Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity (BE-side)

G. d'Annunzio University

Status: Not yet enrolling

Conditions: Overweight and Obesity; Binge Eating

Treatments: Behavioral: combined TAU and guided self-help; Behavioral: combined TAU, GSH, and biofeedback; Behavioral: treatment-as-usual

Study type: Interventional

Funder types: Other

Identifiers

NCT06495619

Prot. n. 254

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria: (1) current treatment for BE with a registered psychologist; (2) severe psychiatric disorders; (4) cognitive impairment; (5) pregnancy; (6) severe medical comorbidity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

(1)TAU

Active Comparator group

Description:

treatment-as-usual for weight loss (TAU)

Treatment:

Behavioral: treatment-as-usual

(2)TAU+GSH

Active Comparator group

Description:

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

Treatment:

Behavioral: combined TAU and guided self-help

(3)TAU+GSH+BF

Active Comparator group

Description:

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

Treatment:

Behavioral: combined TAU, GSH, and biofeedback