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Randomized Controlled Trial
. 2022 Mar;52(3):643-654.
doi: 10.1007/s40279-021-01556-0. Epub 2021 Oct 1.

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

Antonio Nicolucci #  1   2 , Jonida Haxhi #  3   4   5 , Valeria D'Errico  3   4   5 , Massimo Sacchetti  6 , Giorgio Orlando  6   7 , Patrizia Cardelli  3   8 , Martina Vitale  3   4 , Lucilla Bollanti  3   4 , Francesco Conti  3   4 , Silvano Zanuso  9   10 , Giuseppe Lucisano  1   2 , Stefano Balducci  3   4   5 , Giuseppe Pugliese  11   12 ; Italian Diabetes and Exercise Study 2 (IDES_2) Investigators
Collaborators, Affiliations
Randomized Controlled Trial

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

Antonio Nicolucci et al. Sports Med. 2022 Mar.

Abstract

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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Conflict of interest statement

All authors have completed and submitted the Conflicts of Interest Disclosure form. Antonio Nicolucci reported grants from Artsana, Astra-Zeneca, Eli Lilly, Novo Nordisk and Sanofi Aventis and personal fees from Eli Lilly and Novo Nordisk; Silvano Zanuso is an employee of Technogym; Stefano Balducci reported personal fees from Astra-Zeneca, Eli Lilly, Novo Nordisk and Takeda; Giuseppe Pugliese reported personal fees from Astra-Zeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp & Dome, Mylan, Sigma-Tau and Takeda; no other disclosures were reported.

Figures

Fig. 1
Fig. 1
Study flow chart. Flow of participants through the study. CON control group, INT intervention group, F females, M males
Fig. 2
Fig. 2
WHO-5, PCS and MCS scores over time. Change over time in WHO-5 (a), PCS (b) and MCS (c) scores in participants in the INT (black boxes) versus CON (white boxes) group. Data [estimated mean with 95% confidence interval (CI)] were calculated on the basis of questionnaires filled in at scheduled visits. The analyses are based on a mixed model for repeated measurements, taking into account within-participant correlation. P values were calculated with a mixed model for repeated measurements. Estimated mean differences over time with 95% CIs and P values between INT and CON are reported at the top right. WHO World Health Organization, PCS physical component summary, MCS mental component summary, CON control group, INT intervention group
Fig. 3
Fig. 3
WHO-5 scores over time by physically active status. Change over time in WHO-5 scores in participants accumulating (black boxes) and not accumulating (white boxes) 150 min·wk−1 of MVPA. Data (estimated mean with 95% CI) were calculated on the basis of questionnaires filled in at scheduled visits. The analyses are based on a mixed model for repeated measurements, taking into account within-participant correlation. P values were calculated with a mixed model for repeated measurements. Estimated mean differences over time with 95% CIs and P values between INT and CON are reported at the top right. WHO World Health Organization, CON control group, INT intervention group
Fig. 4
Fig. 4
Physical and mental domain scores over time. Change over time in SF-36 scores in physical functioning (a), limitation physical (b), bodily pain (c), general health (d), emotional/mental health (e), limitation emotional (f), social functioning (g) and energy/vitality (h) in participants in the INT (black boxes) versus CON (white boxes) group. Data [estimated mean with 95% confidence interval (CI)] were calculated on the basis of questionnaires filled in at scheduled visits. The analyses are based on a mixed model for repeated measurements, taking into account within-participant correlation. P values were calculated with a mixed model for repeated measurements. Estimated mean differences over time with 95% CIs and P values between INT and CON are reported at the top right. SF-36 36-Item Short Form, CON control group, INT intervention group
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