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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (1)TAU | Active Comparator | treatment-as-usual for weight loss (TAU) |
|
| (2)TAU+GSH | Active Comparator | combined TAU and guided self-help for improving eating behaviors (TAU+GSH) |
|
| (3)TAU+GSH+BF | Active Comparator | combined TAU, GSH, and biofeedback (TAU+GSH+BF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment-as-usual | Behavioral | life style modification intervention for weight loss |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective BE episodes (OBEs) | The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs) | 12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| psychological variables | The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress. | (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment) |
| physiological correlates of arousal |
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Inclusion Criteria:(1) age 18-65 years; (2) BMI≥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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CHIARA CONTI, PhD | Contact | +3908713555338 | cconti@unich.it |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23171536 | Background | de Zwaan M, Herpertz S, Zipfel S, Tuschen-Caffier B, Friederich HC, Schmidt F, Gefeller O, Mayr A, Lam T, Schade-Brittinger C, Hilbert A. INTERBED: internet-based guided self-help for overweight and obese patients with full or subsyndromal binge eating disorder. A multicenter randomized controlled trial. Trials. 2012 Nov 21;13:220. doi: 10.1186/1745-6215-13-220. | |
| 19447358 |
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The data sets generated during and/or analysed during the current study are available from the PI on reasonable request.
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| ID | Term |
|---|---|
| D002032 | Bulimia |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005978 | Glutathione |
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D026441 | Mind-Body Therapies |
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| combined TAU and guided self-help | Behavioral | combined TAU and guided self-help for improving eating behaviors |
|
|
| combined TAU, GSH, and biofeedback | Behavioral | combined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation |
|
|
The secondary outcomes will be skin conductance and heart rate variability. |
| (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 | (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment) |
| DiMarco ID, Klein DA, Clark VL, Wilson GT. The use of motivational interviewing techniques to enhance the efficacy of guided self-help behavioral weight loss treatment. Eat Behav. 2009 Apr;10(2):134-6. doi: 10.1016/j.eatbeh.2009.02.001. Epub 2009 Feb 15. |
| 36369513 | Background | Mueller J, Richards R, Jones RA, Whittle F, Woolston J, Stubbings M, Sharp SJ, Griffin SJ, Bostock J, Hughes CA, Hill AJ, Boothby CE, Ahern AL. Supporting Weight Management during COVID-19 (SWiM-C): twelve-month follow-up of a randomised controlled trial of a web-based, ACT-based, guided self-help intervention. Int J Obes (Lond). 2023 Jan;47(1):51-59. doi: 10.1038/s41366-022-01232-x. Epub 2022 Nov 11. |
| 34174949 | Background | Varela C, Oda-Montecinos C, Andres A, Saldana C. Effectiveness of web-based feedback interventions for people with overweight and obesity: systematic review and network meta-analysis of randomized controlled trials. J Eat Disord. 2021 Jun 26;9(1):75. doi: 10.1186/s40337-021-00432-6. |
| 28768334 | Background | de Zwaan M, Herpertz S, Zipfel S, Svaldi J, Friederich HC, Schmidt F, Mayr A, Lam T, Schade-Brittinger C, Hilbert A. Effect of Internet-Based Guided Self-help vs Individual Face-to-Face Treatment on Full or Subsyndromal Binge Eating Disorder in Overweight or Obese Patients: The INTERBED Randomized Clinical Trial. JAMA Psychiatry. 2017 Oct 1;74(10):987-995. doi: 10.1001/jamapsychiatry.2017.2150. |
| 22477926 | Background | Frank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91. |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D000529 |
| Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |