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

Autor: Tanja Thybo, Grainne O'Donoghue, Margaret Sinnott, Eoin Durkan, John J. Nolan, Aileen Kennedy, Donal J. O’Gorman, Gregers S. Andersen
Jazyk: angličtina
Předmět:
Blood Glucose
Lifestyle intervention
Research design
Gerontology
Health Knowledge
Attitudes
Practice
Time Factors
Health Behavior
Psychological intervention
Medicine (miscellaneous)
Type 2 diabetes
law.invention
Study Protocol
0302 clinical medicine
Clinical Protocols
Randomized controlled trial
Risk Factors
Weight loss
law
Food choice
Insulin
Pharmacology (medical)
030212 general & internal medicine
Randomised controlled trial
2. Zero hunger
Self-selected
Insulin sensitivity
3. Good health
Primary Prevention
Treatment Outcome
Research Design
medicine.symptom
Diabetes risk
Insulin sensitivity
Lifestyle intervention
Prevention
Randomised controlled trial
Self-selected
Type 2 diabetes
030209 endocrinology & metabolism
03 medical and health sciences
Patient Education as Topic
medicine
Humans
Exercise
business.industry
Prevention
Feeding Behavior
medicine.disease
Diet
Self Care
Diabetes Mellitus
Type 2
Insulin Resistance
Energy Intake
business
Ireland
Risk Reduction Behavior
Body mass index
Biomarkers
Zdroj: Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-015-1042-1
Popis: 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/design 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 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. Discussion "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. Trial registration Current Controlled Trials: ISRCTN66987085. Electronic supplementary material The online version of this article (doi:10.1186/s13063-015-1042-1) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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