ObesityNCT04127136
Analysis of the Effects of the Adana City Training and Research Hospital Obesity Center Training Program on Adult Obese Patients With Binge Eating Disorder. A Prospective, Quasi-experimental Study With Interrupted Time-series Design.
A study testing Multi-disciplinary obesity management therapy in people with Obesity and Binge-Eating Disorder, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Outcomes of treatments for binge eating spectrum eating disorders are yet to yield desirable results, reporting up to 60-70% of patients remaining symptomatic at post-treatment. Adana City Training and Research Hospital Obesity Center is designed to provide multi-disciplinary health care services and training for… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Binge-Eating Disorder, Group Meetings
- What is being tested?
- Multi-disciplinary obesity management therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2019to 29 Nov 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having registered to the center for training
- passed the first three steps
- body mass index (BMI) equal to or over 30
- having binge eating disorder
Who cannot join
- having an untreated medical condition
- having a mismanaged medical condition
- failing to attend more than 4 meetings
- failing to complete a binge eating disorder evaluation form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Training and Research Hospital Obesity Center
Yüreğir, Adana, 01130
About this study
Official title: Effects of Multi-Disciplinary Training Therapy On Binge Eating Episodes
Outcomes of treatments for binge eating spectrum eating disorders are yet to yield desirable results, reporting up to 60-70% of patients remaining symptomatic at post-treatment.
Adana City Training and Research Hospital Obesity Center is designed to provide multi-disciplinary health care services and training for groups of obese patients seeking professional help. The center includes a physician, dietitian, physiotherapist, psychologist, public relations officer, and a nurse acting as a life coach. Program is planned to carry initial assessment, health screening, necessary medical attention related to obesity, cognitive change, behavioral change, and sustainability activities. The initial assessment part consisted of one on one interviews of the patient with the physician, psychologist, dietitian, physiotherapist, and the nurse. Then, the patient is consulted with an endocrinologist, cardiologist, psychiatrist, and physical therapy and rehabilitation specialist to elucidate the significant factors that resulted in excessive weight gain and barriers in losing. Patients with severe or mismanaged medical conditions, including chronic diseases, neurological diseases, significant affective and psychotic disorders, and substance abuse or addiction disorders were directed to relevant clinics before registration. The patients who completed the screening are arranged into groups and weekly group meetings are planned. In two group meetings, basic medical knowledge and frequently asked questions are discussed. The center staff and the patients get acquinted. In the following twenty weeks, trainings by the physician, dietitian, psychologist and physiotherapist are conducted about medical information about obesity, using the technology to aid weight loss, what, when, how and why to eat, nutrition groups, ration management, water consumption, self-awareness, stress management, obesity and the association between the psychological processes, warming up and mobilization, correct stance and posture, and adequate physical activity. In addition to group meetings, in monthly individual meetings, the progress of the patients are evaluated.
Read more
During the course of the program the patients with BED reported improvements in BED episodes and increased weight loss rate which give the idea to conduct a study. The primary goal of the study was to analyze the change in the severity of binge eating disorder in patients registered to the program. We expected to show a decrease in the frequency of the BED episodes in all the patients. The secondary goal includes the analysis of the context of the training program to compare the effectiveness of the topics and the methods.
The study was a single-arm, prospective, quasi-experimental study with interrupted time-series design. There were no sampling methods; all patients registered to the center program with binge eating disorder and completed the acquaintance step were asked to be included. Inclusion criteria were having registered to the center for training, passed the first three steps, age between 18 to 65 years, a body mass index (BMI) equal to or over 30, and having binge eating disorder. Patients who failed to attend more than four pieces of training and complete a binge eating evaluation were excluded from the study. The training materials were developed by the trainers and edited by the author for the final version before training.
The cases were analyzed for the change in the severity of binge eating disorder in the program. The data collection was performed via socio-demographic information form, binge eating disorder evaluation (BEDE) form, and progress record forms. BEDE was a structured form exclusively using DSM-5 BED diagnosis and the severity criteria1. Progress record form included weekly session content that was administered by a physician, dietitian, psychologist, and the physiotherapist and the monthly individual meetings data. BEDE and progress record forms were applied before the trainings that focuses on cognitive change and repeated every four weeks for 20 weeks. The patients were planned to receive 80 hours of training by the physician, dietitian, psychologist, and the physiotherapist.
