Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity
NCT ID: NCT06495619
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-08-01
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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(1)TAU
treatment-as-usual for weight loss (TAU)
treatment-as-usual
life style modification intervention for weight loss
(2)TAU+GSH
combined TAU and guided self-help for improving eating behaviors (TAU+GSH)
combined TAU and guided self-help
combined TAU and guided self-help for improving eating behaviors
(3)TAU+GSH+BF
combined TAU, GSH, and biofeedback (TAU+GSH+BF)
combined TAU, GSH, and biofeedback
combined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation
Interventions
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treatment-as-usual
life style modification intervention for weight loss
combined TAU and guided self-help
combined TAU and guided self-help for improving eating behaviors
combined TAU, GSH, and biofeedback
combined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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G. d'Annunzio University
OTHER
Responsible Party
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CHIARA CONTI
Associate professor
Central Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Prot. n. 254
Identifier Type: -
Identifier Source: org_study_id
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