Evaluating the effectiveness of transcranial direct current stimulation(tDCS) and oxytocin on cognitive, emotion and weight control in food addicts: A double-blind Randomized clinical trial.

Determining the effectiveness of cranial direct current stimulation and oxytocin on cognitive, emotional and weight control performance in obese food addicts.

Clinical trial whitout group of control , parallel-group, double-blind, randomized, phase 2 in 45 patients will be conducted using Stata 9.0 statistical software.

The place of evaluation and interventions will be Shahid Beheshti Hospital, Zanjan. During the intervention, in order to maintain the concealment mechanism, sequentially numbered and prepackaged containers that have the same appearance will be used. The interventionist and the researcher do not know about the contents of the envelope and the type of group.

Inclusion criteria: Male or female participants aged between 20 and 65 years and BMI>30 and are known ‘food addiction” based on the questionnaire (YFAS). Not having diabetes, malignancy, heart disease, uncontrolled blood pressure, psychiatric disease. Exclusion criteria: Sensitivity to oxytocin, lack of cooperation, occurrence of emergency factors, if pregnant or pregnant during the study

The study of all men and women in Zanjan city, who are between 20 and 65 years old and have a BMI>30 and will be diagnosed food addiction based on the questionnaire (YFAS). First, the first group will receive tDCS and at the same time they will receive oxytocin in the form of placebo (sodium chloride). The second group will receive oxytocin and receive sham tDCS at the same time. Finally, the third group will receive (OXT-tDCS) intervention.

Cognitive performance variable by go/no test and dotprob, emotion variable by Gross and John emotion regulation questionnaire, weight control by BMI table and scale, food addiction by Yale questionnaire and craving by food craving questionnaire - attribute will be measured

All the participants were completely randomized in a 6-block classification type (due to the allocation of at least three groups and the parallelism of the design and to control the gender variable), the randomization sequence was created using Stata 9.0 statistical software (StataCorp, College Station, TX). and will be classified using block sizes of 6 with 1:1 allocation and three groups will be formed. Then the treatment plan will be implemented. During the intervention, in order to maintain the allocation concealment mechanism, containers with consecutive numbering will be pre-packed and will have the same appearance. And waxed and stapled will be hidden. Aluminum foil is used inside the envelope so that the envelope is impervious to strong light. In order to prevent confusion in the order of allocation, the participant's name and date of birth are written on the envelope and a video tape is recorded of the sealed envelope with the participant's information. Block randomization will be performed by a list of computer-generated random numbers prepared by an investigator with no clinical involvement in the trial.

Blinding of researcher and participant: The drugs are presented to the participants in a completely similar container and coded by the design partners, the participants and the partner who applies the drug have no knowledge about the contents of the drug, the intervening partner in the application of TDCS at the defined hours. will apply the intervention method and has no knowledge about the division of the group.