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.
Lifestyle intervention
South Asian
Type 2 diabetes
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
06 Sep 2022
06 Sep 2022
Historique:
received:
17
05
2021
accepted:
18
08
2022
entrez:
6
9
2022
pubmed:
7
9
2022
medline:
9
9
2022
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
BACKGROUND
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.
METHODS
METHODS
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.
DISCUSSION
CONCLUSIONS
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.
ETHICS AND DISSEMINATION
BACKGROUND
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.
TRIAL REGISTRATION
BACKGROUND
EudraCT 2016-001,350-18 . Registered on 14 April 2016.
CLINICALTRIALS
RESULTS
gov NCT02949739 . Registered on 31 October 2016.
Identifiants
pubmed: 36068618
doi: 10.1186/s13063-022-06667-1
pii: 10.1186/s13063-022-06667-1
pmc: PMC9450360
doi:
Banques de données
ClinicalTrials.gov
['NCT02949739']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
755Subventions
Organisme : Horizon 2020 Framework Programme
ID : 643774
Informations de copyright
© 2022. The Author(s).
Références
Ann Fam Med. 2012 May-Jun;10(3):235-40
pubmed: 22585888
Int J Behav Nutr Phys Act. 2015 Jan 24;12:4
pubmed: 25616598
Perspect Clin Res. 2011 Jul;2(3):109-12
pubmed: 21897887
J Clin Epidemiol. 2017 Jul;87:70-77
pubmed: 28400294
BMC Med Res Methodol. 2017 Dec 6;17(1):162
pubmed: 29207961
BMJ. 2012 Sep 04;345:e5661
pubmed: 22951546
Stat Methods Med Res. 2018 Sep;27(9):2610-2626
pubmed: 28034175
Crit Care Resusc. 2009 Mar;11(1):5-6
pubmed: 19281437
Diabetes Care. 2003 Dec;26(12):3230-6
pubmed: 14633807
JAMA. 2017 Dec 19;318(23):2337-2343
pubmed: 29260229
N Engl J Med. 2008 Jun 12;358(24):2560-72
pubmed: 18539916
Intern Emerg Med. 2016 Apr;11(3):327-40
pubmed: 26370238
Clin Trials. 2012 Aug;9(4):396-407
pubmed: 22752633
BMC Med Res Methodol. 2002 Jun 17;2:8
pubmed: 12069695
World J Diabetes. 2016 Sep 15;7(17):396-405
pubmed: 27660696
J Clin Epidemiol. 2019 Jun;110:63-73
pubmed: 30878639
PLoS Med. 2009 May 26;6(5):e1000065
pubmed: 19536323
Yale J Biol Med. 2013 Sep 20;86(3):343-58
pubmed: 24058309
Ann Glob Health. 2019 Nov 20;85(1):137
pubmed: 31807416
PeerJ. 2017 Jul 7;5:e3544
pubmed: 28698825
Pharmacol Res. 2016 Nov;113(Pt A):600-609
pubmed: 27697647
BMC Med Res Methodol. 2011 May 23;11:77
pubmed: 21605357
J Clin Epidemiol. 2004 Aug;57(8):785-94
pubmed: 15485730
Diabetes Care. 2002 Dec;25(12):2165-71
pubmed: 12453955
Diabetologia. 2019 Aug;62(8):1337-1348
pubmed: 31201437
Ann N Y Acad Sci. 2013 Apr;1281:51-63
pubmed: 23317344
Diabet Med. 2013 Jan;30(1):26-34
pubmed: 22827704
Lancet Diabetes Endocrinol. 2015 Jul;3(7):526-534
pubmed: 26095709
Control Clin Trials. 2001 Apr;22(2):102-10
pubmed: 11306148