An interventional study of treatment-as-usual and combined TAU and guided self-help in Binge Eating and Overweight and Obesity, sponsored by G. d'Annunzio University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment
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):
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.
173 studies on the registry are indexed under Bulimia; 33 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 143 interventional studies indexed under Bulimia.
Browse Bulimia studies →G. d'Annunzio University is the lead sponsor of 67 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:(1) age 18-65 years; (2) ≥25 kg/m2; (3) ability to read and write in Italian; (4) Binge Eating Disorder (BED) or subthreshold BED status.
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Exclusion Criteria: (1) current treatment for BE with a registered psychologist; (2) severe psychiatric disorders; (4) cognitive impairment; (5) pregnancy; (6) severe medical comorbidity.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
treatment-as-usual for weight loss (TAU)
Behavioral: treatment-as-usual
combined TAU and guided self-help for improving eating behaviors (TAU+GSH)
Behavioral: combined TAU and guided self-help
combined TAU, GSH, and biofeedback (TAU+GSH+BF)
Behavioral: combined TAU, GSH, and biofeedback
life style modification intervention for weight loss
Also known as: TAU
combined TAU and guided self-help for improving eating behaviors
Also known as: TAU+GSH
combined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation
Also known as: TAU+GSH+BF
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)
No study locations are listed for this record.
Plan to share: No — The data sets generated during and/or analysed during the current study are available from the PI on reasonable request.
Start is estimated for Aug 2024; primary completion for Dec 2024, 4 months later.
Of 68 non-industry interventional studies with no phase under Bulimia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's planned 4 months is below that.
Counting every sponsor, half of 70 studies reached it within 26 months; a quarter within 10 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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G. d'Annunzio University