The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle

Abstract

BackgroundPhysical 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/DesignStarting 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/m2, 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.DiscussionThe 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.Trial registrationClinicalTrials.gov; NCT01600937; 10 October 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-1088-0) contains supplementary material, which is available to authorized users.

Effect of a Behavioral Intervention Strategy for Adoption and Maintenance of a Physically Active Lifestyle: The Italian Diabetes and Exercise Study 2 (IDES_2)

“…The research protocol (24), which complies with the Declaration of Helsinki, was approved by the Sant'Andrea Hospital Ethics Committee (protocol no. 212/2012), and each participant provided written informed consent.…”

“…A specific strategy was implemented to train physicians (diabetologists) and exercise specialists (professionals holding a degree in exercise science) participating in the trial to standardize procedures and prevent clustering effect, improve efficacy and safety of the intervention and patient adherence, and minimize dropout, as previously detailed (24,25).…”

“…All patients consecutively attending these clinics were evaluated for eligibility on the grounds of medical history, clinical examination, and cardiologic evaluation (24).…”

“…The allocation sequence was generated at the Center for Outcomes Research and Clinical Epidemiology and was concealed until interventions were assigned (24).…”

“…; physical inactivity (i.e., insufficient amounts of PA according to current guidelines) and sedentary lifestyle (i.e., .8 h/day spent in any waking behavior characterized by an energy expenditure #1.5 METs while sitting or reclining) for at least 6 months; ability to walk 1.6 km without assistance; and eligibility after cardiologic evaluation (24).…”