Protocol summary
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Study aim
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Comparison of mindfulness with auricular acupuncture on eating behavior in obese women.
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Design
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A clinical trial with a control group with randomized parallel groups on 56 to 72 Volunteer.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Mindfulness, ear acupuncture, integrated intervention, control
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Main outcome variables
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Improving eating behaviors, weight loss
General information
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Reason for update
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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
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Acronym
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IRCT registration information
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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
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Registration date
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2024-04-10, 1403/01/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-04-03, 1403/01/15
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Expected recruitment end date
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2024-08-22, 1403/06/01
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Actual recruitment start date
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2024-04-21, 1403/02/02
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Actual recruitment end date
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2024-07-25, 1403/05/04
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Trial completion date
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empty
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Scientific title
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Comparing the Effectiveness of Mindfulness Intervention, Auricular Acupuncture, and Their Combined Intervention on Binge Eating Behaviors in Women with Obesity
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Public title
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Comparison of the effect of mindfulness with acupuncture on binge eating behaviors in obese women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 50 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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No information
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Sample size
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Target sample size:
72
Actual sample size reached:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done using random allocation software and a block method with random blocks.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-01-03, 1402/10/13
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Ethics committee reference number
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IR.ALZAHRA.REC.1402.078
Health conditions studied
1
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Description of health condition studied
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Bing eating behavior
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ICD-10 code
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F90-98
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ICD-10 code description
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Behavioural and emotional disorders with onset usually occurring in childhood and adolescence
Primary outcomes
1
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Description
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A higher than average score in the subscales of the Dutch questionnaire in eating behaviors (emotional eating, external eating, restrained eating)
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Timepoint
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Before the intervention, after completing the intervention, 1 months after the intervention
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Method of measurement
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Dutch questionnaire
Secondary outcomes
1
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Description
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Body mass index above 25
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Timepoint
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Before the intervention, after the intervention, 1 months after the intervention
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Method of measurement
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Use of scales and height gauges
Intervention groups
1
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Description
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minfulness
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Category
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Treatment - Other
2
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Description
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auricular acupuncture
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Category
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Treatment - Other
3
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Description
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auricular acupuncture- minfulness
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Category
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Treatment - Other
4
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Description
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Control group:
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice President of Research and Technology of Al-Zahra University, Al-Zahra University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All personal data can be shared after de-identifying individuals
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When the data will become available and for how long
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Immediately after the publication of the article
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To whom data/document is available
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All researchers working in academic and scientific and health institutions
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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To receive the desired data, applicants can contact Dr. Marzieh Binesh by email at dr.marziehbinesh@gmail.com or by phone at 0098 9125062059.
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What processes are involved for a request to access data/document
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Maximum two weeks after sending the request, the data will be sent to them
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Comments
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