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.

"Declarations FundingThis work was supported by the Metabolic Fitness Association, Monterotondo, Rome, Italy. 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. Conflict of interest/Competing interestsAll 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. Ethics approvalThe study protocol was approved by the Ethics Committee of Sant’Andrea University Hospital (Prot. n. 212/2012) and was conducted in accordance with the Declaration of Helsinki. The participants provided written informed consent. Consent to participateParticipants provided written informed consent prior to participation. Consent for publicationNot applicable. Data availability statementThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Author contributionsAN 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. Conflict of interest/Competing interests 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."

"Funding Open access funding provided by Università degli Studi di Roma La Sapienza within the CRUI-CARE Agreement. Funding This work was supported by the Metabolic Fitness Association, Monterotondo, Rome, Italy. 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."

"Trial Registration ClinicalTrials.gov; NCT01600937; 10 October 2012."