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

ConditionsBinge EatingOverweight and Obesity
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorG. d'Annunzio University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • treatment-as-usual

    Behavioral

    life style modification intervention for weight loss

  • combined TAU and guided self-help

    Behavioral

    combined TAU and guided self-help for improving eating behaviors

  • combined TAU, GSH, and biofeedback

    Behavioral

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

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: (1)TAUActive comparator 1 intervention
Group B: (2)TAU+GSHActive comparator 1 intervention
Group C: (3)TAU+GSH+BFActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

objective BE episodes (OBEs)

The primary outcomes will be self-reported reduction of days with objective BE episodes (OBEs)

Time frame
12-week follow-up-1 4-month follow-up-2 (after the end-of-treatment)

Secondary outcomes

1

psychological variables

The secondary outcomes will be impulsivity, emotion dysregulation, interoceptive awareness, distress.

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

physiological correlates of arousal

The secondary outcomes will be skin conductance and heart rate variability.

Time frame
(T0) baseline; (T1)12-week follow-up-1; (T2) 4-month follow-up-2 (after the end-of-treatment)
3

inflammatory biomarkers

The secondary outcomes will be ClpB protein and IgG

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

G. d'Annunzio University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: