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IRCT20140804018677N26 IRCT 2023-06-18 Shahid Beheshti University of Medical Sciences The effect of DASH diet in comparison with low calorie diet on food addiction and weight management in individuals with food addiction and weight regain 2 years after bariatric gastric surgery The effect of low calorie DASH diet in comparison with low calorie diet on food addiction and weight management in individuals with food addiction and weight regain 2 years after bariatric gastric surgery 2023-06-10 anticipated 98 Complete https://irct.ir/trial/70241 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants in the study are selected by convenience sampling method. Patients are classified according to age and gender, and each person will be placed in a group receiving group of dash diet or low-calorie diet using 1:1, quadruple random blocks. Quadruple blocks are randomly designed through software such as ...... (ABAB), (BBAB), (AABB), (ABBA), (BAAB). Assigning A or B to the group of dash diet or low-calorie diet will be done by someone outside the research so that the researchers remain blind. According to the list of randomly prepared quadruple blocks, a trained person outside the research team is responsible for randomly assigning patients. After each patient enters, according to the quadruple blocks prepared in the first stage, each patient is randomly assigned to group A or B. Assignment process will be done consecutively until the sampling is completed, Blinding description: This study will be a double-blind clinical trial, and therefore the participants, researchers, and the data analyst will be unaware that each person in the group receiving a high-calorie diet or a low-calorie diet will receive it. Blinding will be done by a third person outside the study. Therefore, the research team will not know the details of the groups until the end of data collection and data analysis. 3 Overweight and Obesity. Intervention 1: Intervention group: The intervention period in this clinical trial will be 16 weeks. Intervention group 1: People receive DASH-low calorie diet. Considering that people have undergone surgery and the calories required in the second year of surgery are calculated to be 1000-1200 calories. According to the same guidelines, the amount of protein intake will be 60 to 100 grams of protein per day or equivalent to 1.1 to 2.1 grams per kilogram of body weight based on the level of activity of the person. 35 to 48 percent of the required energy will come from carbohydrates and the rest of the energy will come from fat. It was more than 30%. In the group receiving the DASH diet, the diet will be adjusted according to the DASH pattern. Patients are visited once every 2 weeks during the study period. At the beginning of the study, at the end of the 16th week, the level of anxiety and depression in the people participating in the study was used with validated questionnaires. Then other evaluations such as physical activity, body composition measurements, food intake status, and serum levels of blood sugar and insulin were collected for the participants in the study. The level of physical activity and food addiction will be evaluated using the Yale questionnaire. Intervention 2: Intervention group 2: People on a low-calorie diet receive 1000-1200 calories per day. At the beginning of the study, at the end of the 16th week, the level of anxiety and depression in the people participating in the study was used with validated questionnaires. Then other evaluations such as physical activity, body composition measurements, food intake status, and serum levels of blood sugar and insulin were collected for the participants in the study. The level of physical activity and food addiction will be evaluated using the Yale questionnaire. Yes - There is a plan to make this available What will be shared: Coded data of the participants, study protocol, and report of the main output of the study would be available in case of researchers' reasonable request sending to principal investigator of the study 6 months after publishing the article. When: starting 6 months after publication To whom: University researchers Conditions: Have no condition Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: sending email Comments:
public Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 191574323 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razghei Jahromi
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
Tehran Iran (Islamic Republic of) 191574323 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study At least 2 years have passed since surgery Weight gain again after surgery No or very mild food addiction before sleeve surgery Suffering from food addiction based on the Yale questionnaire 18 years 65 years Both Any acute illness Suffering from chronic diseases such as diabetes, cardiovascular disease Taking drugs that affect appetite and weight pregnancy E66.01 Morbid (severe) obesity due to excess calories Lifestyle Lifestyle Intervention group: The intervention period in this clinical trial will be 16 weeks. Intervention group 1: People receive DASH-low calorie diet. Considering that people have undergone surgery and the calories required in the second year of surgery are calculated to be 1000-1200 calories. According to the same guidelines, the amount of protein intake will be 60 to 100 grams of protein per day or equivalent to 1.1 to 2.1 grams per kilogram of body weight based on the level of activity of the person. 35 to 48 percent of the required energy will come from carbohydrates and the rest of the energy will come from fat. It was more than 30%. In the group receiving the DASH diet, the diet will be adjusted according to the DASH pattern. Patients are visited once every 2 weeks during the study period. At the beginning of the study, at the end of the 16th week, the level of anxiety and depression in the people participating in the study was used with validated questionnaires. Then other evaluations such as physical activity, body composition measurements, food intake status, and serum levels of blood sugar and insulin were collected for the participants in the study. The level of physical activity and food addiction will be evaluated using the Yale questionnaire. Intervention group 2: People on a low-calorie diet receive 1000-1200 calories per day. At the beginning of the study, at the end of the 16th week, the level of anxiety and depression in the people participating in the study was used with validated questionnaires. Then other evaluations such as physical activity, body composition measurements, food intake status, and serum levels of blood sugar and insulin were collected for the participants in the study. The level of physical activity and food addiction will be evaluated using the Yale questionnaire. Weight. Timepoint: at the beginning of the study and 16 weeks later at the end of the study. Method of measurement: Scale. Food addiction. Timepoint: at the beginning of the study and 16 weeks later at the end of the study. Method of measurement: Food addiction questionnaire is not officially defined in DSM-5. But evidence has shown that there is considerable overlap between the characteristics of food addiction and the DSM-5 criteria for drug addiction. Therefore, the YFAS food addiction scale questionnaire, which is based on DSM-5 criteria, is widely used to diagnose food addiction. In the present study, food addiction was diagnosed by the YFAS questionnaire. The YFAS is a 25-item questionnaire, which examines eating behaviors based on seven diagnostic criteria for drug addiction (by DSM-5). People are diagnosed with food addiction if they have three or more of the seven criteria in the past year, along with the presence of a clinical disorder in the past 12 months. The total scores of this questionnaire are calculated from 0 to 7. Shahid Beheshti University of Medical Sciences Approved 2023-01-22 Research Ethics committees of National Nutrition & Food Technology Research Institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)