Comparing the Effectiveness of Mindfulness Intervention, Auricular Acupuncture, and Their Combined Intervention on Binge Eating Behaviors in Women with Obesity
Comparison of mindfulness with auricular acupuncture on eating behavior in obese women.
Design
A clinical trial with a control group with randomized parallel groups on 40 to 60 patients
Settings and conduct
Issuing a call through the Comprehensive Health and Hygiene Center of District 22 in Tehran . Coordination with the principals of Peykan city schools to invite students' parents to participate in this research, as well as individual notification to overweight and obese visitors through the staff of the health center and the resident physician of Iran Khodro medical center to participate in the mentioned research project, individual notification to overweight visitors through the staff of the health center and the resident physician of the Iran Khodro Clinic to participate in the mentioned research project. After filling out the questionnaires by the volunteers, eligible volunteers will be randomly divided into different groups. The first group will participate in mindfulness sessions (8 weekly sessions, two monthly sessions, each session 120 minutes). The second group, participants will undergo auricular acupuncture intervention (8 weekly sessions, two monthly sessions, each session 20 minutes). The third group, participants will also undergo auricular acupuncture intervention and will participate in mindfulness sessions (8 weekly sessions, two monthly sessions, each session 140 minutes). The fourth group will be the control group, which will only have entry criteria based on body mass index and questionnaire criteria.
Participants/Inclusion and exclusion criteria
Being a woman, having a gluttonous behavior, body mass above 25, not having a serious physical or mental illness, not being in the age of menopause.
Intervention groups
Mindfulness, ear acupuncture, integrated intervention, control
Main outcome variables
Improving eating behaviors, weight loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240307061209N1
Registration date:2024-04-10, 1403/01/22
Registration timing:registered_while_recruiting
Last update:2024-04-10, 1403/01/22
Update count:1
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
Marzieh Binesh
Name of organization / entity
Alzahra university
Country
Iran (Islamic Republic of)
Phone
+98 21 4477 0491
Email address
m.binesh@alzahra.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-09-06, 1403/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Mindfulness Intervention, Auricular Acupuncture, and Their Combined Intervention on Binge Eating Behaviors in Women with Obesity
Public title
Comparison of the effect of mindfulness with acupuncture on binge eating behaviors in obese women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
being a woman
Having binge eating behavior
Having Bing eating disorder
BMI over 25
Consent to participate in research
Exclusion criteria:
Not taking psychiatric drugs
Not taking anti depresant drugs
Absence of acute physical and mental illness
Menopausal women
Fasting diets
Absence of more than two sessions
Age
From 25 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using random allocation software and a block method with random blocks.
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
Research Ethics Committees of Alzahra University
Street address
Unit42,B2 Yas Tower,Haraz St.Hirmand St.Jozani Gharbi St.Persian Gulf Lake Square
City
Tehran
Province
Tehran
Postal code
1495848592
Approval date
2024-01-03, 1402/10/13
Ethics committee reference number
IR.ALZAHRA.REC.1402.078
Health conditions studied
1
Description of health condition studied
Bing eating behavior
ICD-10 code
F90-98
ICD-10 code description
Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
Primary outcomes
1
Description
A higher than average score in the subscales of the Dutch questionnaire in eating behaviors (emotional eating, external eating, restrained eating)
Timepoint
Before the intervention, after completing the intervention, 3 months after the intervention
Method of measurement
Dutch questionnaire
Secondary outcomes
1
Description
Body mass index above 27
Timepoint
Before the intervention, after the intervention, 3 months after the intervention
Method of measurement
Use of scales and height gauges
Intervention groups
1
Description
minfulness
Category
Treatment - Other
2
Description
auricular acupuncture
Category
Treatment - Other
3
Description
auricular acupuncture- minfulness
Category
Treatment - Other
4
Description
Control group:
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health center of Iran Khodro clinic
Full name of responsible person
Seid Farshad Forotan
Street address
Kilometer 14, Tehran highway, Peykanshahr town
City
Tehran
Province
Tehran
Postal code
1496714336
Phone
+98 21 4478 0126
Email
dr.marziehbinesh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research and Technology of Al-Zahra University, Al-Zahra University
Full name of responsible person
Fakhri Sadat Hosseini
Street address
Al Zahra University
City
Tehran
Province
Tehran
Postal code
1993891176
Phone
+98 21 8569 2202
Email
f.hosseini@alzahra.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research and Technology of Al-Zahra University, Al-Zahra University
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
Alzara university
Full name of responsible person
marzieh Binesh
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 42, Haraz St.Hirmand St., Jozani Gharbi St., Persian Gulf Lake Square.,B2 Yas Tower
City
Tehran
Province
Tehran
Postal code
1495848592
Phone
009844770491
Email
M.Binesh@alzahra.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Marzieh Binesh
Position
PHD student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 42, Haraz St.Hirmand St., Jozani Gharbi St., Persian Gulf Lake Square.,B2 Yas Tower
City
Tehran
Province
Tehran
Postal code
1495848592
Phone
+98 21 4477 0491
Email
dr.marziehbinesh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Alzara University
Full name of responsible person
Marzieh Binesh
Position
PHD student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Unit 42, Haraz St.Hirmand St., Jozani Gharbi St., Persian Gulf Lake Square.,B2 Yas Tower
City
Tehran
Province
Tehran
Postal code
14958488592
Phone
+98 21 4477 0491
Email
dr.marziehbinesh@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
All personal data can be shared after de-identifying individuals
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
All researchers working in academic and scientific and health institutions
Under which criteria data/document could be used
Non identifiable data will be accessible in case of correspondence with the main executive and for research purposes and to improve the physical and mental health of the community.
From where data/document is obtainable
To receive the desired data, applicants can contact Dr. Marzieh Binesh by email at dr.marziehbinesh@gmail.com or by phone at 0098 9125062059.
What processes are involved for a request to access data/document
Maximum two weeks after sending the request, the data will be sent to them