Well-Being Therapy and Lifestyle Intervention in Type 2 Diabetes: A Pilot Randomized Controlled Trial

Abstract

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.

Behavioral Lifestyle Interventions for Weight Loss in Overweight or Obese Patients with Type 2 Diabetes: A Systematic Review of the Literature

“…All studies were randomized controlled trials (RCTs). Among the RCTs identified, three were feasibility trials [ 29 , 30 , 31 •] and three pilot studies [ 32 – 34 ]. Most studies adopted a two-group design, except for 4 studies, which adopted a three-group design [ 29 , 30 , 33 , 34 ].…”

“…Ten studies [ 37 – 43 , 44 ••, 45 , 46 ] belonged to the Look AHEAD trial. Besides the Look AHEAD trial, seven additional studies compared a behavioral lifestyle intervention vs. usual care control group [ 31 •, 33 , 34 , 47 – 49 , 50 ••, 51 , ] and a no-treatment control group [ 52 ]. Five studies compared interventions consisting of different behavioral techniques associated with specific diets [ 32 , 53 – 57 , 58 ••], and 2 studies compared behavioral lifestyle intervention vs usual care in subgroups of ethnic minorities [ 36 , 38 ].…”

“…Studies included a follow-up evaluation ranging from 1 month to almost 10 years after the end of the intervention. Excluding the Look AHEAD studies [ 38 – 43 , 44 ••, 45 , 46 ], which included the longest follow-ups, other research involved follow-up of 1 month [ 36 ], 6 months [ 29 , 31 •, 35 •, 49 ], 12 months [ 31 •, 47 , 48 ], and 48 months [ 48 ].…”

Predictors of Mental Health Outcomes in a Multidisciplinary Weight Management Program for Class 3 Obesity

“…The scores were then summed to obtain a total score between 10 and 50, where higher scores indicate higher levels of psychological distress [57]. The total score indicates the levels of psychological distress as follows: low (10-15), moderate (16)(17)(18)(19)(20)(21), high (22-29), and very high (30-50) [58]. In this sample, Cronbach's alpha (α) for the item pool of K10 score was 0.93 at baseline and 0.94 at 12-month follow-up.…”

“…The psychological outcomes of weight management programs (WMPs) have primarily focused on changes in depression, anxiety, and health-related quality of life. Improvements in mood have been found in a number of randomised controlled trials following WMPs compared to active (intervention) [20][21][22][23][24] or non-active (waitlist or treatment as usual) comparator groups [20,25,26]. While some studies reported no significant improvement in depression in the short term, these could be attributable to the online mode of delivery [27,28] due to the nature of the study design and insufficient treatment doses [28,29].…”