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Status unknownNCT05641350BITEUpdated Dec 5, 2023

Barlow's unIfied Protocol for emoTional Eating (BITE): a Pre-post Design

An interventional study of Barlow's Unified Protocol in Emotional Eating, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This study aims to evaluate the efficacy of a group intervention program, based on the Barlow's protocol, in patients with emotional eating with the aim of improving the emotional eating pattern.

The design is quasi-experimental pre-post with a control group (waiting list) and evaluation of the maintenance of the response after 6 months of the end of the program.

Includes outpatients from the Eating Disorders Unit and the Psychiatry Unit of a Hospital. A sample size of 26 participants is considered in the experimental group, and another 26 more in the control group.

02

Conditions studied

  • Emotional Eating
03

In context

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Outpatients from eating behavior disorder outpatient clinics and psychiatric outpatient clinics.
  • Age between 18 and 65 years.
  • Score of more than 2.46 on the "emotional eating" subscale of the DEBQ scale

Exclusion criteria

Exclusion Criteria:

  • Diagnosis of active Eating Disorder, that is, without at least 6 months of symptomatic remission or that exceed the cut-off point on the EAT-26 scale.
  • Patients with severe mental disorder with or without psychotic symptoms (schizophreniform disorders, bipolar spectrum disorders, major depression)
  • Patients with some other medical disorder that presents with impulse dysregulation, such as epilepsy, frontal-type dementia...
  • Patients with an IQ \< 85
  • Patients who do not give consent.
  • Patients who do not understand or speak Spanish or Catalan.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Emotional eating intervention

    Emotional eating intervention

    Behavioral: Barlow's Unified Protocol

  • No intervention
    Waiting list

    Waiting list

Interventions

  • BehavioralBarlow's Unified Protocol

    Adaptation of the cognitive-behavioral Barlow's Unified Protocol for emotional eating pattern.

06

What researchers measure

Primary outcomes

  1. Emotional eating score assessed by the Emotional eating sub-scale of the Dutch Eating Behavior Questionnaire (DEBQ-EE)

    Time frame: 8 weeks

07

Study locations

1 site
  • Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau
    Barcelona, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05641350
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party
Sponsor
First posted
Dec 7, 2022
Start date
Dec 1, 2022
Primary completion
Nov 1, 2023
Completion
Dec 1, 2023 (estimated)
Last update
Dec 5, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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