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

Nicolucci, A ORCID: https://orcid.org/0000-0002-5939-6850, Haxhi, J ORCID: https://orcid.org/0000-0003-2319-869X, D’Errico, V, Sacchetti, M ORCID: https://orcid.org/0000-0002-5365-5161, Orlando, G ORCID: https://orcid.org/0000-0001-6721-8248, Cardelli, P, Vitale, M ORCID: https://orcid.org/0000-0003-4856-7279, Bollanti, L, Conti, F ORCID: https://orcid.org/0000-0002-9446-6594, Zanuso, S ORCID: https://orcid.org/0000-0002-8187-5815, Lucisano, G, Balducci, S ORCID: https://orcid.org/0000-0001-8128-3863, Pugliese, G ORCID: https://orcid.org/0000-0003-1574-0397, Pugliese, G, Ribaudo, MC, Alessi, E, Cirrito, T, Di Biase, N, La Saracina, F, Haxhi, MRJ, Milo, L, Milo, R, Balducci, G and Spinelli, E (2022) 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. Sports Medicine, 52 (3). pp. 643-654. ISSN 0112-1642

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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.