Feasibility Trial of Getting Better Bite by Bite for Eating Disorders
NCT ID: NCT05724394
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
84 participants
INTERVENTIONAL
2023-04-28
2024-12-30
Brief Summary
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Detailed Description
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Quantitative phase of this research aims to determine if the culturally adapted GBBB (Ca-GBBB) programme is feasible and acceptable for individuals with Eating disorders- BN and BED compared to treatment as usual.
The qualitative part of the study will include focus groups and in-depth digitally recorded one-to-one interviews with participants by trained qualitative researchers at two time points both before and after the intervention. These focus groups and in-depth interviews will continue till the data saturation is achieved. Moreover, in-depth digitally-recorded interviews with stakeholders (nutritionists, dietitian, educationist, therapists, health professionals, etc) will also be conducted by trained researchers.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ca-GBBB arm
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.
Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention
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.
Treatment As Usual
Treatment as Usual (TAU) group will receive routine care and their follow up will be done at 4-month post-randomization.
No interventions assigned to this group
Interventions
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Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention
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.
Eligibility Criteria
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Inclusion Criteria
2. Screen positive on the Binge Eating Screening Questionnaire and/or Bulimic Investigatory test, Edinburgh
3. Residents of the study catchment area
4. Able to provide informed consent
Exclusion Criteria
2. Presence of any severe mental or physical illness that would prevent individual from participating in the intervention and or assessments.
3. Temporary resident unlikely to be available for follow-up
18 Years
ALL
No
Sponsors
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Pakistan Institute of Living and Learning
OTHER
Responsible Party
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Locations
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Lahore site
Lahore, Punjab Province, Pakistan
Countries
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References
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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.
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.
Other Identifiers
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PILL-GBBB-ED
Identifier Type: -
Identifier Source: org_study_id
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