Comparing the Effectiveness of Mindfulness Intervention, Auricular Acupuncture, and Their Combined Intervention on Binge Eating Behaviors in Women with Obesity
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Protocol summary
A clinical trial with a control group with randomized parallel groups on 40 to 60 patients
A clinical trial with a control group with randomized parallel groups on 56 to 72 Volunteer.
A clinical trial with a control group with randomized parallel groups on 4056 to 60 patients72 Volunteer.
كارآزمايي باليني داراي گروه كنترل با گروه هاي موازي تصادفي بر روي 40 تا60 بيمار
كارآزمايي باليني داراي گروه كنترل با گروه هاي موازي تصادفي بر روي 56 تا 72 داوطلب
كارآزمايي باليني داراي گروه كنترل با گروه هاي موازي تصادفي بر روي 40 تا60 بيمار56 تا 72 داوطلب
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.
Issuing a call through the Comprehensive Health and Hygiene Center of District 22 in Tehran . giving individual information to overweight and obese clients through the personnel of the health center and the resident doctor of Iran Khodro Medical Center to participate in the aforementioned 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,a meeting a month later to remind and follow up, each session 120 minutes). The second group, participants will undergo auricular acupuncture intervention (8 weekly sessions, a meeting a month later to remind and follow up, each session 20 minutes). The third group, participants will also undergo auricular acupuncture intervention and will participate in mindfulness sessions (8 weekly sessions, a meeting a month later to remind and follow up, each session 150 minutes). The fourth group will be the control group, which will only have entry criteria based on body mass index and questionnaire criteria.
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 asgiving individual notificationinformation to overweight and obese visitorsclients through the staffpersonnel of the health center and the resident physiciandoctor of Iran Khodro medical centerMedical 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 mentionedaforementioned 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 sessionssessions,a meeting a month later to remind and follow up, each session 120 minutes). The second group, participants will undergo auricular acupuncture intervention (8 weekly sessions, two monthly sessionsa meeting a month later to remind and follow up, 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 sessionsa meeting a month later to remind and follow up, each session 140150 minutes). The fourth group will be the control group, which will only have entry criteria based on body mass index and questionnaire criteria.
دادن فراخوان از طريق مركز جامع سلامت و بهداشت منطقه 22 تهران به مدارس شهرک پیکان شهر . هماهنگی با مدیران مدارس پيكان شهر برای دعوت اولیای دانش آموزان به شركت در این پژوهش، هم چنین اطلاع رساني فردي به مراجعين دارای اضافه وزن و چاق از طريق پرسنل مركز بهداشت و پزشك مقيم مركز درمانی ایران خودرو براي شركت در طرح پژوهشي مذكور. پس از پر كردن پرسشنامه ها توسط داوطلبين،داوطلبين واجد شرايط بطور تصادفي در گروه هاي مختلف تقسيم بندي مي شوند . گروه اول در جلسات ذهن آگاهي خوردن (8 جلسه هفتگي ، دو جلسه ماهانههر جلسه 120 دقيقه ) شركت خواهند كرد. گروه دوم شركت كنندگان تحت مداخله طب سوزني گوش(8 جلسه هفتگي ، دو جلسه ماهانه، هر جلسه 20 دقيقه)قرار خواهند گرفت. گروه سوم شركت كنندگان هم تحت مداخله طب سوزني گوش قرار خواهند گرفت وهم در جلسات ذهن آگاهي خوردن شركت خواهند كرد(8 جلسه هفتگي ، دو جلسه ماهانه، هر جلسه 140 دقيقه) و گروه چهارم گروه كنترل خواهند بود كه تنها معيارهاي ورود را از جهت توده بدني و معيار پرسشنامه ها را دارند.
دادن فراخوان از طريق مركز جامع سلامت و بهداشت منطقه 22 تهران اطلاع رساني فردي به مراجعين دارای اضافه وزن و چاق از طريق پرسنل مركز بهداشت و پزشك مقيم مركز درمانی ایران خودرو براي شركت در طرح پژوهشي مذكور. پس از پر كردن پرسشنامه ها توسط داوطلبين،
داوطلبين واجد شرايط بطور تصادفي در گروه هاي مختلف تقسيم بندي مي شوند . گروه اول در جلسات ذهن آگاهي خوردن (8 جلسه هفتگي ، یک جلسه یک ماه بعد جهت یاد آوری و پی گیری، هر جلسه 120 دقيقه ) شركت خواهند كرد. گروه دوم شركت كنندگان تحت مداخله طب سوزني گوش(8 جلسه هفتگي ، یک جلسه یک ماه بعد جهت یاد آوری و پی گیری ، هر جلسه 20 دقيقه)قرار خواهند گرفت. گروه سوم شركت كنندگان هم تحت مداخله طب سوزني گوش قرار خواهند گرفت وهم در جلسات ذهن آگاهي خوردن شركت خواهند كرد(8 جلسه هفتگي، یک جلسه یک ماه بعد جهت یاد آوری و پی گیری، هر جلسه 150 دقيقه) و گروه چهارم گروه كنترل خواهند بود كه تنها معيارهاي ورود را از جهت توده بدني و معيار پرسشنامه ها را دارند.
