Feasibility Trial of Getting Better Bite by Bite for Eating Disorders

NCT05724394 | Active Not Recruiting DMC

• 1 other identifier: PILL-GBBB-ED
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This is a mixed method feasibility randomized controlled trial to explore the feasibility and acceptability of therapist delivered, culturally adapted, manualized Ca-GBBB intervention for Eating Disorders (EDs) - Bulimia Nervosa (BN) and Bing Eating Disorder (BED) in Pakistan.

Conditions

Eating Disorders; Bulimia Nervosa; Binge-Eating Disorder

Keywords

Getting better bite by bite (GBBB); Culturally Adapted Intervention; Low resource settings; Pakistan; Eating Disorders; Feasibility Study

Outcome Measures

Primary Outcomes (4)

• Recruitment and attrition Logs

  The parameters feasibility of undertaking the trial of intervention will include the recruitment rate (the number of patients referred/approached, proportion of those who consented out of all the eligible patients with BED and/or BN disorder referred from and approached at the recruitment sites) (The success criterion of feasibility will be to recruit \> 50% of eligible participants) and the attrition rate (the number of patients withdrawn out of those who consented to participate).

  One year's time

• Intervention Log

  Feasibility of the intervention delivery: Duration of each session and completed feedback forms. This will be assessed by keeping record of whether the Ca-GBBB is delivered, received and enacted as intended.

  During 4-month intervention period.

• Attendance logs

  Therapy logs will include each participant's attendance in a session. This will give information about acceptability of intervention. mean attendance rate of \>70% i.e. at least 11 sessions, will indicate that the intervention is acceptable for the participants

  From baseline to 4-month follow up

• Client Satisfaction Questionnaire

  Tolerability of the intervention is defined as the ability to endure the intervention. Items on Client Satisfaction Questionnaire are scored on a four-point Likert scale from 1 (low satisfaction) to 4 (high satisfaction), with different descriptors for each response point. Totals range from 8 to 32; with higher scores indicating greater satisfaction.

  From baseline to 4-month follow up

Secondary Outcomes (9)

• The Bulimic Investigatory Test, Edinburgh

  Change in score from baseline to 4-month follow-up.

• Binge-Eating Disorder Screener

  Change in score from baseline to 4-month follow-up

• The Sick, Control, One, Fat, Food

  Change in score from baseline to 4-month follow-up

• Eating Disorder Examination Questionnaire

  Change in score from baseline to 4-month follow-up

• Kessler Psychological Distress Scale

  Change in score from baseline to 4-month follow-up

Study Arms (2)

Ca-GBBB arm

EXPERIMENTAL

The Ca-GBBB strongly focuses on enhancing participant's motivation and belief in their ability to change. The intervention will be comprised of 16-week training program delivered over four months. Sessions will be delivered weekly and each session will last about 45-50 minutes. All sessions will be delivered by master level psychologist. The manual will be translated to Urdu giving special consideration to cultural adaptation of phrases and concepts to reflect Pakistani culture. Additionally, culturally appropriate case scenarios will be incorporated and a consensual view to addressing cultural factors such as gender role, financial difficulties will be taken into consideration. The time and venue of session will be decided prior according to participant convenience.

Other: Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention

Treatment As Usual

NO INTERVENTION

Treatment as Usual (TAU) group will receive routine care and their follow up will be done at 4-month post-randomization.

Interventions

Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention OTHER

The Ca-GBBB strongly focuses on enhancing participant's motivation and belief in their ability to change. The intervention will be comprised of 16-week training program delivered over four months.

Ca-GBBB arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age18 years
• Screen positive on the Binge Eating Screening Questionnaire and/or Bulimic Investigatory test, Edinburgh
• Residents of the study catchment area
• Able to provide informed consent

You may not qualify if:

• Aged under 18
• Presence of any severe mental or physical illness that would prevent individual from participating in the intervention and or assessments.
• Temporary resident unlikely to be available for follow-up

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Lahore site

Lahore, Punjab Province, 203393, Pakistan

Location

Related Publications (2)

• Atwood ME, Friedman A. A systematic review of enhanced cognitive behavioral therapy (CBT-E) for eating disorders. Int J Eat Disord. 2020 Mar;53(3):311-330. doi: 10.1002/eat.23206. Epub 2019 Dec 16.

  PMID: 31840285 RESULT

• Khaliq A, Muazzam A, Rafique R, Kiran T, Ahmed A, Suleheria I, Chaudhry N, Husain N. A feasibility randomized controlled trial of culturally adapted Getting Better Bite-by-Bite (Ca-GBBB) intervention for individuals with eating disorders in Pakistan. J Eat Disord. 2024 Jul 17;12(1):100. doi: 10.1186/s40337-024-01038-4.

  PMID: 39020405 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia Nervosa; Binge-Eating Disorder

Interventions

Methods

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility Randomized Controlled Trial with participants randomized into two trial arms

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: February 13, 2023
• Study Start: April 28, 2023
• Primary Completion: March 31, 2024
• Study Completion: December 30, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PA (1)