- Conditions
- Obesity, Binge-Eating Disorder, Group Meetings, Weight Loss
- Being tested
- Multi-disciplinary obesity management therapy
- Keywords
- obesity, weight loss, Binge-Eating Disorder
- Medical subject headings
- Obesity, Binge-Eating Disorder, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-disciplinary obesity management therapyBehavioural
In twenty weeks, trainings by the physician, dietitian, psychologist and physiotherapist are conducted about medical information about obesity, using the technology to aid weight loss, what, when, how and why to eat, nutrition groups, ration management, water consumption, self-awareness, stress management, obesity and the association between the psychological processes, warming up and mobilization, correct stance and posture, and adequate physical activity. In addition to group meetings, in monthly individual meetings, the progress of the patients are evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | The cases were analyzed for the change in the severity of binge eating disorder in the program. The data collection was performed via socio-demographic information form, binge eating disorder evaluation (BEDE) form, and progress record forms. BEDE was a structured form exclusively using DSM-5 BED diagnosis and the severity criteria. Progress record form included weekly session content that was administered by a physician, dietitian, psychologist, and the physiotherapist and the monthly individual meetings data. BEDE and progress record forms were applied before the trainings that focuses on cognitive change and repeated every four weeks for 20 weeks. The patients were planned to receive 80 hours of training by the physician, dietitian, psychologist, and the physiotherapist. Receives: Behavioral: Multi-disciplinary obesity management therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the severity of binge-eating disorder
The Binge eating disorder form, constructed exclusively using DSM-5 BED diagnosis and the severity criteria, was consisted of 12 questions, addressing major criteria including the characterization of recurrent episodes of binge eating and the sense of lack of control over eating during the episode, the feelings at the time and after eating, the presence of distress and finally the frequency. Based on the frequency of episodes, four severity groups were set according to the weekly episodes: mild, moderate, severe, and extreme, respectively. The first ten questions were in closed forms and designed to detect the presence or the characterization of the episodes. Answers with "yes" reflect the presence of the symptoms or the episodes and mean a worse outcome. The last two focus on the frequency of the symptoms. Higher scores mean a worse outcome. We expected the subjects to show a change in the severity of binge eating episodes.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start20 Jun 2019
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adana City Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Cenk Belibağlı, Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127136
- Sponsor's protocol ID
- 483
- Status last verified
- Jan 2020
- First submitted
- 14 Oct 2019
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qian J, Hu Q, Wan Y, Li T, Wu M, Ren Z, Yu D. Prevalence of eating disorders in the general population: a systematic review. Shanghai Arch Psychiatry. 2013 Aug;25(4):212-23. doi: 10.3969/j.issn.1002-0829.2013.04.003.
PubMed 24991159Bulik CM, Kleiman SC, Yilmaz Z. Genetic epidemiology of eating disorders. Curr Opin Psychiatry. 2016 Nov;29(6):383-8. doi: 10.1097/YCO.0000000000000275.
PubMed 27532941Dakanalis A, Riva G, Serino S, Colmegna F, Clerici M. Classifying Adults with Binge Eating Disorder Based on Severity Levels. Eur Eat Disord Rev. 2017 Jul;25(4):268-274. doi: 10.1002/erv.2518. Epub 2017 Apr 20.
PubMed 28425618Linardon J. Meta-analysis of the effects of cognitive-behavioral therapy on the core eating disorder maintaining mechanisms: implications for mechanisms of therapeutic change. Cogn Behav Ther. 2018 Mar;47(2):107-125. doi: 10.1080/16506073.2018.1427785. Epub 2018 Jan 30.
PubMed 29378481Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.
PubMed 26341898
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multi-Disciplinary Training Therapy On Binge Eating Episodes
- ClinicalTrials.gov ID
- NCT04127136
- Acronym / sponsor ID
- 483
- Conditions
- Obesity, Binge-Eating Disorder, Group Meetings, Weight Loss
- Keywords
- obesity, weight loss, Binge-Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Adana City Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 15 Oct 2019 (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.
Outcomes of treatments for binge eating spectrum eating disorders are yet to yield desirable results, reporting up to 60-70% of patients remaining symptomatic at post-treatment.
Adana City Training and Research Hospital Obesity Center is designed to provide multi-disciplinary health care services and training for groups of obese patients seeking professional help. The center includes a physician, dietitian, physiotherapist, psychologist, public relations officer, and a nurse acting as a life coach. Program is planned to carry initial assessment, health screening, necessary medical attention related to obesity, cognitive change, behavioral change, and sustainability activities. The initial assessment part consisted of one on one interviews of the patient with the physician, psychologist, dietitian, physiotherapist, and the nurse. Then, the patient is consulted with an endocrinologist, cardiologist, psychiatrist, and physical therapy and rehabilitation specialist to elucidate the significant factors that resulted in excessive weight gain and barriers in losing. Patients with severe or mismanaged medical conditions, including chronic diseases, neurological diseases, significant affective and psychotic disorders, and substance abuse or addiction disorders were directed to relevant clinics before registration. The patients who completed the screening are arranged into groups and weekly group meetings are planned. In two group meetings, basic medical knowledge and frequently asked questions are discussed. The center staff and the patients get acquinted. In the following twenty weeks, trainings by the physician, dietitian, psychologist and physiotherapist are conducted about medical information about obesity, using the technology to aid weight loss, what, when, how and why to eat, nutrition groups, ration management, water consumption, self-awareness, stress management, obesity and the association between the psychological processes, warming up and mobilization, correct stance and posture, and adequate physical activity. In addition to group meetings, in monthly individual meetings, the progress of the patients are evaluated.
During the course of the program the patients with BED reported improvements in BED episodes and increased weight loss rate which give the idea to conduct a study. The primary goal of the study was to analyze the change in the severity of binge eating disorder in patients registered to the program. We expected to show a decrease in the frequency of the BED episodes in all the patients. The secondary goal includes the analysis of the context of the training program to compare the effectiveness of the topics and the methods.
