Effect of a Behavioral Intervention Strategy on Sustained Change in Physical Activity and Sedentary Behavior in Patients With Type 2 Diabetes: The IDES_2 Randomized Clinical Trial
Open accessAbstract
Importance: There is no definitive evidence that changes in physical activity/sedentary behavior can be maintained long term in individuals with type 2 diabetes. Objective: To investigate whether a behavioral intervention strategy can produce a sustained increase in physical activity and reduction in sedentary time among individuals with type 2 diabetes. Design, Setting, and Participants: The Italian Diabetes and Exercise Study 2 was an open-label, assessor-blinded, randomized clinical superiority trial, with recruitment from October 2012 to February 2014 and follow-up until February 2017. In 3 outpatient diabetes clinics in Rome, 300 physically inactive and sedentary patients with type 2 diabetes were randomized 1:1 (stratified by center, age, and diabetes treatment) to receive a behavioral intervention or standard care for 3 years. Interventions: All participants received usual care targeted to meet American Diabetes Association guideline recommendations. Participants in the behavioral intervention group (n = 150) received 1 individual theoretical counseling session and 8 individual biweekly theoretical and practical counseling sessions each year. Participants in the standard care group (n = 150) received only general physician recommendations. Main Outcomes and Measures: Co-primary end points were sustained change in physical activity volume, time spent in light-intensity and moderate- to vigorous-intensity physical activity, and sedentary time, measured by an accelerometer. Results: Of the 300 randomized participants (mean [SD] age, 61.6 [8.5] years; 116 women [38.7%]), 267 completed the study (133 in the behavioral intervention group and 134 in the standard care group). Median follow-up was 3.0 years. Participants in the behavioral intervention and standard care groups accumulated, respectively, 13.8 vs 10.5 metabolic equivalent-h/wk of physical activity volume (difference, 3.3 [95% CI, 2.2-4.4]; P < .001), 18.9 vs 12.5 min/dof moderate- to vigorous-intensity physical activity (difference, 6.4 [95% CI, 5.0-7.8]; P < .001), 4.6 vs 3.8 h/d of light-intensity physical activity (difference, 0.8 [95% CI, 0.5-1.1]; P < .001), and 10.9 vs 11.7 h/d of sedentary time (difference, -0.8 [95% CI, -1.0 to -0.5]; P < .001). Significant between-group differences were maintained throughout the study, but the between-group difference in moderate- to vigorous-intensity physical activity decreased during the third year from 6.5 to 3.6 min/d. There were 41 adverse events in the behavioral intervention group and 59 in the standard care group outside of the sessions; participants in the behavioral intervention group experienced 30 adverse events during the sessions (most commonly musculoskeletal injury/discomfort and mild hypoglycemia). Conclusions and Relevance: Among patients with type 2 diabetes at 3 diabetes clinics in Rome who were followed up for 3 years, a behavioral intervention strategy compared with standard care resulted in a sustained increase in physical activity and decrease in sedentary time. Further research is needed to assess the generalizability of these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT01600937.
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Patients can be motivated by motivational interviewing including the OARS and SMART principles.
“Patients can be motivated by motivational interviewing including the Open-ended questions, Affirmation, Reflective listening, and Summarizing (OARS) and Specific, Measurable, Achievable, Realistic, Timely (SMART) principles.”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [372]
Perceived susceptibility to illness and the anticipated severity of the consequences are prominent components of patients' motivation.
“Perceived susceptibility to illness and the anticipated severity of the consequences are also prominent components of patients' motivation.372”
From 2023 ESC guidelines for the management of cardiovascular disease in patients with diabetes. (2023) · cites this paper as [372]
In IDES_2, behavioral counseling promoted a sustained increase in light-intensity physical activity of 0.8 h/day.
“and light-intensity PA (LPA) (+0.8 h Á day 21 )”
In IDES_2, behavioral counseling promoted a sustained decrease in sedentary time of 0.8 h/day.
“and decrease in sedentary time (SEDtime) (20.8 h Á day 21 )”
In IDES_2, the reduction in SED-time and the reciprocal increment in LPA in comparisons with standard care were 0.8 h/day over time.
