Evaluating the Effects of Transcranial Direct Current Stimulation and Exercise Training on Food Craving and Impulsivity in Overweight and Obese Females

Effect of transcranial direct current stimulation and exercise training on food craving, impulsivity, risky decision making, depression, self-concept, and cognitive flexibility in overweight and obese females

The randomized trial, with the control group, parallel groups, double-blind on 36 patients. Randomization was performed using the randomization.com website.

This study is conducted at Razi University, Kermanshah, Iran. Study variables are measured before and after brain stimulation and exercise training for 4 weeks. Participants and investigators will be blinded about brain stimulation procedure.

Inclusion: 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 Getting the certification of no prohibition of participating in the exercise training program from a specialist Exclusion: En History of seizures, epilepsy, or other neurological diseases Existence of implantable devices or pacemakers in the body Tobacco, alcohol, and drug consumption Existence of musculoskeletal disorders Participation in regular exercise training program or weight loss program in the last 6 months Menopause

Group 1: 5 sessions of anodal brain stimulation in 5 consecutive days, followed by 4 weeks and 3 sessions of aerobic exercises every week with an intensity of 50 to 60% of the heart rate reserve. Group 2: 5 sessions of sham brain stimulation in 5 consecutive days followed by 4 weeks and 3 sessions of aerobic exercises every week with an intensity of 50 to 60% of the heart rate reserve. Group 3: did not receive any intervention and will have a normal routine of life during the research period.

Changes in food craving, impulsivity, risky decision-making, depression, self-concept, and cognitive flexibility

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.

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.

All data are shared after the de-identification of the participants

3 months after publication

All individuals upon formal request

Data sharing requests are accepted for any purposes

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

Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail