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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Stefano Balducci, Massimo Sacchetti, Jonida Haxhi, Giorgio Orlando, Silvano Zanuso, Patrizia Cardelli, Stefano Cavallo, Valeria D’Errico, Maria Cristina Ribaudo, Nicolina Di Biase, Laura Salvi, Martina Vitale, Lucilla Bollanti, Francesco G. Conti, Antonio Nicolucci, Giuseppe Pugliese, for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators

Published in: Trials | Issue 1/2015

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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/Design

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/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.

Discussion

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.

Trial registration

ClinicalTrials.gov; NCT01600937; 10 October 2012.
Appendix
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Metadata
Title
The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle
Authors
Stefano Balducci
Massimo Sacchetti
Jonida Haxhi
Giorgio Orlando
Silvano Zanuso
Patrizia Cardelli
Stefano Cavallo
Valeria D’Errico
Maria Cristina Ribaudo
Nicolina Di Biase
Laura Salvi
Martina Vitale
Lucilla Bollanti
Francesco G. Conti
Antonio Nicolucci
Giuseppe Pugliese
for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-1088-0

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