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

July 3, 2024 updated by: CHIARA CONTI, G. d'Annunzio University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: CHIARA CONTI, PhD
  • Phone Number: +3908713555338
  • Email: cconti@unich.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (1)TAU
treatment-as-usual for weight loss (TAU)
Behavioral: treatment-as-usual
life style modification intervention for weight loss
Other Names:
  • TAU
Active Comparator: (2)TAU+GSH
combined TAU and guided self-help for improving eating behaviors (TAU+GSH)
Behavioral: combined TAU and guided self-help
combined TAU and guided self-help for improving eating behaviors
Other Names:
  • TAU+GSH
Active Comparator: (3)TAU+GSH+BF
combined TAU, GSH, and biofeedback (TAU+GSH+BF)
Behavioral: combined TAU, GSH, and biofeedback
combined TAU, GSH, and biofeedback for improving eating behaviors and interoceptive awareness and arousal regulation
Other Names:
  • TAU+GSH+BF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
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.
(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
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
(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

G. d'Annunzio University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prot. n. 254

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data sets generated during and/or analysed during the current study are available from the PI on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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