دادن فراخوان از طريق مركز جامع سلامت و بهداشت منطقه 22 تهران به مدارس شهرک پیکان شهر . هماهنگی با مدیران مدارس پيكان شهر برای دعوت اولیای دانش آموزان به شركت در این پژوهش، هم چنین اطلاع رساني فردي به مراجعين دارای اضافه وزن و چاق از طريق پرسنل مركز بهداشت و پزشك مقيم مركز درمانی ایران خودرو براي شركت در طرح پژوهشي مذكور. پس از پر كردن پرسشنامه ها توسط داوطلبين،داوطلبين واجد شرايط بطور تصادفي در گروه هاي مختلف تقسيم بندي مي شوند . گروه اول در جلسات ذهن آگاهي خوردن (8 جلسه هفتگي ، دویک جلسه ماهانههریک ماه بعد جهت یاد آوری و پی گیری، هر جلسه 120 دقيقه ) شركت خواهند كرد. گروه دوم شركت كنندگان تحت مداخله طب سوزني گوش(8 جلسه هفتگي ، دویک جلسه ماهانهیک ماه بعد جهت یاد آوری و پی گیری ، هر جلسه 20 دقيقه)قرار خواهند گرفت. گروه سوم شركت كنندگان هم تحت مداخله طب سوزني گوش قرار خواهند گرفت وهم در جلسات ذهن آگاهي خوردن شركت خواهند كرد(8 جلسه هفتگي، دویک جلسه ماهانهیک ماه بعد جهت یاد آوری و پی گیری، هر جلسه 140150 دقيقه) و گروه چهارم گروه كنترل خواهند بود كه تنها معيارهاي ورود را از جهت توده بدني و معيار پرسشنامه ها را دارند.
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.
Being a woman, having a gluttonous behavior, body mass above 25, not having a serious physical or mental illness, not having a score above 29 in the Beck questionnaire.
Being a woman, having a gluttonous behavior, body mass above 25, not having a serious physical or mental illness, not beinghaving a score above 29 in the age of menopauseBeck questionnaire.
زن بودن - داشتن رفتار پرخوري - توده بدني بالاي 25- نداشتن بيماري جسمي و روحي جدي-نبودن در سن يائسگي
زن بودن - داشتن رفتار پرخوري - توده بدني بالاي 25- نداشتن بيماري جسمي و روحي جدي-نداشتن نمره بالای 29 در پرسشنامه بک
زن بودن - داشتن رفتار پرخوري - توده بدني بالاي 25- نداشتن بيماري جسمي و روحي جدي-نبودننداشتن نمره بالای 29 در سن يائسگيپرسشنامه بک
General information
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2024-09-06, 1403/06/16
2024-08-22, 1403/06/01
2024-0908-0622 00:00:00
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2024-04-21, 1403/02/02
2024-04-21 00:00:00
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2024-07-25, 1403/05/04
2024-07-25 00:00:00
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Correcting the predicted and realized number of subjects-Modification of exit criteria-Modification of evaluation periods-Modification of outcome variable conditions
Correcting the predicted and realized number of subjects-Modification of exit criteria-Modification of evaluation periods-Modification of outcome variable conditions
empty
اصلاح تعداد آزمودنی های پیش بینی شده و تحقق یافته- اصلاح معیارهای خروج - اصلاح مقاطع زمانی ارزیابی- اصلاح شرایط متغیر پیامد
اصلاح تعداد آزمودنی های پیش بینی شده و تحقق یافته- اصلاح معیارهای خروج - اصلاح مقاطع زمانی ارزیابی- اصلاح شرایط متغیر پیامد
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
Not taking psychiatric drugs
Not taking anti depresant drugs
Absence of acute physical and mental illness
A score above 29 in the Beck questionnaire
Absence of more than two sessions
Fasting diets
Not taking psychiatric drugs Not taking anti depresant drugs Absence of acute physical and mental illness Menopausal women Fasting dietsA score above 29 in the Beck questionnaire Absence of more than two sessions Fasting diets
عدم مصرف داروهاي روانپزشكي
عدم مصرف داروهاي ضد افسردگي
عدم ابتلا به بيماري حاد جسمي و رواني
زنان پسا قاعده
رژيمهاي روزه داري
غيبت بيش از دوجلسه
عدم مصرف داروهاي روانپزشكي
عدم مصرف داروهاي ضد افسردگي
عدم ابتلا به بيماري حاد جسمي و رواني
نمره بالای 29 در پرسشنامه بک
غيبت بيش از دوجلسه
رژيمهاي روزه داري
عدم مصرف داروهاي روانپزشكي عدم مصرف داروهاي ضد افسردگي عدم ابتلا به بيماري حاد جسمي و رواني زنان پسا قاعده رژيمهاي روزه دارينمره بالای 29 در پرسشنامه بک غيبت بيش از دوجلسه رژيمهاي روزه داري
Primary outcomes
#1
Before the intervention, after completing the intervention, 3 months after the intervention
Before the intervention, after completing the intervention, 1 months after the intervention
Before the intervention, after completing the intervention, 31 months after the intervention
قبل از مداخله، بعد از اتمام مداخله،3 ماه بعد از مداخله
قبل از مداخله، بعد از اتمام مداخله،1ماه بعد از مداخله
قبل از مداخله، بعد از اتمام مداخله،3 ماه1ماه بعد از مداخله
Secondary outcomes
#1
Body mass index above 27
Body mass index above 25
Body mass index above 2725
شاخص توده بدني بالاي 27
شاخص توده بدني بالاي 25
شاخص توده بدني بالاي 2725
Before the intervention, after the intervention, 3 months after the intervention
Before the intervention, after the intervention, 1 months after the intervention
Before the intervention, after the intervention, 31 months after the intervention
