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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.

Primary Purpose

Obesity, Binge-Eating Disorder, Group Meetings

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Multi-disciplinary obesity management therapy
Sponsored by
Adana City Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, weight loss, Binge-Eating Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Adana City Training and Research Hospital Obesity Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study Group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2019
Last Updated
January 3, 2020
Sponsor
Adana City Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04127136
Brief Title
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.
Official Title
Effects of Multi-Disciplinary Training Therapy On Binge Eating Episodes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
November 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adana City Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Binge-Eating Disorder, Group Meetings, Weight Loss
Keywords
obesity, weight loss, Binge-Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multi-disciplinary obesity management therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the severity of binge-eating disorder
Description
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.
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Adana City Training and Research Hospital Obesity Center
City
Yüreğir
State/Province
Adana
ZIP/Postal Code
01130
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24991159
Citation
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.
Results Reference
background
PubMed Identifier
27532941
Citation
Bulik CM, Kleiman SC, Yilmaz Z. Genetic epidemiology of eating disorders. Curr Opin Psychiatry. 2016 Nov;29(6):383-8. doi: 10.1097/YCO.0000000000000275.
Results Reference
background
PubMed Identifier
28425618
Citation
Dakanalis 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.
Results Reference
background
PubMed Identifier
29378481
Citation
Linardon 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.
Results Reference
background
PubMed Identifier
26341898
Citation
Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.
Results Reference
background

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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.

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