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NCT Number: NCT06495619

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

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.

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Key information

Conditions

Binge Eating Body Weight Bulimia Hyperphagia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Treatment-as-usual

Behavioral

life style modification intervention for weight loss

Other names: TAU

combined TAU and guided self-help

Behavioral

combined TAU and guided self-help for improving eating behaviors

Other names: TAU+GSH

combined TAU, GSH, and biofeedback

Behavioral

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

Other names: TAU+GSH+BF

Primary outcomes

  1. objective BE episodes (OBEs)

    Time frame: 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 outcomes

  1. psychological variables

    Time frame: (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.

  2. physiological correlates of arousal

    Time frame: (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.

  3. inflammatory biomarkers

    Time frame: (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

Study contacts

Contact information is provided by the study sponsor or research team.

CHIARA CONTI, PhD

CONTACT

[email protected]

+3908713555338

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Acronym: BE-side

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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