Evidence map›Paper›PMID 26651484›Full record

Trial reportTrials2015

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

Stefano Balducci, Massimo Sacchetti, Jonida Haxhi, Giorgio Orlando, Silvano Zanuso, Patrizia Cardelli, Stefano Cavallo, Valeria D'Errico, Maria Cristina Ribaudo, Nicolina Di Biase and 7 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01600937 (Italian Diabetes and Exercise Study 2 - A Long-term Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01600937 nacompletednot on this map

Italian Diabetes and Exercise Study 2 - A Long-term Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle

TypeinterventionalSponsorMetabolic Fitness Association, ItalyRan2012 to 2017Enrolled300ConditionsType 2 DiabetesArmsTheoretical & practical exercise counseling
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Barriers and Facilitators for Physical Activity in Adults with Type 2 Diabetes Mellitus: A Scoping Review.International journal of environmental research and public health · 2021
    Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 7 institutions in 2 countries.

Stefano BalducciDepartment of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. sbalducci@esinet.it.
Massimo SacchettiDepartment of Human Movement and Sport Sciences, "Foro Italico" University, Rome, Italy. massimo.sacchetti@uniroma4.it.
Jonida HaxhiDiabetes Unit, Sant'Andrea Hospital, Rome, Italy. efijona@yahoo.com.
Giorgio OrlandoDepartment of Human Movement and Sport Sciences, "Foro Italico" University, Rome, Italy. orlando1986giorgio@libero.it.
Silvano ZanusoSchool of Science, University of Greenwich, London, UK. szanuso@gmail.com.
Patrizia CardelliDepartment of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. patrizia.cardelli@uniroma1.it.
Stefano CavalloDepartment of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. stefano.cavallo@uniroma1.it.
Valeria D'ErricoDiabetes Unit, Sant'Andrea Hospital, Rome, Italy. vale.derrico@hotmail.it.
Maria Cristina RibaudoDiabetes Unit, Sant'Andrea Hospital, Rome, Italy. mcribaudo@hotmail.com.
Nicolina Di BiaseDiabetes Unit, Fatebenefratelli San Pietro Hospital, Rome, Italy. nicgius@inwind.it.
Laura SalviDiabetes Unit, Sant'Andrea Hospital, Rome, Italy. laura.salvi@uniroma1.it.
Martina VitaleDiabetes Unit, Sant'Andrea Hospital, Rome, Italy. martina.vitale87@hotmail.it.
Lucilla BollantiDiabetes Unit, Sant'Andrea Hospital, Rome, Italy. lucillabollanti@libero.it.
Francesco G ContiDepartment of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. francesco.conti@uniroma1.it.
Antonio NicolucciCenter for Outcomes Research and Clinical Epidemiology (CORE), Pescara, Italy. nicolucci@coresearch.it.
Giuseppe PuglieseDepartment of Clinical and Molecular Medicine, "La Sapienza" University of Rome, Via di Grottarossa, 1035-1039 - 00189, Rome, Italy. giuseppe.pugliese@uniroma1.it.
Italian Diabetes and Exercise Study 2 (IDES_2) Investigators
CTO Andrea Alesini · ITForo Italico University of Rome · ITFatebenefratelli Hospital · ITOspedale San Giuseppe · ITSapienza University of Rome · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Greenwich · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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/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. 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 registrationClinicalTrials.gov; NCT01600937 ; 10 October 2012.

Indexed as

DietExerciseRisk Reduction BehaviorActigraphyBehavior TherapyCounselingDiabetes Mellitus, Type 2Exercise TestExercise ToleranceHealth BehaviorHumansMotor ActivityResearch DesignRisk FactorsRomeSedentary Behavior

Identifiers

PMID26651484
PMCPMC4676117
OpenAlexW2192666975

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.