The main goal of the clinical trial is to compare the short- and long-term outcomes of three 12-week interventions among outpatients with overweight/obesity and binge eating (BE): 1. treatment-as-usual for weight loss (TAU); 2. combined TAU and guided self-help for improving eating behaviors (TAU+GSH); 3. combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs). The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress, physiological correlates of arousal (skin conductance and heart rate variability), and inflammatory biomarkers. The TAU+GSH arm is expected to be comparable to the TAU+GSH+BF arm in reducing the number of days with OBEs but is expected to be significantly less effective in improving secondary outcomes (impulsivity, emotional dysregulation, interoceptive awareness, distress, physiological inflammatory markers). The TAU arm is expected to show significant inferiority regarding the primary and secondary outcomes and cost-effectiveness compared to the TAU+GSH and TAU+GSH+BF conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
life style modification intervention for weight loss
combined TAU and guided self-help for improving eating behaviors
combined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation
objective BE episodes (OBEs)
The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs)
Time frame: 12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)
psychological variables
The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress.
Time frame: (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
physiological correlates of arousal
The secondary outcomes will be skin conductance and heart rate variability.
Time frame: (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
inflammatory biomarkers
The secondary outcomes will be ClpB protein and IgG
Time frame: (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
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