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The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes-a statistical analysis plan

Current controlled trials in cardiovascular medicine, 2022-09, Vol.23 (1), p.755-755, Article 755 [Peer Reviewed Journal]

2022. The Author(s). ;COPYRIGHT 2022 BioMed Central Ltd. ;The Author(s) 2022. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;The Author(s) 2022 ;ISSN: 1745-6215 ;EISSN: 1745-6215 ;EISSN: 1468-6694 ;DOI: 10.1186/s13063-022-06667-1 ;PMID: 36068618

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Title:
The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes-a statistical analysis plan
Author: Muilwijk, Mirthe ; Loh, Marie ; Mahmood, Sara ; Palaniswamy, Saranya ; Siddiqui, Samreen ; Silva, Wnurinham ; Frost, Gary S ; Gage, Heather M ; Jarvelin, Marjo-Riitta ; Rannan-Eliya, Ravindra P ; Ahmad, Sajjad ; Jha, Sujeet ; Kasturiratne, Anuradhani ; Katulanda, Prasad ; Khawaja, Khadija I ; Kooner, Jaspal S ; Wickremasinghe, Ananda R ; van Valkengoed, Irene G M ; Chambers, John C
Subjects: Adult ; Aged ; Asian People ; Asians ; Cardiovascular disease ; Community health care ; Consent ; Cost analysis ; Demographic aspects ; Diabetes ; Diabetes Mellitus, Type 2 - diagnosis ; Diabetes Mellitus, Type 2 - prevention & control ; Female ; Field study ; Glucose ; Health aspects ; Humans ; Intervention ; Life style ; Lifestyle intervention ; Lifestyles ; Male ; Middle Aged ; Obesity ; Obesity, Abdominal - diagnosis ; Obesity, Abdominal - prevention & control ; Performance evaluation ; Prediabetic State - diagnosis ; Prediabetic State - therapy ; Prevention ; Risk factors ; South Asian ; Sri Lanka ; Statistical analysis ; Study Protocol ; Type 2 diabetes ; Workers
Is Part Of: Current controlled trials in cardiovascular medicine, 2022-09, Vol.23 (1), p.755-755, Article 755
Description: South Asians are at high risk of type 2 diabetes (T2D). Lifestyle modification is effective at preventing T2D amongst South Asians, but the approaches to screening and intervention are limited by high costs, poor scalability and thus low impact on T2D burden. An intensive family-based lifestyle modification programme for the prevention of T2D was developed. The aim of the iHealth-T2D trial is to compare the effectiveness of this programme with usual care. The iHealth-T2D trial is designed as a cluster randomised controlled trial (RCT) conducted at 120 sites across India, Pakistan, Sri Lanka and the UK. A total of 3682 South Asian men and women with age between 40 and 70 years without T2D but at elevated risk for T2D [defined by central obesity (waist circumference ≥ 95 cm in Sri Lanka or ≥ 100 cm in India, Pakistan and the UK) and/or prediabetes (HbA1c ≥ 6.0%)] were included in the trial. Here, we describe in detail the statistical analysis plan (SAP), which was finalised before outcomes were available to the investigators. The primary outcome will be evaluated after 3 years of follow-up after enrolment to the study and is defined as T2D incidence in the intervention arm compared to usual care. Secondary outcomes are evaluated both after 1 and 3 years of follow-up and include biochemical measurements, anthropometric measurements, behavioural components and treatment compliance. The iHealth-T2D trial will provide evidence of whether an intensive family-based lifestyle modification programme for South Asians who are at high risk for T2D is effective in the prevention of T2D. The data from the trial will be analysed according to this pre-specified SAP. The trial was approved by the international review board of each participating study site. Study findings will be disseminated through peer-reviewed publications and in conference presentations. EudraCT 2016-001,350-18 . Registered on 14 April 2016. gov NCT02949739 . Registered on 31 October 2016.
Publisher: England: BioMed Central Ltd
Language: English
Identifier: ISSN: 1745-6215
EISSN: 1745-6215
EISSN: 1468-6694
DOI: 10.1186/s13063-022-06667-1
PMID: 36068618
Source: GFMER Free Medical Journals
MEDLINE
PubMed Central
Alma/SFX Local Collection
ROAD: Directory of Open Access Scholarly Resources
ProQuest Central
DOAJ Directory of Open Access Journals
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The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes-a statistical analysis plan

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