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

Effectiveness of Integrative Intervention Strategies for Binge Eating in Patients With Overweight or Obesity: A Multidisciplinary Approach

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06495619

Acronym

BE-side

Enrollment

100

Registered

2024-07-11

Start date

2024-08-01

Completion date

2025-06-30

Last updated

2024-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Binge Eating, Overweight and Obesity

Keywords

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

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. 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.

Interventions

BEHAVIORALtreatment-as-usual

life style modification intervention for weight loss

BEHAVIORALcombined TAU and guided self-help

combined TAU and guided self-help for improving eating behaviors

BEHAVIORALcombined TAU, GSH, and biofeedback

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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. \-

Design outcomes

Primary

Measure	Time frame	Description
objective BE episodes (OBEs)	12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)	The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs)

Secondary

Measure	Time frame	Description
psychological variables	(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)	The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress.
physiological correlates of arousal	(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)	The secondary outcomes will be skin conductance and heart rate variability.
inflammatory biomarkers	(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)	The secondary outcomes will be ClpB protein and IgG

Contacts

Primary ContactCHIARA CONTI, PhD

cconti@unich.it+3908713555338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026