![]() However, RCTs are designed to test whether interventions have the hypothesised effect on chosen outcomes, but they do not however, clarify how, for example whether patient activation led to the effects seen. Furthermore, the trial pointed towards effect, however not statistically significant, on patient activation i.e., a person’s knowledge, skill and confidence related to managing health at three and 12 months. The intervention “Live your life without diabetes” was evaluated in a randomised controlled trial (RCT) showing effects on waist circumference and systolic blood pressure and pointed towards effect on weight, at 12 month among Danish adults at high risk of type 2 diabetes. They hypothesised that improved knowledge, skills and confidence to manage health among the participants would lead to behaviour change regarding diet and physical activity leading to weight loss as the primary 12-month outcome. It is a challenge for health care systems to identify appropriate, supportive intervention content that is effective under ‘usual circumstances’ and also reaches the intended target population.īased on an efficacy trial and health promotion theory, staff in a Danish municipal health care center developed a type 2 diabetes preventive intervention “Live your life without diabetes”. However, changing and sustaining behaviour is complex, and the pathways for which intervention effects occur remain unclear. ![]() An efficacy trial showed that a weight loss > 5% at one-year was associated with prevention of type 2 diabetes at 3 years follow-up. Efficacy trials have shown that goal-orientated interventions that focused on changes in diet, physical activity and weight in high-risk individuals of type 2 diabetes, cut the risk of progression to type 2 diabetes in half. Physical activity and healthy diet are central factors for preventing several long-term diseases. ![]() Future studies should include possible interacting variables. Our study demonstrates an analytic approach for estimating mediating effects in complex interventions that comply with the criteria on temporal ordered data. We found no mediating effects of patient activation as a single variable of the intervention “Live your life without diabetes” on weight, waist circumference and systolic blood pressure at 12 months follow-up in adults at high risk of type 2 diabetes. Data for the present study was derived from questionnaires and clinical measures from baseline, three- and 12-months follow-up. The outcomes were weight, waist circumference and systolic blood pressure, and the mediator was patient activation, measured by the self-reported Patient Activation Measure (PAM). The intervention group received an empirical and theory-based intervention delivered over four two-h group sessions during five weeks, and two further sessions after one and six months. Participants were randomised to routine care ( n = 64), or intervention ( n = 63). The RCT took place in a Danish municipal healthcare center and included 127 individuals aged 28 to 70 years with fasting plasma glucose: 6.1–6.9 mmol/l and/or glycated haemoglobin (HbA 1c): 42.0–47.9 mmol/mol. MethodsĪutoregressive path models with three time points of measurement, and contemporaneous and constant b paths were used in a randomised controlled trial (RCT). Our aim was to assess the extent to which knowledge, skills and confidence to manage health, here measured as “patient activation”, was a mediator of the effect of the intervention “Live your life without diabetes” on weight, waist circumference and systolic blood pressure at 12 months follow-up in adults at high risk of type 2 diabetes. ![]() Exploring mediators of preventive intervention effects has important implications for the planning of complex interventions.
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