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IRCT20180201038585N8 IRCT 2020-10-28 Bagheiat-allah University of Medical Sciences Effect of Mediterranean diet on weight and psychological disorders The effects of Mediterranean diet instruction on anthropometric indices, depression, anxiety and stress disorders and their relationship with healthy lifestyle score: A randomized double-blind controlled clinical trial 2020-10-03 anticipated 60 Complete https://irct.ir/trial/51630 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization was performed by block randomization method. Random sequence generation was done using table of random numbers by a third trained person. Allocation concealment was performed using sealed envelopes, Blinding description: Intervention and assignment was performed by a third trained non-investigator person. The investigator and the participants were not aware of the allocation and will remain unaware till the end of the study. N/A Condition 1: Mental disorders. Condition 2: Mental disorders. Intervention 1: Intervention group: Mediterranean diet instructions. Participants will be asked to follow the instructions during the 12 weeks of interventions. The details of Mediterranean diet instructions are as follows: 1- Change your protein type. Use more vegetable proteins such as beans, peas and nuts. Eat fish at least 2-3 times a week. Use oily fish such as salmon. Try not to cook fish fried. Use white meats such as chicken and turkey every 2-3 days. Limit the consumption of red meat such as beef and veal to once a week. Avoid processed meats such as sausages. 2- Modify your cooking oils. Use olive oil. Remove hydrogenized oils. Reduce your butter consumption and replace it with healthy oils. If you do not have access to olive oil, use canola oil 3- Increase consumption of vegetables. Eat at least 3 glasses of different vegetables with different colors daily. 4- Eat more fruits. Eat at least two seasonal fruits daily. 5- If possible, consume 30 grams of raw nuts every other day, such as: pistachios, walnuts, almonds and Hazelnuts 6- Choose all your bread from whole grain breads. Whole grain breads are darker in color than non-whole grain breads. Limit rice consumption to twice a week. 7- Consume simple sugars such as sweets, cakes. Completely limit candy, desserts and soft drinks. Patients' follow-up status will be monitored by telephone during the intervention. Intervention 2: Control group: Usual healthy nutrition instructions. Participants in the intervention group will be asked to follow the instructions for 12 weeks. The healthy eating instructions for the control group are as follows: 1. Remove hydrogenized and saturated fats. Use liquid oils 2- Reduce the consumption of animal fats 3- Reduce your salt intake and eliminate table salt 4- Eat at least 2 glasses of milk daily 5- Try to have 3 times of physical activity during the week such as walking 6- Reduce the consumption of fatty foods 7- Avoid consuming large amounts of food per meal 8- Do not skip any meals 9- Eat breakfast always 10- Have 3 main meals and 3 snacks every day 11- Consume tea and coffee at least 2 hours after meals. Patients' follow-up status will be monitored by telephone during the intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Karim Parastouei
Mollasadra Ave., Vanak Sq.
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 4470 Parastouei@gmail.com Bagheiat-allah University of Medical Sciences scientific Karim Parastouei
Mollasadra street, Vanak Square, Baqiyatallah University of Medical Sciences
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8755 4470 parastouei@gmail.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Age between 20-59 years Suffering from depression, anxiety or stress disorders for more than one month 18 years 60 years Both If questionnaires were not completed properly If the instructions were not followed during intervention If dietary intake was miss reported (<800 or >4200 Kcal/day) Presence of stresses like divorce or emotional break up in the last 6 months Body mass index <18.5 or >40 History of death of relatives or close friends in the last 6 months Drug or alcohol abuse at least once a week Suffering from chronic diseases such as diabetes, cardiovascular, cancer, blood pressure Pregnancy and lactating F32 F41.1 Major depressive disorder, single episode Generalized anxiety disorder Lifestyle Placebo Intervention group: Mediterranean diet instructions. Participants will be asked to follow the instructions during the 12 weeks of interventions. The details of Mediterranean diet instructions are as follows: 1- Change your protein type. Use more vegetable proteins such as beans, peas and nuts. Eat fish at least 2-3 times a week. Use oily fish such as salmon. Try not to cook fish fried. Use white meats such as chicken and turkey every 2-3 days. Limit the consumption of red meat such as beef and veal to once a week. Avoid processed meats such as sausages. 2- Modify your cooking oils. Use olive oil. Remove hydrogenized oils. Reduce your butter consumption and replace it with healthy oils. If you do not have access to olive oil, use canola oil 3- Increase consumption of vegetables. Eat at least 3 glasses of different vegetables with different colors daily. 4- Eat more fruits. Eat at least two seasonal fruits daily. 5- If possible, consume 30 grams of raw nuts every other day, such as: pistachios, walnuts, almonds and Hazelnuts 6- Choose all your bread from whole grain breads. Whole grain breads are darker in color than non-whole grain breads. Limit rice consumption to twice a week. 7- Consume simple sugars such as sweets, cakes. Completely limit candy, desserts and soft drinks. Patients' follow-up status will be monitored by telephone during the intervention. Control group: Usual healthy nutrition instructions. Participants in the intervention group will be asked to follow the instructions for 12 weeks. The healthy eating instructions for the control group are as follows: 1. Remove hydrogenized and saturated fats. Use liquid oils 2- Reduce the consumption of animal fats 3- Reduce your salt intake and eliminate table salt 4- Eat at least 2 glasses of milk daily 5- Try to have 3 times of physical activity during the week such as walking 6- Reduce the consumption of fatty foods 7- Avoid consuming large amounts of food per meal 8- Do not skip any meals 9- Eat breakfast always 10- Have 3 main meals and 3 snacks every day 11- Consume tea and coffee at least 2 hours after meals. Patients' follow-up status will be monitored by telephone during the intervention. Weight. Timepoint: َََAt the beginning and end (12 weeks) of the study. Method of measurement: Scale, kg. Body Mass Index. Timepoint: َََAt the beginning and end (12 weeks) of the study. Method of measurement: Equation, Weight(kg)/[height(m)]2 , kg/m2. Score of stress. Timepoint: َََAt the beginning and end (12 weeks) of the study. Method of measurement: DASS-21 questionnaire. Anxiety score. Timepoint: َََAt the beginning and end (12 weeks) of the study. Method of measurement: DASS-21 questionnaire. Depression score. Timepoint: َََAt the beginning and end (12 weeks) of the study. Method of measurement: DASS-21 questionnaire. Healthy lifestyle score. Timepoint: At the end of the study. Method of measurement: HLS questionnaire. Food intake frequency. Timepoint: At the beginning and end (12 weeks) of the study. Method of measurement: Food Frequency questionnaire - 168 items. Physical activity. Timepoint: At the beginning and end (12 weeks) of the study. Method of measurement: IPAQ questionnaire. Bagheiat-allah University of Medical Sciences Approved 2020-09-20 Ethics Committee of Baqiyatallah University of Medical Sciences Molla Sadra Ave., Vannak Sq. Tehran Tehran Iran (Islamic Republic of)