Multidimensional Cognitive Behavioral Therapy for Obesity Applied by Psychologists Using a Digital Platform: Open-Label Randomized Controlled Trial

Abstract

Background Developing effective, widely useful, weight management programs is a priority in health care because obesity is a major health problem. Objective This study developed and investigated a new, comprehensive, multifactorial, daily, intensive, psychologist coaching program based on cognitive behavioral therapy (CBT) modules. The program was delivered via the digital health care mobile services Noom Coach and InBody. Methods This was an open-label, active-comparator, randomized controlled trial. A total of 70 female participants with BMI scores above 24 kg/m2 and no clinical problems besides obesity were randomized into experimental and control groups. The experimental (ie, digital CBT) group (n=45) was connected with a therapist intervention using a digital health care service that provided daily feedback and assignments for 8 weeks. The control group (n=25) also used the digital health care service, but practiced self-care without therapist intervention. The main outcomes of this study were measured objectively at baseline, 8 weeks, and 24 weeks and included weight (kg) as well as other body compositions. Differences between groups were evaluated using independent t tests and a per-protocol framework. Results Mean weight loss at 8 weeks in the digital CBT group was significantly higher than in the control group (–3.1%, SD 4.5, vs –0.7%, SD 3.4, P=.04). Additionally, the proportion of subjects who attained conventional 5% weight loss from baseline in the digital CBT group was significantly higher than in the control group at 8 weeks (32% [12/38] vs 4% [1/21], P=.02) but not at 24 weeks. Mean fat mass reduction in the digital CBT group at 8 weeks was also significantly greater than in the control group (–6.3%, SD 8.8, vs –0.8%, SD 8.1, P=.02). Mean leptin and insulin resistance in the digital CBT group at 8 weeks was significantly reduced compared to the control group (–15.8%, SD 29.9, vs 7.2%, SD 35.9, P=.01; and –7.1%, SD 35.1, vs 14.4%, SD 41.2, P=.04). Emotional eating behavior (ie, mean score) measured by questionnaire (ie, the Dutch Eating Behavior Questionnaire) at 8 weeks was significantly improved compared to the control group (–2.8%, SD 34.4, vs 21.6%, SD 56.9, P=.048). Mean snack calorie intake in the digital CBT group during the intervention period was significantly lower than in the control group (135.9 kcal, SD 86.4, vs 208.2 kcal, SD 166.3, P=.02). Lastly, baseline depression, anxiety, and self-esteem levels significantly predicted long-term clinical outcomes (24 weeks), while baseline motivation significantly predicted both short-term (8 weeks) and long-term clinical outcomes. Conclusions These findings confirm that technology-based interventions should be multidimensional and are most effective with human feedback and support. This study is innovative in successfully developing and verifying the effects of a new CBT approach with a multidisciplinary team based on digital technologies rather than standalone technology-based interventions. Trial Registration ClinicalTrials.gov NCT03465306; https://clinicaltrials.gov/ct2/show/NCT03465306

Healthy Eating Behavior Change with Psychological Features and Insulin Resistance: Buffet and Food Diary App Analysis

“…Table 1 shows all participants' baseline characteristics in both the dCBT and control groups; details have been published previously 26 . Changes in eating behavior phenotypes (treatment e cacy) overall results of calorie intake per meal were reported in a previous study 26 . Figure 3 shows the results of food intake changes per meal assessed by the food diary in the app (Appendix A, Table A5 and A6).…”

“…This investigation followed up on ndings initially addressed in a digital cognitive behavioral therapy (dCBT) study 26 . It was found that dCBT successfully induced lifestyle modi cations, thereby supporting a healthy weight.…”

“…The trial was registered with ClinicalTrials.gov NCT03465306 in 18 September 2017, https://register.clinicaltrials.gov/NCT03465306. The detailed design and methods have been published elsewhere 26 . Brie y, the 70 subjects in this study (all female) were randomly assigned to a control (app only) group or a dCBT (app + human CBT) group at a ratio of 1 to 2.…”

“…In addition, the psychological measures were assessed using a brief form of the Body Shape Questionnaire-8C (BSQ-8C), the Korean version of the Beck's Depression Inventory (K-BDI-II), the Trait Anxiety Inventory, the Rosenberg Self-Esteem Scale, the Dutch Eating Behavior Questionnaire (DEBQ), and the Automatic Thoughts Questionnaire (ATQ-30). All these questionnaires were in Korean, and detailed explanations can be found elsewhere 26 .…”

“…Accordingly, the diverse components relevant to each participant's behavior, cognition, emotion, and motivation in the dCBT group were observed and examined during the 8-week active intervention. A detailed description of the intervention procedures is provided by Kim et al 26…”