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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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>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\u201311.55), <jats:italic>P<\/jats:italic>\u2009=\u20090.0007; PCS 4.20 (95% CI 2.25\u20136.15), <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001; MCS 3.04 (95% CI 1.09\u20134.99), <jats:italic>P<\/jats:italic>\u2009=\u20090.0025). 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\u2009&gt;\u2009150\u00a0min\u00b7wk<jats:sup>\u22121<\/jats:sup> of moderate-to-vigorous intensity PA versus those who did not (13.06 (95% CI 7.51\u201318.61), <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001), whereas no relationship was detected for QoL.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>A counselling intervention that was effective in promoting a sustained change in PA and sedentary behaviour significantly improved psychological well-being and QoL.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial Registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov; NCT01600937; 10 October 2012.<\/jats:p>\n              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The sponsor had no role in the design and conduct of the study; collection, management and interpretation of the data; or preparation, review or approval of the manuscript, and decision to submit for publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"All authors have completed and submitted the Conflicts of Interest Disclosure form. Antonio Nicolucci reported grants from Artsana, Astra-Zeneca, Eli Lilly, Novo Nordisk and Sanofi Aventis and personal fees from Eli Lilly and Novo Nordisk; Silvano Zanuso is an employee of Technogym; Stefano Balducci reported personal fees from Astra-Zeneca, Eli Lilly, Novo Nordisk and Takeda; Giuseppe Pugliese reported personal fees from Astra-Zeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dome, Mylan, Sigma-Tau and Takeda; no other disclosures were reported.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest\/Competing interests"}},{"value":"The study protocol was approved by the Ethics Committee of Sant\u2019Andrea University Hospital (Prot. n. 212\/2012) and was conducted in accordance with the Declaration of Helsinki. The participants provided written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Participants provided written informed consent prior to participation.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets generated during and\/or analysed during the current study are available from the corresponding author on reasonable request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data availability statement"}},{"value":"AN conceived and designed the study, performed statistical analysis, and reviewed\/edited the manuscript; JH conceived and designed the study, researched data and drafted the manuscript; VDE, MS, GO, PC, MV, LB, FC and SZ researched data and contributed to the discussion; GL performed statistical analysis and contributed to the discussion; SB conceived and designed the study, researched data, and reviewed\/edited the manuscript; GP conceived and designed the study, researched data and drafted the manuscript. All authors read and approved the final manuscript.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}