Effect of a Behavioural Intervention for Adoption and Maintenance of a Physically Active Lifestyle on Psychological Well-Being and Quality of Life in Patients with Type 2 Diabetes: The IDES_2 Randomized Clinical Trial
Open accessAbstract
Background: Psychological well-being and quality of life (QoL) are important outcomes of lifestyle interventions, as a positive impact may favour long-term maintenance of behaviour change. Objective: This study investigated the effect of a behavioural intervention for adopting and maintaining an active lifestyle on psychological well-being and health-related QoL in individuals with type 2 diabetes. Methods: Three hundred physically inactive and sedentary patients were randomized 1:1 to receive 1 month’s theoretical and practical counselling once a year (intervention group, INT) or standard care (control group, CON) for 3 years. Psychological well-being and QoL, assessed using the World Health Organization (WHO)-5 and the 36-Item Short Form (SF-36) questionnaire, respectively, were pre-specified secondary endpoints. The primary endpoint was sustained behaviour change, as assessed by accelerometer-based measurement of physical activity (PA) and sedentary time. Results: WHO-5 and SF-36 physical and mental component summary (PCS and MCS) scores increased progressively in the INT group and decreased in the CON group, resulting in significant between-group differences (WHO-5: mean difference 7.35 (95% confidence interval (CI) 3.15–11.55), P = 0.0007; PCS 4.20 (95% CI 2.25–6.15), P < 0.0001; MCS 3.04 (95% CI 1.09–4.99), P = 0.0025). Percentage of participants with likely depression decreased in the INT group and increased in the CON group. PA volume changes were independently associated with WHO-5 changes, which were significantly higher in participants who accumulated > 150 min·wk−1 of moderate-to-vigorous intensity PA versus those who did not (13.06 (95% CI 7.51–18.61), P < 0.0001), whereas no relationship was detected for QoL. Conclusion: A counselling intervention that was effective in promoting a sustained change in PA and sedentary behaviour significantly improved psychological well-being and QoL. Trial Registration: ClinicalTrials.gov; NCT01600937; 10 October 2012.
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Improvements in all lifestyle domains targeted are associated with improvements in the QOL mental component summary measure.
“This is aligned with evidence showing that improvements in all lifestyle domains that we targeted is associated with improvements in the QOL mental component summary measure [5, 6, 70, 81, 82].”
From Personalized machine learning guided intervention for optimizing lifestyle behaviors in depression: a pilot study (2026) · cites this paper as [81]
The Results (QoL; page unavailable) report improved mental component summary (MCS) scores in the intervention group. But the Discussion (Predictors of Well-Being/QoL Changes; page unavailable) says changes in physical activity and sedentary behaviour were not related to quality-of-life changes. The paper therefore does not support the claimed association between improvements across all targeted lifestyle domains and MCS improvement. (LLM, conf=0.87)
Experimental — accuracy not yet measuredHealth behavior change strategies may be delivered by mental health professionals, DCES, other trained health care professionals, or qualified community health workers.
“Health behavior change strategies may be delivered by mental health professionals, DCES, or other trained health care professionals (307,312-314) or qualified community health workers (307,308).”
From 5. Facilitating Positive Health Behaviors and Well-being to Improve Health Outcomes:<i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [312]
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ElSayed, N. A., Aleppo, G., Aroda, V. R., Bannuru, R. R., Brown, F. M., Bruemmer, D., Collins, B. S., Hilliard, M. E., Isaacs, D., Johnson, E. L., et al. (2023) · Diabetes Care · doi:10.2337/dc23-s005 · Cited by 362 · see citing works
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“This is aligned with evidence showing that improvements in all lifestyle domains that we targeted is associated with improvements in the QOL mental component summary measure [5, 6, 70, 81, 82].”
- Authors
- Nicolucci, A., Haxhi, J., D’Errico, V., Sacchetti, M., Orlando, G., Cardelli, P., Vitale, M., Bollanti, L., Conti, F., Zanuso, S., Lucisano, G., Balducci, S., Pugliese, G., for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators, Pugliese, G., Balducci, S., Sacchetti, M., Zanuso, S., Cardelli, P., Nicolucci, A., Pugliese, G., Ribaudo, M. C., Alessi, E., Vitale, M., Cirrito, T., Bollanti, L., Di Biase, N., La Saracina, F., Balducci, S., Haxhi, M. R. J., D’Errico, V., Sacchetti, M., Orlando, G., Milo, L., Milo, R., Balducci, G., & Spinelli, E.
- Affiliations
- Azienda Ospedaliera Sant'Andrea (IT)
- Mario Negri Sud Foundation (IT)
- Associazione Fitness Metabolica O.N.L.U.S. (IT)
- Venue
- Sports Medicine
- Published
- 2021-10-01
- Volume
- 52
- Issue
- 3
- Pages
- 643-654
- ISSN
- 0112-1642 (ISSN-L)
- 1179-2035
- PMC
- PMC8891112
- OpenAlex
- W3204342752
- Cited by
- 19
- References
- 41
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 6 · 2023: 1 · 2022: 4
- FWCI
- 1.73
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Sports Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- e-space (Manchester Metropolitan University) (acceptedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion, cc-by)
- Figshare (submittedVersion, cc-by)
- Funders
- metabolic fitness association
- Università degli Studi di Roma La Sapienza
- 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, physical activity, sedentary behavior, behavioral interventions, psychological well-being, quality of life, depression, counseling, behavior maintenance, moderate-to-vigorous physical activity, WHO-5, SF-36
- MeSH terms
- Diabetes Mellitus, Type 2, Humans, Life Style, Quality of Life, Exercise, Sedentary Behavior
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