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.

January 3, 2020 updated by: Mehmet Cenk Belibağlı, Adana City Training and Research Hospital

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Adana
      • Yüreğir, Adana, Turkey, 01130
        • Adana City Training and Research Hospital Obesity Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
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.
Behavioral: Multi-disciplinary obesity management therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adana City Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2019

Primary Completion (Actual)

November 29, 2019

Study Completion (Actual)

November 29, 2019

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 14, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 6, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 483

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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