An evaluation of Croí MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial

Trials

Brian E McGuire³  John Newell⁴  Eoin Noctor⁶  Liam G Glynn¹  Irene Gibson⁵  Paddy Gillespie²  Angela O’Dea⁶  Fidelma P Dunne⁶  Jennifer J Infanti⁶ 

[1] Discipline of General Practice, School of Medicine, National University of Ireland Galway, 1 Distillery Road, Galway, Ireland;J.E. Cairnes School of Business & Economics, Cairnes Building, National University of Ireland Galway, Galway, Ireland;School of Psychology, National University of Ireland Galway, University Road, Galway, Ireland;HRB Clinical Research Facility Galway, National University of Ireland Galway, University Road, Galway, Ireland;Croí–The West of Ireland Cardiac Foundation, Croí House, Moyola Lane, Newcastle, Galway, Ireland;School of Medicine, Clinical Sciences Institute, National University of Ireland Galway, Galway, Ireland

关键词: Randomised controlled trial;    Interdisciplinary approach;    Lifestyle intervention;    Risk factor modification;    Pre-diabetes;    Gestational diabetes mellitus;   

Others  :  1094146
DOI  :  10.1186/1745-6215-14-121

 received in 2012-12-18, accepted in 2013-04-18,  发布年份 2013

【 摘 要 】

Background

Universal screening using the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria has identified a prevalence of gestational diabetes mellitus (GDM) of 12.4% in women living in Ireland. Women with prior GDM are at increased risk of developing type 2 diabetes later in life. A number of risk factors linked to the development of type 2 diabetes are potentially modifiable through lifestyle and behaviour changes, and medical management. No previous Irish studies have adequately investigated the efficacy of lifestyle intervention programmes in reducing these risk factors in women with prior GDM. Through a two-group, parallel randomised controlled trial (RCT), this study aims to assess the clinical impact, cost-effectiveness and psychological experience of the Croí MyAction intensive lifestyle modification programme for women with prior GDM.

Methods/Design

A total of 54 women with a history of GDM and persistent post-partum glucose dysfunction (impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)), are randomly assigned to a control arm (n = 27) or to the Croí MyAction intervention group (n = 27). The control arm receives usual health care advice - written information on diet and lifestyle changes for reducing diabetes risks and visits with general practitioners as required. The intervention group receives usual health care as per the control group in addition to attending a 12-week intensive lifestyle modification programme known as Croí MyAction. Croí MyAction involves 2.5 hour sessions once per week (for 12 weeks) comprising a group exercise programme, group health promotion or education seminars, and one-to-one meetings with a multidisciplinary health care team to personalise risk factor reductions. Randomisation and allocation to the intervention arms is carried out by an independent researcher, ensuring that the allocation sequence is concealed from study researchers until the interventions are assigned. The primary analysis is based on glucose dysfunction, comparing a mean reduction in fasting plasma glucose (FPG) levels on a 75 gram oral glucose tolerance test (OGTT) in the two groups at a one-year, post-intervention follow-up. The trial is funded by the Irish Health Research Board (HRB). Ethics approval was obtained on 27 March 2012 from the Clinical Research Ethics Committee, Galway University Hospitals, Health Service Executive of Ireland (Ref: C.A.691).

Trial registration

Current Controlled Trials ISRCTN41202110.

【 授权许可】

   
2013 Infanti et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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