Effect of a Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle on Psychological Well-Being and Quality of Life in Patients with Type 2 Diabetes: The IDES_2 Randomized Clinical Trial
Antonio Nicolucci, Jonida Haxhi, Valeria D’Errico, Massimo Sacchetti, Giorgio Orlando, Patrizia Cardelli, Martina Vitale, Lucilla Bollanti, F. Conti, Silvano Zanuso, Giuseppe Lucisano, Stefano Balducci, Giuseppe Pugliese, for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators, Giuseppe Pugliese, Stefano Balducci, Massimo Sacchetti, Silvano Zanuso, Patrizia Cardelli, Antonio Nicolucci, Giuseppe Pugliese, Mária Cristina Ribaudo, Elena Alessi, Martina Vitale, Tiziana Cirrito, Lucilla Bollanti, Nicolina Di Biase, Filomena La Saracina, Stefano Balducci, Mario Ranuzzi Jonida Haxhi, Valeria D’Errico, Massimo Sacchetti, Giorgio Orlando, Luca Milo, Roberto Milo, Gianluca Balducci, Enza Spinelli
Abstract
Abstract Background Psychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change. Objective This study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and health-related QoL in individuals with type 2 diabetes. Methods Three hundred physically inactive and sedentary patients were randomized 1:1 to receive 1 month’s theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON) for 3 years. Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire, respectively, were pre-specified secondary endpoints. The primary endpoint was sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time. Results WHO-5 and SF-36 physical and mental component summary (PCS and MCS) scores increased progressively in the INT group and decreased in the CON group, resulting in significant between-group differences (WHO-5: mean difference 7.35 (95% confidence interval (CI) 3.15–11.55), P = 0.0007; PCS 4.20 (95% CI 2.25–6.15), P < 0.0001; MCS 3.04 (95% CI 1.09–4.99), P = 0.0025). Percentage of participants with likely depression decreased in the INT group and increased in the CON group. PA volume changes were independently associated with WHO-5 changes, which were significantly higher in participants who accumulated > 150 min·wk −1 of moderate-to-vigorous intensity PA versus those who did not (13.06 (95% CI 7.51–18.61), P < 0.0001), whereas no relationship was detected for QoL. Conclusion A counselling intervention that was effective in promoting a sustained change in PA and sedentary behaviour significantly improved psychological well-being and QoL. Trial Registration ClinicalTrials.gov; NCT01600937; 10 October 2012.