Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity

NCT06495619 | Not Yet Recruiting

• 1 other identifier: Prot. n. 254
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.treatment-as-usual for weight loss (TAU);
2. 2.combined TAU and guided self-help for improving eating behaviors (TAU+GSH);
3. 3.combined TAU, GSH, and biofeedback (TAU+GSH+BF). The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs).

Conditions

Binge Eating; Overweight and Obesity

Keywords

Binge Eating; Overweight; Obesity; Guided Self-Help; Biofeedback

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (3)

• psychological variables

  (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)

• physiological correlates of arousal

  (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)

• inflammatory biomarkers

  (T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)

Study Arms (3)

(1)TAU

ACTIVE COMPARATOR

treatment-as-usual for weight loss (TAU)

Behavioral: treatment-as-usual

(2)TAU+GSH

ACTIVE COMPARATOR

combined TAU and guided self-help for improving eating behaviors (TAU+GSH)

Behavioral: combined TAU and guided self-help

(3)TAU+GSH+BF

ACTIVE COMPARATOR

combined TAU, GSH, and biofeedback (TAU+GSH+BF)

Behavioral: combined TAU, GSH, and biofeedback

Interventions

treatment-as-usual BEHAVIORAL

life style modification intervention for weight loss

Also known as: TAU

(1)TAU

combined TAU and guided self-help BEHAVIORAL

combined TAU and guided self-help for improving eating behaviors

Also known as: TAU+GSH

(2)TAU+GSH

combined TAU, GSH, and biofeedback BEHAVIORAL

combined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation

Also known as: TAU+GSH+BF

(3)TAU+GSH+BF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• G. d'Annunzio University: lead

Related Publications (6)

• 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.

  PMID: 23171536 BACKGROUND

• 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.

  PMID: 19447358 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.

  PMID: 36369513 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.

  PMID: 34174949 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.

  PMID: 28768334 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.

  PMID: 22477926 BACKGROUND

MeSH Terms

Conditions

Bulimia; Overweight; Obesity

Interventions

Glutathione; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

CHIARA CONTI, PhD

CONTACT

+3908713555338; cconti@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 30, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share