Protocol summary

Study aim
The aim of this study was to compare of the effectiveness of attachment-based intervention and dialectical behavior therapy on emotion regulation, food response styles, food cravings and bmi in obese students
Design
Clinical trial with control group, with parallel groups, double-blind, randomized
Settings and conduct
The experimental groups of this study were trained in ruby counseling center in Sari. The method was group work, blinding was not performed in this study. The interventions were performed by psychiatrists in experimental groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Includes body mass index above 30 Do not take psychiatric medications No history of receiving psychological interventions in the field of obesity Age range 13 to 15 years Exclusion criteria: Absence of more than one session of treatment sessions
Intervention groups
The first intervention group includes students with obesity who receive Attachment-Based Intervention. The second intervention group includes students with obesity who receive dialectical behavioral therapy. The control group includes obese students who do not receive intervention
Main outcome variables
Evaluation of Consumption cravings using obesity cravings questionnaire (trait form), Food Response Styles Evaluation Using Food Response Styles Scale, Emotion Regulation Evaluation Using Difficulty in Emotion Regulation, Three Stages of Evaluation at the Beginning of Intervention, The intervention was completed.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200405046962N1
Registration date: 2020-04-19, 1399/01/31
Registration timing: retrospective

Last update: 2020-04-19, 1399/01/31
Update count: 0
Registration date
2020-04-19, 1399/01/31
Registrant information
Name
Farshid alipour
Name of organization / entity
Kharazmi University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 81 3421 0573
Email address
alipoorfarshid@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
2019-11-11, 1398/08/20
Actual recruitment end date
2020-02-14, 1398/11/25
Trial completion date
2020-02-14, 1398/11/25
Scientific title
Comparison of the Effectiveness of Attachment-Based Intervention and Dialectical Behavior Therapy on Emotion Regulation, Food Response Styles, Food Cravings and BMI in Obese Students
Public title
The effect of psychological training in the treatment of obesity
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
body mass index above 30, Do not take psychiatric medications, No history of receiving psychological interventions in the field of obesity, Age range 13 to 15 years
Exclusion criteria:
Absence of more than two sessions of treatment sessions
Age
From 13 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
An random assignment was made in which all the subjects name were poured into a container and a name was randomly removed from the container. Then, to determine this person's intervention method, the name of the intervention method (dialectical, attachment and control) was randomly removed from another container.
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
Islamic Azad University, Sari Branch
Street address
darya
City
sari
Province
Mazandaran
Postal code
19318-48161
Approval date
2019-11-06, 1398/08/15
Ethics committee reference number
IR.IAU.SARI.REC.1398.208

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calorie

Primary outcomes

1

Description
body Mass index
Timepoint
Pre-test and post-test in study groups
Method of measurement
it measured by dividing the weight in kilograms by the square of its height in meters (m2) was calculated.

2

Description
Food Cravings
Timepoint
Pre-test and post-test in study groups
Method of measurement
food cravings Questionnaires

3

Description
food response styles
Timepoint
Pre-test and post-test in study groups
Method of measurement
food response styles Scale

4

Description
emotion regulation
Timepoint
Pre-test and post-test in study groups
Method of measurement
Difficult questionnaire in emotion regulation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Attachment-based treatment. Attachment-Based Learning Outcomes A combined and therapeutic understanding of the mother-of-child sensitization principles, appropriate responses to the child, the basics of empathetic behavior with the mother, and Atkinson's relationship (2000) were taught in ten ninety-minute sessions according to the following content: First session: Introduction, Introducing programs and contracts. Session 2: The need to recognize the emotions of adolescents, teaching the art of mother availability, the art of screenwriting. Session 3: Communication with Adolescents, Verbal Communication Techniques with Adolescents, Storytelling Techniques. Third and fourth sessions: Restoring a sense of distrust in teens, how to show affection to teens. Session 5 and 6: Increasing the positive interaction of the adolescent mother and avoiding coercion, identifying the signs of anger and aggression in the adolescent and managing it. Session 7 and 8: Stress management, review of adolescent unresolved behavioral issues. Ninth and tenth sessions: spectator parenting techniques on emotional overeating behaviors, differentiating positive behaviors, and ultimately summarizing, concluding, and performing post-test.
Category
Behavior

2

Description
Intervention group: dialectical behavioral therapy. Subjects were taught one group of dialectical behavioral therapies per week according to the following content: First session: Introduction, introduction of programs and contracts, introduction of treatment logic and pre-test implementation, second session: definition of dialectics, principles and their aftermath. Mental, Third Session: Institutional Mind Training (Emotional Awareness and Wise Consciousness), Third and Fourth Session: Teaching Endurance Training (Crisis Sustainability Skills, Distracting the Minds, Relieving the Self by Using Six Senses and Practicing Awareness) Sixth: Teaching the acceptance of distress and moderation of emotions, including types of R. Emotional Effects, Consequences and Benefits of Each Strategy, Seventh and Eighth Sessions: How to Treat Food and Imagination of the Body, Learning About Eating, Balanced Eating, Different Nutrition, Ninth and Tenth Meetings: Learning Emotion Regulation Learning Emotions, Knowing Why Emotions It is important to recognize the emotion, reduce the vulnerability and emotional excitement, increase the positive emotion and summarize the sessions and review the content provided.
Category
Behavior

3

Description
Control group: Control group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Sari High School
Full name of responsible person
fateme sadri
Street address
emam
City
sari
Province
Mazandaran
Postal code
65345-57623
Phone
+98 31 5358 0082
Fax
Email
psychology2020ali@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Islamic Azad University, Sari Branch
Street address
sari
City
sari
Province
Mazandaran
Postal code
19318-48161
Phone
+98 51 1213 2891
Fax
Email
info@iausari.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
There was no financial prohibition
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahrbanoo Dehrouyeh
Position
Ph.D. in Educational Psychology, Department of Psychology, Faculty of humanities, Islamic Azad Unive
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
darya
City
sari
Province
Mazandaran
Postal code
19318-48161
Phone
+98 51 1213 2891
Email
psychology2020ali@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahrbanoo Dehrouyeh
Position
Ph.D. in Educational Psychology, Department of Psychology, Faculty of humanities, Islamic Azad Unive
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
darya
City
sari
Province
Mazandaran
Postal code
19318-48161
Phone
+98 51 1213 2891
Email
psychology2020ali@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shahrbanoo Dehrouyeh
Position
Ph.D. in Educational Psychology, Department of Psychology, Faculty of humanities, Islamic Azad Unive
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
darya
City
sari
Province
Mazandaran
Postal code
19318-48161
Phone
+98 51 1213 2891
Email
psychology2020ali@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Statistical findings can be published
When the data will become available and for how long
2020
To whom data/document is available
Students and psychologists
Under which criteria data/document could be used
Research and training
From where data/document is obtainable
Email the responsible author
What processes are involved for a request to access data/document
Replies after email
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