Eating DisordersCaGBBBNCT05724394
Feasibility Trial of Getting Better Bite by Bite for Eating Disorders
A study testing Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention in people with Eating Disorders and Bulimia Nervosa, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder
- What is being tested?
- Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Apr 2023to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Randomized Controlled Trial of Culturally Adapted Getting Better Bite-by-Bite (Ca-GBBB)Intervention for Individuals With Eating Disorders in Pakistan
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.
Read the detailed description
Evidence on psychological management of eating disorders in low and middle income countries ( LMICs) is limited, and non-existent in Pakistan. A Cognitive Behaviour Therapy (CBT) based guided self-help manual "Getting Better Bite by Bite: A Survival Kit for Sufferers of Bulimia Nervosa and Binge Eating Disorders" (GBBB), has found to be feasible and acceptable for patients with BN.
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
- Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder
- Being tested
- Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention
- Keywords
- Getting better bite by bite (GBBB), Culturally Adapted Intervention, Low resource settings, Pakistan, Eating Disorders, Feasibility Study
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: From baseline to 4-month follow up
Secondary outcomes (9)
The Bulimic Investigatory Test, Edinburgh
The BITE is a 33-item self-rating scale (Henderson and Freeman 1987). It consists of two subscales: The Symptom Scale (30 items), which measures the degree of symptoms and the Severity Scale (3 items), which provides an index of the severity as defined by the frequency of binge-eating and purging behavior. The total score for all the questions gives a "symptom score" - a score of 15 or above indicate that the individuals has a lot of thoughts and attitudes consistent with eating disorders. The toral score of question 6, 7 and 27 will give a severity index - a score of 5 or above signifies an eating disorder
Measured: Change in score from baseline to 4-month follow-up.
Binge-Eating Disorder Screener
The 7-item Binge-Eating Disorder Screener (BEDS-7), a brief screener for BED, can assist physicians in identifying patients who may have BED. Those with a score of 2-3 are considered mildly at risk of BED, a score of 4-5 is determined to be moderately at risk for BED, and a score of 6 indicates severely at risk for BED
Measured: Change in score from baseline to 4-month follow-up
The Sick, Control, One, Fat, Food
5 item questionnaire that covers the main three domains which are anorexia nervosa, bulimia nervosa, or other eating disorders. Each yes answer means 1 point and if the interviewee gets 2 points it reveals that he/she has anorexia nervosa or bulimia.
Measured: Change in score from baseline to 4-month follow-up
Eating Disorder Examination Questionnaire
a 28-item self-reported questionnaire adapted from the semi-structured interview Eating Disorder Examination (EDE) and designed to assess the range and severity of features associated with a diagnosis of eating disorder using 4 subscales (Restraint, Eating Concern, Shape Concern and Weight Concern) and a global score. Higher scores on the global scale and subscales denote more problematic eating behaviours and attitudes. A cut-off of 4 on the global score is generally used as clinically significant
Measured: Change in score from baseline to 4-month follow-up
Kessler Psychological Distress Scale
It is used to measure psychological distress. It's a 10 item scale measuring emotional states with a 5 level response scale. Scores will range from 10 to 50. Low scores indicate low levels of psychological distress and high scores indicate high levels of psychological distress. score 10 - 19 Likely to be well, 20 - 24 Likely to have a mild disorder, 25 - 29 Likely to have a moderate disorder and 30 - 50 Likely to have a severe disorder
Measured: Change in score from baseline to 4-month follow-up
Beck Scale for Suicidal Ideation
The BSS is a 21-item measure that will be used to assess the frequency and intensity of suicidal thoughts. Each item is scored based on an ordinal scale from 0 to 2 and the total score is 0 to 38. Individuals answer to the first 5 items which is excerpted. If individual's answer to the fifth item is positive (scores 1 and 2), he/she answers the rest of the items and otherwise the questionnaire is completed. No cut- point is used to categorize the scores
Measured: Change in score from baseline to 4-month follow-up
Beck Depression Inventory
The BDI is a 29 item questionnaire that will be used to measure severity of depression. Score 1-10 are considered normal, 11-16 Mild mood disturbance, 17-20 Borderline clinical depression, 21-30 Moderate depression, 31-40 Severe depression over 40 Extreme depression
Measured: Change in score from baseline to 4-month follow-up
Oslo- 3 Social Support Scale
O3SSS will be used to assess the relationship with friends, family and neighbors. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support. The OSSS-3 sum score can be operationalized into three broad categories of social support: a) 3-8 poor social support, b) 9-11 moderate social support, c) 12-14 strong social support
Measured: Change in score from baseline to 4-month follow-up
Client Satisfaction Questionnaire
Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire (CSQ). Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction
Measured: Change in score from baseline to 4-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start28 Apr 2023
- Primary completion31 Mar 2024
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility Randomized Controlled Trial with participants randomized into two trial arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724394
- Sponsor's protocol ID
- PILL-GBBB-ED
- Acronym
- CaGBBB
- Status last verified
- May 2024
- First submitted
- 9 Dec 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised data will be shared on request
Publications
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.
PubMed 31840285Khaliq 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.
PubMed 39020405
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomized Controlled Trial of Culturally Adapted Getting Better Bite-by-Bite (Ca-GBBB)Intervention for Individuals With Eating Disorders in Pakistan
- ClinicalTrials.gov ID
- NCT05724394
- Acronym / sponsor ID
- CaGBBB / PILL-GBBB-ED
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Evidence on psychological management of eating disorders in low and middle income countries ( LMICs) is limited, and non-existent in Pakistan. A Cognitive Behaviour Therapy (CBT) based guided self-help manual "Getting Better Bite by Bite: A Survival Kit for Sufferers of Bulimia Nervosa and Binge Eating Disorders" (GBBB), has found to be feasible and acceptable for patients with BN.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Feasibility Randomized Controlled Trial with participants randomized into two trial arms
| Arm | Type | Receives |
|---|---|---|
| Ca-GBBB arm | Experimental | Other: Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) interventionThe 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. | Other | Ca-GBBB arm |
Primary outcome
Recruitment and attrition Logs
Time frame: One year's time
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).
Intervention Log
Time frame: During 4-month intervention period.
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.
Attendance logs
Time frame: From baseline to 4-month follow up
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
Client Satisfaction Questionnaire
Time frame: From baseline to 4-month follow up
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.
9 secondary outcomes
The Bulimic Investigatory Test, Edinburgh
Time frame: Change in score from baseline to 4-month follow-up.
Binge-Eating Disorder Screener
Time frame: Change in score from baseline to 4-month follow-up
The Sick, Control, One, Fat, Food
Time frame: Change in score from baseline to 4-month follow-up
Eating Disorder Examination Questionnaire
Time frame: Change in score from baseline to 4-month follow-up
Kessler Psychological Distress Scale
Time frame: Change in score from baseline to 4-month follow-up
Beck Scale for Suicidal Ideation
Time frame: Change in score from baseline to 4-month follow-up
Beck Depression Inventory
Time frame: Change in score from baseline to 4-month follow-up
Oslo- 3 Social Support Scale
Time frame: Change in score from baseline to 4-month follow-up
Client Satisfaction Questionnaire
Time frame: Change in score from baseline to 4-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Results publication: PubMed 31840285Atwood 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.
- Derived from this study: PubMed 39020405Khaliq 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.
- Individual participant dataSharing planned: Yes. The anonymised data will be shared on request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Adapted Getting Better Bite By Bite (Ca-GBBB) intervention in people with Eating Disorders and Bulimia Nervosa, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and attrition Logs (time frame: One year's time). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05724394, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.