title: The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle.
abstract: BACKGROUND
  Physical activity (PA)/exercise have become an integral part of the management of type 2 diabetes mellitus (T2DM). However, current guidelines are difficult to put into action in this population due to a number of barriers, especially the lack of acceptable, feasible, and validated behavioral intervention strategies. The present manuscript reports the rationale, study design and methods, and design considerations of the Italian Diabetes and Exercise Study (IDES)-2, a randomized controlled trial testing the efficacy of a behavior change strategy in increasing total daily PA and reducing sedentary time (SED-time) in patients with T2DM.
  
  
  METHODS
  Starting 7 January 2014, the IDES_2 began enrolling 300 patients with known T2DM of at least 1-year duration in three tertiary referral outpatient Diabetes Clinics in Rome. Additional requirements are age 40 to 80 years, body mass index 27 to 40 kg/m(2), sedentary lifestyle, and physically inactive for at least 6 months, ability to walk 1.6 km without assistance, and eligibility after cardiovascular evaluation. Patients are randomized by center and within each center, by age and type of diabetes treatment to either the intervention or the control group. Patients in the intervention (INT) group (n = 150) receive theoretical and practical exercise counseling consisting of aggregated behavior change techniques (one individual theoretical counseling session plus eight twice-a-week individual theoretical and practical exercise counseling sessions) once a year for 3 years. Patients in the control (CON) group (n = 150), receive standard care, including general physician recommendations for daily PA. The primary outcomes are total daily PA and SED-time, as measured objectively by the use of an accelerometer. Secondary outcomes include physical fitness, modifiable cardiovascular risk factors, musculoskeletal disturbances, well-being/depression, and health-related quality of life.
  
  
  CONCLUSIONS
  The behavioral intervention strategy tested in the IDES_2 is based on solid theoretical grounds and uses several behavioral change techniques, two factors which were found to improve effectiveness of behavioral intervention. In addition, physicians and exercise specialists have been specifically trained for counselling/prescribing and supervising PA/exercise, respectively, in subjects suffering from metabolic disorders. Finally, the large sample size, the long study duration, and the objective measurement of PA allow statistically significant and scientifically robust conclusions to be drawn on the feasibility and efficacy of this intervention in T2DM patients.
  
  
  BACKGROUND
  ClinicalTrials.gov; NCT01600937 ; 10 October 2012.
authors.affiliation: Department of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. sbalducci@esinet.it.|Diabetes Unit, Sant'Andrea Hospital, Rome, Italy. sbalducci@esinet.it.|Metabolic Fitness Association, Monterotondo, Rome, Italy. sbalducci@esinet.it.
authors.forename: Stefano
authors.initials: S
authors.lastname: Balducci
authors.affiliation: Department of Human Movement and Sport Sciences, "Foro Italico" University, Rome, Italy. massimo.sacchetti@uniroma4.it.
authors.forename: Massimo
authors.initials: M
authors.lastname: Sacchetti
authors.affiliation: Diabetes Unit, Sant'Andrea Hospital, Rome, Italy. efijona@yahoo.com.|Metabolic Fitness Association, Monterotondo, Rome, Italy. efijona@yahoo.com.|Department of Human Movement and Sport Sciences, "Foro Italico" University, Rome, Italy. efijona@yahoo.com.
authors.forename: Jonida
authors.initials: J
authors.lastname: Haxhi
authors.affiliation: Department of Human Movement and Sport Sciences, "Foro Italico" University, Rome, Italy. orlando1986giorgio@libero.it.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Orlando
authors.affiliation: School of Science, University of Greenwich, London, UK. szanuso@gmail.com.
authors.forename: Silvano
authors.initials: S
authors.lastname: Zanuso
authors.affiliation: Department of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. patrizia.cardelli@uniroma1.it.|Laboratory of Clinical Chemistry, Sant'Andrea Hospital, Rome, Italy. patrizia.cardelli@uniroma1.it.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Cardelli
authors.affiliation: Department of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. stefano.cavallo@uniroma1.it.|Laboratory of Clinical Chemistry, Sant'Andrea Hospital, Rome, Italy. stefano.cavallo@uniroma1.it.
authors.forename: Stefano
authors.initials: S
authors.lastname: Cavallo
authors.affiliation: Diabetes Unit, Sant'Andrea Hospital, Rome, Italy. vale.derrico@hotmail.it.|Metabolic Fitness Association, Monterotondo, Rome, Italy. vale.derrico@hotmail.it.
authors.forename: Valeria
authors.initials: V
authors.lastname: D'Errico
authors.affiliation: Diabetes Unit, Sant'Andrea Hospital, Rome, Italy. mcribaudo@hotmail.com.
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Ribaudo
authors.affiliation: Diabetes Unit, Fatebenefratelli San Pietro Hospital, Rome, Italy. nicgius@inwind.it.
authors.forename: Nicolina
authors.initials: N
authors.lastname: Di Biase
authors.affiliation: Diabetes Unit, Sant'Andrea Hospital, Rome, Italy. laura.salvi@uniroma1.it.
authors.forename: Laura
authors.initials: L
authors.lastname: Salvi
authors.affiliation: Diabetes Unit, Sant'Andrea Hospital, Rome, Italy. martina.vitale87@hotmail.it.
authors.forename: Martina
authors.initials: M
authors.lastname: Vitale
authors.affiliation: Diabetes Unit, Sant'Andrea Hospital, Rome, Italy. lucillabollanti@libero.it.
authors.forename: Lucilla
authors.initials: L
authors.lastname: Bollanti
authors.affiliation: Department of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. francesco.conti@uniroma1.it.|Diabetes Unit, Sant'Andrea Hospital, Rome, Italy. francesco.conti@uniroma1.it.
authors.forename: Francesco G
authors.initials: FG
authors.lastname: Conti
authors.affiliation: Center for Outcomes Research and Clinical Epidemiology (CORE), Pescara, Italy. nicolucci@coresearch.it.
authors.forename: Antonio
authors.initials: A
authors.lastname: Nicolucci
authors.affiliation: Department of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. giuseppe.pugliese@uniroma1.it.|Diabetes Unit, Sant'Andrea Hospital, Rome, Italy. giuseppe.pugliese@uniroma1.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Pugliese
mesh_terms: D056044:Actigraphy / Q000295:instrumentation; D001521:Behavior Therapy / Q000379:methods*; D003376:Counseling; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D004032:Diet / Q000009:adverse effects; D015444:Exercise; D005080:Exercise Test; D017079:Exercise Tolerance; D015438:Health Behavior; D006801:Humans; D009043:Motor Activity; D012107:Research Design; D012307:Risk Factors; D040242:Risk Reduction Behavior; D012384:Rome; D057185:Sedentary Behavior; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome