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IRCT20210617051606N7 IRCT 2023-02-04 Razi University Effect of aerobic exercise and brain stimulation on food craving Evaluating the Effects of Transcranial Direct Current Stimulation and Exercise Training on Food Craving and Impulsivity in Overweight and Obese Females 2023-02-09 anticipated 36 Complete https://irct.ir/trial/68396 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, permuted block randomization via the www.randomization.com website will be used. To do so, first, a unique number will be allocated to each subject as the identifier code and, a 36-digit sequence (equal to the sample size) will be created. Then, treatment labels including 1) Exercise + anodal stimulation group; 2) Exercise + sham stimulation group; and 3) Control group will be entered in the relevant section on the website. After defining the treatment groups and avoiding potential problems associated with equal block sizes, permuted block randomization with different block sizes will be applied. In this case, by knowing the sample size, the block sizes will be unequal and a multiple of the number of treatment groups (for example, block sizes of 2, 4, or 6). The website has the ability to specify the sequence of blocks with different sizes randomly. In the final step and upon performing the 'Generate Plan' on the website, all subjects will be randomly assigned to blocks of different sizes that already have a random sequence. Finally, the group (treatment) of each subject will be specified by the use of the identifier code and by checking out the blocks, Blinding description: In this double-blind study, the investigator and the participants will be blinded to the type of transcranial electrical stimulation used in the two experimental groups. In the current study, the Neurostim stimulation device will be used to induce direct current electrical stimulation in two conditions including 1) anodal and 2) sham in two experimental groups. For this purpose, an individual outside the research team and fully familiar with how to use the brain stimulation device will be responsible for applying the stimulation for 5 consecutive days. In order to blind the participants, after they sit on a special chair, the stimulating device is hidden from their view and is completely covered by a cover, and the electrodes are placed on the desired areas by the examiner. In order to blind the researcher, the induction of brain stimulation will be done without the presence of the researcher and the relevant information will be available to the same person outside the research team. Also, in the sham stimulation mode, according to standard protocols, the active current is induced on the head for 30 seconds to induce the same sensation as the active stimulation mode, and then the current is cut off and the stimulation is deactivated, but the electrodes are used until the end of the same time as the stimulation. Anodal will remain on the head. N/A Overweight and obesity. Intervention 1: Intervention group 1: this group will receive 5 sessions of anodal stimulation over the dorsolateral prefrontal cortex in 5 consecutive days, and then perform 3 exercise sessions every week for 4 weeks with an intensity of 50 to 60% of the heart rate reserve. The duration of each training session will be 20 minutes in the first week, 25 minutes in the second week, 30 minutes in the third week, and 35 minutes in the fourth week. Intervention 2: Intervention group 2: this group will receive 5 sessions of sham stimulation over the dorsolateral prefrontal cortex in 5 consecutive days, and then perform 3 exercise sessions every week for 4 weeks with an intensity of 50 to 60% of the heart rate reserve. The duration of each training session will be 20 minutes in the first week, 25 minutes in the second week, 30 minutes in the third week, and 35 minutes in the fourth week. Intervention 3: Control group: This group did not receive any intervention during the research period and will have a normal routine of life. Yes - There is a plan to make this available What will be shared: All data are shared after the de-identification of the participants When: 3 months after publication To whom: All individuals upon formal request Conditions: Data sharing requests are accepted for any purposes Where to obtain: To obtain any data/document, please send an e-mail to Ehsan Amiri, a faculty member at Razi University, through the following e-mail address: e.amiri@razi.ac.ir How to obtain: Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail Comments:
public Ehsan Amiri
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 e.amiri@razi.ac.ir Razi University scientific Ehsan Amiri
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 e.amiri@razi.ac.ir Razi University Iran (Islamic Republic of) Aged between 18 to 50 years Resident of Kermanshah Body mass index between 25 to 34.9 kg/m2 Being right handed Having food cravings (total score of 108 or above according to the 15-item food craving questionnaire and 12-point visual analog food craving questionnaire) Getting the certification of no prohibition of participating in the exercise training program from a specialist 18 years 50 years Female History of seizures, epilepsy, or other neurological diseases Existence of implantable devices or pacemakers in the body Tobacco, alcohol, and drug consumption Existence of ant musculoskeletal disorders Participation in regular exercise training program or weight loss program in last 6 months Menopause E66 Overweight and obesity Lifestyle Lifestyle N/A Intervention group 1: this group will receive 5 sessions of anodal stimulation over the dorsolateral prefrontal cortex in 5 consecutive days, and then perform 3 exercise sessions every week for 4 weeks with an intensity of 50 to 60% of the heart rate reserve. The duration of each training session will be 20 minutes in the first week, 25 minutes in the second week, 30 minutes in the third week, and 35 minutes in the fourth week. Intervention group 2: this group will receive 5 sessions of sham stimulation over the dorsolateral prefrontal cortex in 5 consecutive days, and then perform 3 exercise sessions every week for 4 weeks with an intensity of 50 to 60% of the heart rate reserve. The duration of each training session will be 20 minutes in the first week, 25 minutes in the second week, 30 minutes in the third week, and 35 minutes in the fourth week. Control group: This group did not receive any intervention during the research period and will have a normal routine of life. Change in food craving. Timepoint: Before and after interventions. Method of measurement: Standard questionnaires of food craving. Impulsivity. Timepoint: Before and after interventions. Method of measurement: Go/ No Go cognitive test software. Risky decision-making. Timepoint: Before and after interventions. Method of measurement: IOWA gambling cognitive test software. Depression. Timepoint: Before and after interventions. Method of measurement: Center for epidemiologic studies depression scale. Self-concept. Timepoint: Before and after interventions. Method of measurement: Robson self-concept questionnaire. Cognitive flexibility. Timepoint: Before and after interventions. Method of measurement: cognitive flexibility questionnaire. Razi University Approved 2022-04-20 Research Ethics Committees of Kermanshah Razi University Room. 73, Faculty of Sport Sciences, Razi University, University Str, Taq-e-bostan, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)