title: An evaluation of the DEXLIFE 'self-selected' lifestyle intervention aimed at improving insulin sensitivity in people at risk of developing type 2 diabetes: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  With the global escalation of type 2 diabetes and evidence consistently showing that its onset can be prevented or delayed by changing lifestyle behaviours, there is an urgent need to translate practical, affordable and acceptable interventions from the research setting into the real world. One such approach to lifestyle interventions might be the introduction of a programme in which the individual is provided with choice and facilitated to 'self-select' an exercise programme. Previous research has shown that this is likely to be less resource intensive, an essential requirement for success outside the controlled research environment, while at the same time promoting positive responses relating to adherence, competence and self-efficacy, essential attributes for long-term success. Through a two-group parallel-randomised controlled trial, this study aims to assess the clinical and psychological impact of the DEXLIFE 'self-selected' lifestyle modification programme in adults at risk of developing type 2 diabetes.
  
  
  METHODS
  A total of 360 subjects at risk of developing type 2 diabetes are randomly assigned in a 1:3 ratio to a control (n = 90) or intervention arm (n = 270). Randomization is stratified by age, sex and body mass index. The control arm receives general information on lifestyle and diabetes risk. The intervention group participate in a 12 week 'self-selected' supervised exercise training programme accompanied with dietary advice to improve food choices. Participants are given access to Dublin City University Sport (an on-campus gym) and asked to perform four exercise classes per week. Dublin City University Sport offers over 50 classes per week, many of which are medically supervised. If weight loss is indicated, reduction in total calorie intake by 600 kcal/day is advised. Common to all food plans is <10% saturated fat intake, as well as a dietary fibre intake of >15 g/1000 kcal. Insulin sensitivity is the primary outcome measure. Secondary outcome measures include glucose function, fitness, body composition, anthropometrics, heart rate variability, lipid profiles, blood pressure, physical activity levels, dietary intake and quality of life.
  
  
  CONCLUSIONS
  "Self-selected" lifestyle intervention has not previously been evaluated in type 2 diabetes prevention and if shown to be successful could be implemented in practice immediately.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN66987085.
authors.affiliation: Centre for Preventive Medicine, School of Health and Human Performance, Dublin City University, Dublin, Ireland. grainne.odonoghue@dcu.ie.|Steno Diabetes Center, Gentofte, Denmark. grainne.odonoghue@dcu.ie.
authors.forename: Grainne M
authors.initials: GM
authors.lastname: O'Donoghue
authors.affiliation: Centre for Preventive Medicine, School of Health and Human Performance, Dublin City University, Dublin, Ireland. aileen.m.kennedy@dcu.ie.
authors.forename: Aileen
authors.initials: A
authors.lastname: Kennedy
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark. GSA@steno.dk.
authors.forename: Gregers Stig
authors.initials: GS
authors.lastname: Andersen
authors.affiliation: Centre for Preventive Medicine, School of Health and Human Performance, Dublin City University, Dublin, Ireland. eoin.durkan@dcu.ie.
authors.forename: Eoin
authors.initials: E
authors.lastname: Durkan
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark. TTHY@steno.dk.
authors.forename: Tanja
authors.initials: T
authors.lastname: Thybo
authors.affiliation: Vhi Healthcare Ltd, Dublin, Republic of Ireland.
authors.forename: Margaret
authors.initials: M
authors.lastname: Sinnott
authors.affiliation: Steno Diabetes Center, Gentofte, Denmark. JJNL@steno.dk.
authors.forename: John J
authors.initials: JJ
authors.lastname: Nolan
authors.affiliation: Centre for Preventive Medicine, School of Health and Human Performance, Dublin City University, Dublin, Ireland. donal.ogorman@dcu.ie.
authors.forename: Donal J
authors.initials: DJ
authors.lastname: O'Gorman
mesh_terms: D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D004032:Diet / Q000009:adverse effects; D002149:Energy Intake; D015444:Exercise; D005247:Feeding Behavior; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D007494:Ireland; D010353:Patient Education as Topic; D011322:Primary Prevention / Q000379:methods*; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012648:Self Care; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D007328:Insulin