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IRCT20210507051204N2 IRCT 2024-01-09 Esfahan University of Medical Sciences Investigating the effectiveness of mindfulness on the food craving trait Investigating and comparing the effectiveness of a mindfulness-based intervention along with standard treatment compared to standard treatment alone on the food craving trait in overweight and obese individuals with mild to moderate anxiety and/or depression: a randomized controlled trial. 2024-05-21 anticipated 60 Complete https://irct.ir/trial/74608 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Stratified randomization will be done in blocks with blocks of 4, where the strata are obesity and overweight. The order of assigning people to groups will be determined based on the list generated by "Random Allocation" software, and people will be assigned to one of two intervention or control groups based on this list. The main interventionist is not aware of the order created by this list, and after the decision to enter a person into the study, the list is checked by another researcher, who then informs the main researcher of the individual's group. N/A Overweight and obesity. Intervention 1: Control group: will receive standard treatment, which includes a normal caloric restriction diet tailored to the individual, which is determined by a nutritionist based on factors such as the individual's nutritional status, degree of overweight and obesity, and underlying diseases. Intervention 2: Intervention group: In addition to the standard treatment, will receive a 14-day course including audio files of maximum 10-15 minutes including training related to mindfulness and mindful eating. Participants will be asked to listen to these files daily and apply the skills taught throughout the day. The educational topics will include a concept section and a mindful eating section. Topics in the concepts section include Mindfulness-introduction, Present moment awareness, Acceptance and non-judgment, Body scan, Decentralization, Beginner's mind, Gratitude and Self-acceptance. Topics in the Mindful Eating section include Mindful Eating-Introduction, Mindful snack, Connection to Food, Types of Hunger, Satiety Cues, and Coping with Food Cravings. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after individuals were unidentified When: After results publication To whom: Everyone Conditions: For further studies Where to obtain: Dr. Zeinab Mokhtari, Assistant Professor of Nutritional Sciences, Food Security Research Center, Isfahan University of Medical Sciences E-mail: mokhtari@nutr.mui.ac.ir How to obtain: Contacting Dr. Zeinab Mokhtari via email Comments:
public Seyed Amirhossein Allameh
Nutrition and Food Security Research Center, Faculty of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hazarjarib Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3179 sahallameh@gmail.com Esfahan University of Medical Sciences scientific Zeinab Mokhtari
Nutrition and Food Security Research Center, Faculty of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hazarjarib Street
اصفهان Iran (Islamic Republic of) 8174673461 +98 31 3792 3183 zeinab_mokhtary@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) BMI>=25 Mild to moderate anxiety or depression: according to the DASS-21 questionnaire, a score of 7 to 12 in men and 9 to 14 in women for the depression subscale, or a score of 6 to 11 in men and 8 to 12 in women for the anxiety subscale Access to a smart phone and the ability to use it to receive and use the files related to study Having sufficient literacy (reading and writing) to complete forms and questionnaires Living in Isfahan city or nearby towns and villages Willingness to participate in the study 18 years 65 years Both Being a candidate for bariatric surgery History of bariatric surgery in the last 18 months Age less than 18 or more than 65 years Having mental disabilities, blindness or deafness Being treated in other centers or participating in other similar studies Having a history of acute psychological diseases such as major depression, bulimia, anorexia, suicide or suicidal thoughts, schizophrenia, acute personality disorders, severe anxiety and depression, panic disorder and drug addiction. History of hospitalization due to psychological diseases History of diseases affecting appetite and weight gain/loss such as hypo/hyperthyroidism, liver cirrhosis, uncontrolled metabolic diseases, immune diseases and malignancy Taking drugs that have a significant effect on metabolism or appetite, such as corticosteroids, psychiatric drugs, and hormonal drugs Previous familiarity with and regular use of mindfulness-based techniques (more than or equal to three times a week, each time 10 minutes or more) Pregnant or lactating women Not willing to participate in the study or withdrawing from cooperation at any stage of the study E66 Overweight and obesity Treatment - Other Other Control group: will receive standard treatment, which includes a normal caloric restriction diet tailored to the individual, which is determined by a nutritionist based on factors such as the individual's nutritional status, degree of overweight and obesity, and underlying diseases. Intervention group: In addition to the standard treatment, will receive a 14-day course including audio files of maximum 10-15 minutes including training related to mindfulness and mindful eating. Participants will be asked to listen to these files daily and apply the skills taught throughout the day. The educational topics will include a concept section and a mindful eating section. Topics in the concepts section include Mindfulness-introduction, Present moment awareness, Acceptance and non-judgment, Body scan, Decentralization, Beginner's mind, Gratitude and Self-acceptance. Topics in the Mindful Eating section include Mindful Eating-Introduction, Mindful snack, Connection to Food, Types of Hunger, Satiety Cues, and Coping with Food Cravings. Food craving-trait score from FCQ-T-r questionnaire. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: FCQ-T-r questionnaire. Binge eating. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: Binge eating scale questionnaire. Anxiety level. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: Anxiety subscale of 21 question version of depression-anxiety-stress scale questionnaire. Depression level. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: Depression subscale of 21 question version of depression-anxiety-stress scale questionnaire. Mindful eating level. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: Mindful-Eating questionnaire. Mindfulness level. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: Philadelphia mindfulness scale questionnaire. Satisfaction level regarding the therapy. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: visual analogue scale. Body mass index. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: weight in kilograms divided by height in meters squared. Weight. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: body analyzer. Body composition. Timepoint: The beginning of the study (before the start of the intervention), 2, 6, 10 and 14 weeks after starting to use the audio files. Method of measurement: body analyzer. Esfahan University of Medical Sciences Approved 2024-01-03 Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Sciences and Health Services, Hezar Jarib Ave. اصفهان Isfehan Iran (Islamic Republic of)