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Well-Being Therapy and Lifestyle Intervention in Type 2 Diabetes: A Pilot Randomized Controlled Trial
Giada Benasi1, Sara Gostoli, Boheng Zhu
1From the Department of Medicine, Division of General Medicine (Benasi), Columbia University Irving Medical Center, New York City, New York; Department of Psychology "Renzo Canestrari"(Benasi, Gostoli, Zhu, Rafanelli), University of Bologna, Bologna, Italy; Department of Psychological Medicine, Peking Union Medical College Hospital (Zhu), Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Medicine (Offidani), Weill Cornell Medical College, New York City, New York; Vagelos College of Physicians and Surgeons (Artin), Columbia University Irving Medical Center, New York City, New York; Endocrinologia e Malattie Metaboliche (Gagliardi), Ospedale Maurizio Bufalini, Cesena, Italy; Endocrinologia, Azienda Ospedaliera di Cremona (Rignanese, Sassi), Ospedale Oglio Po, Casalmaggiore CR, Italy; and Department of Psychiatry, University at Buffalo (Fava), State University of New York, Buffalo, New York.
Objective:
This pilot randomized controlled trial evaluates the preliminary efficacy of a 4-month well-being therapy (WBT) and lifestyle intervention among adults with type 2 diabetes and overweight/obesity.
Methods:
Fifty-eight patients were recruited from two outpatient clinics and randomized to receive the WBT-lifestyle intervention or the lifestyle intervention alone. Data were collected at baseline (T0), immediate postintervention (T1), 6-month follow-up (T2), and 12-month follow-up (T3). Primary efficacy outcomes included changes in weight, psychological distress, and well-being, whereas secondary efficacy outcomes included changes in lifestyle and physiological parameters.
Results:
Compared with the lifestyle-alone intervention, the WBT-lifestyle intervention showed greater improvements in depression (p = .009, d = -0.6), hostility (p = .018, d = -0.6), and personal growth (p = .026, d = 0.5) at T1, in self-reported physical activity at T2 (p = .013, d = 0.7) and T3 (p = .040, d = 0.5), and in triglycerides (p = .019, d = -1.12) at T3. There were no differences between treatment groups in weight and other physiological parameters.
Conclusions:
These findings suggest that WBT may be a valuable addition to lifestyle interventions for improving short-term psychological outcomes and promoting long-term healthy changes in physical activity, with a potential impact on physiological outcomes.Trial Registration:ClinicalTrials.gov identifier: NCT03609463.
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