Determining the effect of attention bias modification in overweight or obese people
Design
In this clinical trial study with parallel groups, 40 patients aged 18-60 years with BMI> 25 were randomly divided into intervention and control groups. In the intervention group, patients received metformin 2000 mg/day with correction of bias and the control group received metformin 2000 mg/day alone.
Settings and conduct
This is a clinical trial study with parallel groups. In this study, 40 patients aged 18-60 years with BMI> 25 were randomly divided into intervention and control groups. In the intervention group, patients received metformin 2000 mg/day with bias correction, and in the control group, metformin 2000 mg/day was given alone. Then the two groups are evaluated for attention bias, BMI, and food cravings at the beginning of the study at intervals of 12 and 24 weeks.
Participants/Inclusion and exclusion criteria
inclusion criteria: Age 18-60 years, BMI over 25
Non-entry criteria: concomitant medical disorder, use of medication during the course, decreased level of consciousness
Intervention groups
The intervention group received metformin 2000 mg daily (metformin becomes tolerable for a period of 3 weeks to 2 grams per day) and the correction of attention bias was obtained by point search software and the control group received metformin 2000 mg daily.
Main outcome variables
Attention bias, BMI, food cravings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191104045328N5
Registration date:2021-03-04, 1399/12/14
Registration timing:registered_while_recruiting
Last update:2021-03-04, 1399/12/14
Update count:0
Registration date
2021-03-04, 1399/12/14
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-04, 1399/12/14
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of attention bias correction in overweight or obese people
Public title
Investigating the effect of attention bias correction on weight loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years
BMI > 25
Exclusion criteria:
History of liver disease or kidney failure
Use of medication during the course
Loss of consciousness
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are assigned to two intervention and control groups, respectively, based on the randomization sequence that will be generated beforehand. This sequence is unpredictable and its arrangement is completely random. Block randomization method with 8 blocks will be used to allocate samples. Thus, using block numerical random number generation software, a randomization sequence proportional to the sample size required for the two groups will be generated. Initially, all cases in which the two letters A and B can be arranged in blocks of 8 are produced. A block is then randomly selected from the blocks and the layout pattern in that block will be used to assign participants. This block will then be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups. In fact, the researcher will not be able to predict which group the next person will be in.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-05-03, 1399/02/14
Ethics committee reference number
IR.ARAKMU.REC.1399.038
Health conditions studied
1
Description of health condition studied
Obesity and overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Attention bias
Timepoint
Beginning of the study - End of the study
Method of measurement
Dot-probe test
2
Description
Food cravings
Timepoint
Beginning of the study - 12th week - 24th week
Method of measurement
using Fcod Craving Questionnaire-Trait
3
Description
Bone Mass Index
Timepoint
Beginning of the study - 12th week - 24th week
Method of measurement
Tape meter and scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients received metformin 2000 mg/day with correction of bias . Attention bias correction includes ten 30-minute sessions that are performed three times a week. Each session includes exercises for paying attention to neutral images. For this purpose, 100 pairs of emotional and neutral images are used.Each pair of images is presented to the subject for 500 milliseconds, then the images disappear immediately and a cross appears instead of a neutral image on the screen, and the subject must press a key in the same direction as the neutral image.This action causes the subject to pay attention to neutral images and to turn his attention away from obsessive emotional images as a result of repeating the exercise.
Category
Treatment - Devices
2
Description
Control group: Patients are given metformin 2000 mg daily
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Amirkabir hospital
Full name of responsible person
Dr Mostafa Nokani
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
m.nokani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Vice chancellor for Research, Arak University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mostafa Nokani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
nokani@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mehran Shayeganfard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
mshayganfard@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Shokouh Sadat Farzaneh Dehkordi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
amin.medstu@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When the article was out of print.
When the data will become available and for how long
After publishing the article
To whom data/document is available
University researchers
Under which criteria data/document could be used
If there are any further questions
From where data/document is obtainable
Dr Mostafa Nokani
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.