قبل از مداخله، بعد از مداخله، 3 ماه بعداز مداخله
قبل از مداخله، بعد از مداخله، 1 ماه بعداز مداخله
قبل از مداخله، بعد از مداخله، 31 ماه بعداز مداخله
Recruitment centers
#1
Name of recruitment center - English: Comprehensive health center of Iran Khodro clinic
Name of recruitment center - Persian: مركز جامع بهداشت و سلامت درمانگاه ايران خودرو
Full name of responsible person - English: Seid Farshad Forotan
Full name of responsible person - Persian: سيد فرشاد فروتن
Street address - English: Kilometer 14, Tehran highway, Peykanshahr town
Street address - Persian: كيلومتر 14،اتوبان تهران، شهرك پيكانشهر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1496714336
Phone: +98 21 4478 0126
Fax:
Email: dr.marziehbinesh@gmail.com
Web page address:
Name of recruitment center - English: the Comprehensive Health and Hygiene Center of Iran Khodro clinic
Name of recruitment center - Persian: مركز جامع بهداشت و سلامت درمانگاه ايران خودرو
Full name of responsible person - English: Seid Farshad Forotan
Full name of responsible person - Persian: سيد فرشاد فروتن
Street address - English: Kilometer 14, Tehran highway, Peykan Shahr Shahre
Street address - Persian: كيلومتر 14،اتوبان تهران، شهرك پيكانشهر
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1496714336
Phone: +98 21 4478 0126
Fax:
Email: dr.marziehbinesh@gmail.com
Web page address:
Name of recruitment center - English: the Comprehensive health centerHealth and Hygiene Center of Iran Khodro clinic Name of recruitment center - Persian: مركز جامع بهداشت و سلامت درمانگاه ايران خودرو Full name of responsible person - English: Seid Farshad Forotan Full name of responsible person - Persian: سيد فرشاد فروتن Street address - English: Kilometer 14, Tehran highway, Peykanshahr townPeykan Shahr Shahre Street address - Persian: كيلومتر 14،اتوبان تهران، شهرك پيكانشهر City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1496714336 Phone: +98 21 4478 0126 Fax: Email: dr.marziehbinesh@gmail.com Web page address:
Protocol summary
Study aim
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 56 to 72 Volunteer.
Settings and conduct
Issuing a call through the Comprehensive Health and Hygiene Center of District 22 in Tehran . giving individual information to overweight and obese clients through the personnel of the health center and the resident doctor of Iran Khodro Medical Center to participate in the aforementioned 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,a meeting a month later to remind and follow up, each session 120 minutes). The second group, participants will undergo auricular acupuncture intervention (8 weekly sessions, a meeting a month later to remind and follow up, each session 20 minutes). The third group, participants will also undergo auricular acupuncture intervention and will participate in mindfulness sessions (8 weekly sessions, a meeting a month later to remind and follow up, each session 150 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 having a score above 29 in the Beck questionnaire.
Intervention groups
Mindfulness, ear acupuncture, integrated intervention, control
Main outcome variables
Improving eating behaviors, weight loss
General information
Reason for update
Correcting the predicted and realized number of subjects-Modification of exit criteria-Modification of evaluation periods-Modification of outcome variable conditions
Acronym
IRCT registration information
IRCT registration number:IRCT20240307061209N1
Registration date:2024-04-10, 1403/01/22
Registration timing:prospective
Last update:2024-07-27, 1403/05/06
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
2024-08-22, 1403/06/01
Actual recruitment start date
2024-04-21, 1403/02/02
Actual recruitment end date
2024-07-25, 1403/05/04
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
A score above 29 in the Beck questionnaire
Absence of more than two sessions
Fasting diets
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:
72
Actual sample size reached:
56
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
Unit 42, Haraz St.Hirmand St., Jozani Gharbi St., Persian Gulf Lake Square., B2 Yas Tower
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, 1 months after the intervention
Method of measurement
Dutch questionnaire
Secondary outcomes
1
Description
Body mass index above 25
Timepoint
Before the intervention, after the intervention, 1 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
the Comprehensive Health and Hygiene Center of Iran Khodro clinic
Full name of responsible person
Seid Farshad Forotan
Street address
Kilometer 14, Tehran highway, Peykan Shahr Shahre
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