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IRCT20190831044657N1 IRCT 2023-06-12 Shiraz University of Medical Sciences diet combined with nutrition education on metabolic syndrome risk factors The effect of diet combined with nutrition education on metabolic syndrome risk factors, and dietary habits among over weight and obese employees working in Shiraz University of Medical Sciences 2023-07-23 anticipated 70 Complete https://irct.ir/trial/69871 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be done by random block method. In this method, qualified people who met the study entry criteria will be selected and then they will be randomly divided into two groups using blocks of 4. The randomization tool will be a random sequence generation software, which, in addition to simple randomization, is capable of generating a random sequence using the block method. The randomization unit is the individual. In fact, the number of modes that each block of 4 can be combined for two treatment groups includes 6 different modes (mode 1: AABB, mode 2: ABAB, mode 3: ABBA, mode 4: BAAB, mode 5: BBAA , Mode 6: BABA). Then, one of the blocks will be selected using the dice of any number obtained. The arrangement of people in each block is based on last name and in alphabetical order. In order to conceal, using opaque letter envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card, and the cards are placed inside the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of registration of the participants, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: All people will be coded, and in this case, the outcome assessor and data analyst will not be aware of the groups to which people are assigned and the type of intervention. 3 People with obesity and overweight. Intervention 1: Nutrition education along with diet. Intervention 2: Receive the diet. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public maryam Maharat
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3212 7873 maharatnut@gmail.com Shiraz University of Medical Sciences scientific Seyedeh Parisa Moosavian
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
shiraz Iran (Islamic Republic of) 71348-14336 +98 71 3212 2445 p_moosavian@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Participants having BMI more than 25 At least have one year work experience Having informed consent to enter the study 18 years no limit Both suffering from comorbidities such as diabetes, thyroid disorders,, liver or kidney diseases, and other chronic disorder being pregnant or lactating using weight lose diet Other Other Nutrition education along with diet Receive the diet Waist circumference. Timepoint: At the beginning of the study and 4 months later. Method of measurement: Waist circumference will be measured using a tape measure with an accuracy of 0.1 cm from the middle point between the last rib and the hip bone. Fasting blood sugar. Timepoint: At the beginning of the study and 4 months later. Method of measurement: At the beginning and end of the study, a blood sample of 5 cc will be taken from the subjects after 10-12 hours of fasting. Fasting blood sugar (FBS) will be measured by enzymatic methods and using special kits. TG. Timepoint: At the beginning of the study and 4 months later. Method of measurement: At the beginning and end of the study, a blood sample of 5 cc will be taken from the subjects after 10-12 hours of fasting. TG will be measured by enzymatic methods and using special kits. HDL. Timepoint: At the beginning of the study and 4 months later. Method of measurement: At the beginning and end of the study, a blood sample of 5 cc will be taken from the subjects after 10-12 hours of fasting. HDL will be measured by enzymatic methods and using special kits. Weight. Timepoint: At the beginning of the study and 4 months later. Method of measurement: At the beginning and at the end of the study, the height of the subjects will be measured with a seca height meter in a standing position without shoes with an accuracy of 0.1 cm and their weight will be measured with a seca scale with an accuracy of 100 grams in light clothes without shoes. Shiraz University of Medical Sciences Approved 2023-01-08 Ethics committee of Shiraz University of Medical Sciences Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)