“the reduction in SED-time and the reciprocal increment in time spent in LPA in comparisons with individuals receiving standard care were 0.8 h Á day À1 over time”
In IDES_2, behavioral counseling promoted a sustained increase in moderate-to-vigorous-intensity physical activity of 6.4 min/day.
“moderate-to vigorous-intensity PA (MVPA) (+6.4 min Á day 21 )”
In IDES_2, behavioral counseling promoted a sustained increase in physical activity volume of 3.3 MET h/week.
“In the Italian Diabetes and Exercise Study_2 (IDES_2), behavioral counseling promoted a sustained increase in physical activity (PA) volume (+3.3 MET h Á week 21 )”
In IDES_2, the increase versus control in MVPA was only 6.4 min/day during the 3-year period and 3.6 min/day at the end of the study.
“However, while the increase versus control in MVPA was only 6.4 min Á day À1 during the 3-year period and 3.6 min Á day À1 at the end of the study”
In IDES_2, a counseling intervention targeting both PA and sedentary behavior resulted in clinically meaningful improvements in physical fitness and, to a lesser extent, in CVD risk factors and scores over a 3-year follow-up.
“Conversely, in the Italian Diabetes and Exercise Study 2 (IDES_2), a counseling intervention targeting both PA and sedentary behavior, which was effective in promoting a sustained increase in PA and decrease in SED-time, resulted in clinically meaningful improvements in physical fitness and, to a lesser extent, in CVD risk factors and scores over a 3-year follow-up (13).”
In IDES_2, the increase in LPA substantially contributed to the 3.3 MET h/week increase in total PA volume.
“with the increase in LPA substantially contributing to the 3.3 MET h Á week À1 increase in total PA volume”
In IDES_2, time spent in MVPA was only ~12 min/day at baseline and increased by >50% throughout the 3-year follow-up, remaining 30% over baseline at end of study.
“In fact, in the IDES_2, time spent in MVPA was only $12 min Á day À1 at baseline and, hence, increased by >50% throughout the 3-year follow-up and was still 30% over baseline at end of study (13).”
The relative extent of increases over baseline in MVPA is as relevant as the absolute increase for the effect on clinical outcomes.
“Another plausible, not mutually exclusive explanation for the discrepancies between the IDES_2 and walking-based intervention studies is that the relative extent of increases over baseline in MVPA is as relevant as the absolute increase for the effect on clinical outcomes.”
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- Authors
- Balducci, S., D’Errico, V., Haxhi, J., Sacchetti, M., Orlando, G., Cardelli, P., Vitale, M., Bollanti, L., Conti, F., Zanuso, S., Lucisano, G., Nicolucci, A., Pugliese, G., & for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators
- Affiliations
- Azienda Ospedaliera Sant'Andrea (IT)
- Foro Italico University of Rome (IT)
- Coventry (United Kingdom) (GB)
- Mario Negri Sud Foundation (IT)
- Corresponding author
- Pugliese, Giuseppe
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2019-03-05
- Volume
- 321
- Issue
- 9
- Pages
- 880
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- OpenAlex
- W2919725708
- Cited by
- 158
- References
- 46
- Citations by year
- 2026: 11 · 2025: 21 · 2024: 17 · 2023: 24 · 2022: 20 · 2021: 39 · 2020: 19 · 2019: 6
- FWCI
- 14.45
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- Topics
- Health Sciences › Medicine › Physiology › Physical Activity and Health
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Social Sciences › Psychology › Applied Psychology › Behavioral Health and Interventions
- Keywords
- type 2 diabetes, behavioral interventions, physical activity, sedentary behavior, sustained change, moderate-to-vigorous physical activity, light physical activity, individual counseling, accelerometer-measured activity, physical inactivity, outpatient diabetes care, physician recommendations, diabetes self-management education
- MeSH terms
- Aged, Behavior Therapy, Counseling, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Humans, Male, Middle Aged, Rome, Exercise, Single-Blind Method, Sedentary Behavior, Accelerometry
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