Comparison of the effectiveness of Emotion-Focused Group Therapy and Diet Therapy Combined with Exercise on Impulse Control, Night Eating Syndrome and Difficulty in Emotion Regulation in Obese people with Binge Eating Disorder
Determining the difference in the effectiveness of the diet therapy with aerobic exercise and its combined effect with the Emotion Focused Group Therapy on impulse control, Night eating syndrome and Difficulty in emotional regulation of obese people with Binge eating disorder.
Design
The clinical trial has a control group, with parallel groups, a blind strain, randomized, the considered sample size is 54 people. Sampling was done using block method.
Settings and conduct
EFGT consists of 10 sessions that will be implemented for one of the groups. Both intervention groups will receive the intervention diet therapy with exercise, and the place will be performed in the Obesity clinic of Sina Hospital. Single blind and the participants without knowing the type of intervention were divided into intervention and control groups.
Participants/Inclusion and exclusion criteria
Entry conditions include: body mass index above 30, no addiction to drugs and alcohol, diagnosis of binge eating disorder, no psychological disorder other than binge eating disorder; Non-entry conditions include: body mass index below 30, not filling informed consent.
Intervention groups
The first group (emotion-focused group intervention and diet therapy combined with exercise): the emotion-focused therapy is based on the intervention provided by Greenberg (2015), the structure of the EFT sessions includes 10 two-hour sessions that are performed weekly. The second group: The intervention is based on diet therapy combined with exercise. The third group (control group) does not receive any intervention.
Main outcome variables
Help to treat obesity with binge eating disorder; impulse control; improvement of Night eating syndrome; Emotion regulation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220218054053N1
Registration date:2022-11-10, 1401/08/19
Registration timing:retrospective
Last update:2022-11-10, 1401/08/19
Update count:0
Registration date
2022-11-10, 1401/08/19
Registrant information
Name
Mir Javad Chehraghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4464 5096
Email address
javi_422@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-01, 1401/06/10
Expected recruitment end date
2022-10-02, 1401/07/10
Actual recruitment start date
2022-09-13, 1401/06/22
Actual recruitment end date
2022-10-04, 1401/07/12
Trial completion date
2023-02-12, 1401/11/23
Scientific title
Comparison of the effectiveness of Emotion-Focused Group Therapy and Diet Therapy Combined with Exercise on Impulse Control, Night Eating Syndrome and Difficulty in Emotion Regulation in Obese people with Binge Eating Disorder
Public title
Effectiveness of Emotion Focused Group Therapy in Obese people with Binge Eating Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent in research
Age range 30 to 55 years
Body mass index above 30
Absence of drugs and alcoholic beverages addiction (According to the comments of the participants in the research and their medical records in the Obesity clinic of Sina Hospital
Obtaining a diagnosis of Binge Eating Disorder based on the medical records available in the Obesity clinic of Sina Hospital
No received psychological disorders other than Binge Eating Disorder based on medical records in the Obesity Clinic of Sina Hospital
Exclusion criteria:
Body mass index under 30
People with Bulimia Nervosa
Age
From 30 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
54
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The sample people were assigned in three groups (including two intervention groups and one control group) by block randomization method. Randomization was done using the website https://www.sealedenvelope.com/. According to the number of groups (3 groups), the size of the blocks was considered 6 and it is fixed. A total of 9 blocks were obtained. Thus, in each block, 2 people were assigned to the first intervention group, 2 people to the second intervention group, and 2 people to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Interventions of the intervention and control group are kept blind without the subjects knowing about the control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Karaj Branch
Street address
Cross at esteghlal and Moazen Blvd, Rajaii shahr
City
karaj
Province
Tehran
Postal code
3149968111
Approval date
2022-08-31, 1401/06/09
Ethics committee reference number
IR.IAU.K.REC.1401.090
Health conditions studied
1
Description of health condition studied
Obesity with Binge eating disorder
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Obesity, which is calculated by measuring the body mass index; Impulse control by Bart Impulsivity Questionnaire; Night eating syndrome by the Night Eating Questionnaire (NEQ) by Allison et al. (2008); Emotion regulation by the scale of difficulty in emotion regulation (Gertz and Roemer, 2004).
Timepoint
The time periods of measurement are at the beginning of the trial, second time after the completion of the interventions and third time two months after the completion of the interventions.
Method of measurement
Obesity, which is calculated by measuring the body mass index (BMI) using a scale and height measurement tool based on meters, which should be above 30; Impulse control by Bart Impulsivity Questionnaire; Night eating syndrome by the Night Eating Questionnaire (NEQ) by Allison et al. (2008); Emotion regulation by the scale of difficulty in emotion regulation (Gertz and Roemer, 2004).
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group (group intervention focused on emotion and diet therapy combined with exercise): The intervention focused on emotion in the present study is carried out using the intervention sessions provided by Greenberg (2015) and includes 10 two-hour sessions that are implemented weekly. In short, the sessions include awareness of emotions, emotional experience, and reaching primary maladaptive emotions and changing them to primary adaptive emotions.
Category
Treatment - Other
2
Description
The second intervention group: In this research, it includes diet therapy along with aerobic exercise, the amount of calories needed by all clients in this group and the first group was calculated according to height, age, and gender, and the daily diet was reduced by 500 kilo-calories. With the share of 60-65% carbohydrates, 20-25% protein and the rest fat was prescribed, 30-45 minutes of aerobic exercise such as moderate intensity walking was considered daily. Weighing and determination of body mass index were done before and after. Seka scale is used as a standard scale.
Category
Treatment - Other
3
Description
Control group: Control group does not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Maryam Abolhasani
Street address
No. 150, Entrance 14, Block A2, Phase 1, Ekbatan Town