The study was a single-arm, prospective, quasi-experimental study with interrupted time-series design. There were no sampling methods; all patients registered to the center program with binge eating disorder and completed the acquaintance step were asked to be included. Inclusion criteria were having registered to the center for training, passed the first three steps, age between 18 to 65 years, a body mass index (BMI) equal to or over 30, and having binge eating disorder. Patients who failed to attend more than four pieces of training and complete a binge eating evaluation were excluded from the study. The training materials were developed by the trainers and edited by the author for the final version before training.
The cases were analyzed for the change in the severity of binge eating disorder in the program. The data collection was performed via socio-demographic information form, binge eating disorder evaluation (BEDE) form, and progress record forms. BEDE was a structured form exclusively using DSM-5 BED diagnosis and the severity criteria1. Progress record form included weekly session content that was administered by a physician, dietitian, psychologist, and the physiotherapist and the monthly individual meetings data. BEDE and progress record forms were applied before the trainings that focuses on cognitive change and repeated every four weeks for 20 weeks. The patients were planned to receive 80 hours of training by the physician, dietitian, psychologist, and the physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: Multi-disciplinary obesity management therapyThe cases were analyzed for the change in the severity of binge eating disorder in the program. The data collection was performed via socio-demographic information form, binge eating disorder evaluation (BEDE) form, and progress record forms. BEDE was a structured form exclusively using DSM-5 BED diagnosis and the severity criteria. Progress record form included weekly session content that was administered by a physician, dietitian, psychologist, and the physiotherapist and the monthly individual meetings data. BEDE and progress record forms were applied before the trainings that focuses on cognitive change and repeated every four weeks for 20 weeks. The patients were planned to receive 80 hours of training by the physician, dietitian, psychologist, and the physiotherapist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having registered to the center for training
- passed the first three steps
- body mass index (BMI) equal to or over 30
- having binge eating disorder
Key exclusion criteria (4 listed)
- having an untreated medical condition
- having a mismanaged medical condition
- failing to attend more than 4 meetings
- failing to complete a binge eating disorder evaluation form
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 |
|---|---|---|
| Multi-disciplinary obesity management therapyIn twenty weeks, trainings by the physician, dietitian, psychologist and physiotherapist are conducted about medical information about obesity, using the technology to aid weight loss, what, when, how and why to eat, nutrition groups, ration management, water consumption, self-awareness, stress management, obesity and the association between the psychological processes, warming up and mobilization, correct stance and posture, and adequate physical activity. In addition to group meetings, in monthly individual meetings, the progress of the patients are evaluated. | Behavioural | Study Group |
Primary outcome
Change in the severity of binge-eating disorder
Time frame: 20 weeks
The Binge eating disorder form, constructed exclusively using DSM-5 BED diagnosis and the severity criteria, was consisted of 12 questions, addressing major criteria including the characterization of recurrent episodes of binge eating and the sense of lack of control over eating during the episode, the feelings at the time and after eating, the presence of distress and finally the frequency. Based on the frequency of episodes, four severity groups were set according to the weekly episodes: mild, moderate, severe, and extreme, respectively. The first ten questions were in closed forms and designed to detect the presence or the characterization of the episodes. Answers with "yes" reflect the presence of the symptoms or the episodes and mean a worse outcome. The last two focus on the frequency of the symptoms. Higher scores mean a worse outcome. We expected the subjects to show a change in the severity of binge eating episodes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Background: PubMed 24991159Qian J, Hu Q, Wan Y, Li T, Wu M, Ren Z, Yu D. Prevalence of eating disorders in the general population: a systematic review. Shanghai Arch Psychiatry. 2013 Aug;25(4):212-23. doi: 10.3969/j.issn.1002-0829.2013.04.003.
- Background: PubMed 27532941Bulik CM, Kleiman SC, Yilmaz Z. Genetic epidemiology of eating disorders. Curr Opin Psychiatry. 2016 Nov;29(6):383-8. doi: 10.1097/YCO.0000000000000275.
- Background: PubMed 28425618Dakanalis A, Riva G, Serino S, Colmegna F, Clerici M. Classifying Adults with Binge Eating Disorder Based on Severity Levels. Eur Eat Disord Rev. 2017 Jul;25(4):268-274. doi: 10.1002/erv.2518. Epub 2017 Apr 20.
- Background: PubMed 29378481Linardon J. Meta-analysis of the effects of cognitive-behavioral therapy on the core eating disorder maintaining mechanisms: implications for mechanisms of therapeutic change. Cogn Behav Ther. 2018 Mar;47(2):107-125. doi: 10.1080/16506073.2018.1427785. Epub 2018 Jan 30.
- Background: PubMed 26341898Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.
- Individual participant dataSharing planned: No
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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 Multi-disciplinary obesity management therapy in people with Obesity and Binge-Eating Disorder, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 6 Jan 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the severity of binge-eating disorder (time frame: 20 weeks). 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 NCT04127136, which also lists 5 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 6 Jan 2020.