Protocol summary

Study aim
Determining the effect of EFT method on the feeling of "craving" in overweight and obese clients of Imam Ali Shahrekord Clinic in 1402-1403
Design
A clinical trial with a control group, one blind strain, randomized, two groups of 17 people
Settings and conduct
40 patients of the Imam Ali Clinic in Shahrekord were voluntarily divided into two groups and at the same time pre-examination and weight loss recommendations were given to the people (without providing a diet). EFT is presented to the experimental group during 8 sessions. Every two weeks and in the last session for the purpose of the post-test and also after four weeks to follow up the effectiveness of the treatment, the final questionnaire is completed by the participants. In order to blind the researcher, pre-test and post-test questionnaires with specific numerical codes are given to the person who intends to score them.
Participants/Inclusion and exclusion criteria
Referees to Imam Ali Shahrekord clinic/age over 19 years/willingness to participate in the study/BMI over 25 Not having obvious mental illnesses such as specific mood disorders, depression based on the GHQ questionnaire / not suffering from severe liver disease, diabetes and kidney problems ; Failure to comply with the project protocol, suffering from any disease or disorder during the study that prevents the patient from implementing the study protocol.
Intervention groups
EFT is performed during 8 sessions, one session per week, for the experimental group; to rate the effect of EFT on their cravings. The final questionnaire is completed every two weeks and the last session for the purpose of the post-test and four weeks later to follow up the effectiveness of the treatment.
Main outcome variables
cravings; anthropometric indicators

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230823059243N1
Registration date: 2024-01-18, 1402/10/28
Registration timing: prospective

Last update: 2024-01-18, 1402/10/28
Update count: 0
Registration date
2024-01-18, 1402/10/28
Registrant information
Name
Zahra Sayadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3335 9091
Email address
z7sayadi7@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-06-04, 1403/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Examining the effect of EFT (Emotional Freedom Technique) on the feeling of "craving" (Food)Craving (in overweight and obese clients
Public title
Examining the effect of EFT (Emotional Freedom Technique) on the feeling of "craving" (Food)Craving (in overweight and obese clients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Referring to Imam Ali Clinic Shahrekord Willingness to participate in the study BMI above 25 No obvious mental illnesses such as certain mood disorders, depression based on GHQ mental health questionnaire Lack of severe liver disease (liver failure), diabetes and kidney problems Aga over 19 years
Exclusion criteria:
Severe liver disease (liver failure), diabetes and kidney problems Not having an acceptable score based on GHQ Mental Health Questionnaire Risk of imminent suicide and any substance abuse or alcohol dependence
Age
From 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
By using the simple random sampling method: in this way, a list of the names of the people who will finally enter the study based on the entry and exit criteria is prepared, in the prepared list, a number will be assigned to the names of each person. . The number assigned to each person is written on a piece of paper. All the papers are put in a container and mixed together. Then the papers are randomly selected from the container and the first number is assigned to the intervention group and the second number is assigned to the control group. The work will proceed in the same order until the end. Then, based on the selected numbers, the list of names of the intervention and control groups is determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the researcher who intends to score the pre-test and post-test of the participants in the study, for blinding, the questionnaires along with the demographic characteristics of the participants are refrained from presenting, in this process the pre-test and post-test questionnaires with numerical codes. specified and given to the person who intends to grade them. Therefore, this person will be unaware of the individual characteristics of each questionnaire and specific group (intervention or control).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahr e kord University of Medical Sciences
Street address
kashani
City
Shahr e kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2024-01-03, 1402/10/13
Ethics committee reference number
IR.SKUMS.MED.REC.1402.081

Health conditions studied

1

Description of health condition studied
Obesity and overweight
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Food craving score in the food craving questionnaire
Timepoint
The score of the questionnaire before the exam and every two weeks and 4 weeks after the completion of the study
Method of measurement
food craving questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: EFT with an emotion-oriented treatment approach is provided in 8 weekly sessions for the experimental group in the weight loss clinic.
Category
Behavior

2

Description
Control group: Weight loss recommendations are given to all participants based on WHO criteria, and like the intervention group, the food craving questionnaire is also completed by this group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized Clinic of Imam Ali (AS) Shahrekord
Full name of responsible person
Zahra Sayadi
Street address
Shariati Blv.,Iman Ali(A.S.)Specialized Clinic
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815966918
Phone
+98 38 3224 2696
Email
z7sayadi7@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Elham Raeesi
Street address
Kashani Blv.,University Headquarters
City
Sharekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3334 2414
Email
z7sayadi7@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Sayadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
No4, Baharestan Ave , Khalifabad Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815966918
Phone
+98 913 606 0490
Email
z7sayadi7@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Sayadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
No4, Baharestan Ave , Khalifabad Street
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815966918
Phone
+98 913 606 0490
Email
z7sayadi7@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Zahra Sayadi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
No4, Baharestan Ave , Khalifabad Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815966918
Phone
+98 913 606 0490
Email
z7sayadi7@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
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