% female and aged 52.8 (SD 8.2) years. Clinical characteristics are well balanced between intervention and usual care sites. More than 90% of follow-up visits are scheduled to be complete in December 2020. Based on the follow-up to end 2019, the observed incidence of T2D in the study population is in line with expectations (6.1% per annum). Conclusion: The iHealth-T2D study will advance understanding of strategies for the prevention of diabetes amongst South Asians, use approaches for screening and intervention that are adapted for low-resource settings. Our study will thus inform the implementation of strategies for improving the health and well-being of this major global ethnic group. IRB approval: 16/WM/0171. Trial registration: EudraCT 2016-001350-18. Registered on 14 April 2016. ClinicalTrials.gov NCT02949739. Registered on 31 October 2016, First posted on 31/10/2016. Published version The research was supported by the European Union H2020 program (iHealth-T2D, 643774). JCC, JSK, GF, BR and WS are also supported in part by the National Institute for Health Research (NIHR) (16/136/68) using UK aid from the UK Government to support global health research. European Commission (award 643774) and National Institute for Health Research (award 16/136/68). 2022-11-16T00:21:49Z 2022-11-16T00:21:49Z 2021 Journal Article Kasturiratne, A., Khawaja, K. I., Ahmad, S., Siddiqui, S., Shahzad, K., Athauda, L. K., Jayawardena, R., Mahmood, S., Muilwijk, M., Batool, T., Burney, S., Glover, M., Palaniswamy, S., Bamunuarachchi, V., Panda, M., Madawanarachchi, S., Rai, B., Sattar, I., Silva, W., ...Chambers, J. C. (2021). The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial. Trials, 22(1), 928-. https://dx.doi.org/10.1186/s13063-021-05803-7 1745-6215 https://hdl.handle.net/10356/163013 10.1186/s13063-021-05803-7 34922608 2-s2.0-85121433492 1 22 928 en Trials © The Author(s). 2021 Open Access. 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The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. application/pdf |
| spellingShingle | Science::Medicine Cholesterol Blood Level Dietary Intake Kasturiratne, Anuradhani Khawaja, Khadija I. Ahmad, Sajjad Siddiqui, Samreen Shahzad, Khurram Athauda, Lathika K. Jayawardena, Ranil Mahmood, Sara Muilwijk, Mirthe Batool, Tayyaba Burney, Saira Glover, Matthew Palaniswamy, Saranya Bamunuarachchi, Vodathi Panda, Manju Madawanarachchi, Suren Rai, Baldeesh Sattar, Iqra Silva, Wnurinham Waghdhare, Swati Jarvelin, Marjo-Riitta Rannan-Eliya, Ravindra P. Gage, Heather M. van Valkengoed, Irene G. M. Valabhji, Jonathan Frost, Gary S. Loh, Marie Wickremasinghe, Ananda R. Kooner, Jaspal S. Katulanda, Prasad Jha, Sujeet Chambers, John C. The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial |
| title | The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial |
| title_full | The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial |
| title_fullStr | The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial |
| title_full_unstemmed | The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial |
| title_short | The iHealth-T2D study, prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes: study protocol for a randomised controlled trial |
| title_sort | ihealth t2d study prevention of type 2 diabetes amongst south asians with central obesity and prediabetes study protocol for a randomised controlled trial |
| topic | Science::Medicine Cholesterol Blood Level Dietary Intake |
| url | https://hdl.handle.net/10356/163013 |
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