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IRCT20200927048848N1 IRCT 2020-09-30 Mashhad University of Medical Sciences Effect of Cryolipolysis and Diet on Metabolic Factors and Fat Layer Thickness Effect of Cryolipolysis and Diet on Metabolic Factors and Fat Layer Thickness 2020-09-22 anticipated 50 Complete https://irct.ir/trial/51239 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done in a simple way. Random numbers will be obtained individually using the Randomaization.com random number table. A sealed envelope will be used to conceal the allocation of participants. For this purpose, one of the members of the research team prepares and prints the obtained random numbers and puts them in the envelope. The lids of the envelopes will be sealed and its contents will not be visible from the outside. First, the purpose of the study is explained to the person who meets the conditions, and the person, if desired, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope. , Blinding description: Findings obtained from the study will be entered and coded in SPSS software. In the file that will be provided to the analyst for statistical analysis, the different modes of all qualitative variables, including the type of group (control intervention) will be coded with numbers, so the type of group studied will be unknown to the analyst. 3 overweight (BMI between 25 and 29.9). Intervention 1: In the cryolipolysis intervention group, the first week and the fourth week are performed in 2 sessions, each session will include 60 minutes in each position. In this study, Fusiomed model cryolipolysis machine with BIO TEC brand made in Italy is used. After cryolipolysis, massage will be performed on the cryo site for two minutes. Diet assessment and visit to a nutritionist will be done 3 times, at the beginning of the study, week 4 and the end of the study (week 8). Intervention 2: In the control group, diet assessment and visit to a nutritionist will be done 3 times, at the beginning of the study, week 4 and at the end of the study (week 8). 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 data available.
public Mahmood Ebrahimi
cardiovascular departement, Imam Reza hospital
Mashhad Iran (Islamic Republic of) 913791331 0098 51 3854450 EbrahimiMH@mums.ac.ir Mashhad University of Medical Sciences scientific Mahmood Ebrahimi
Cardiovascular departement, Imam Reza hospital
Mashhad Iran (Islamic Republic of) 913791331 0098 51 3854450 EbrahimiMH@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 18-25 Informed consent Body mass index (BMI) between 25-29.9 18 years 65 years Female underlying disease E66.3 Overweight Treatment - Devices Lifestyle In the cryolipolysis intervention group, the first week and the fourth week are performed in 2 sessions, each session will include 60 minutes in each position. In this study, Fusiomed model cryolipolysis machine with BIO TEC brand made in Italy is used. After cryolipolysis, massage will be performed on the cryo site for two minutes. Diet assessment and visit to a nutritionist will be done 3 times, at the beginning of the study, week 4 and the end of the study (week 8). In the control group, diet assessment and visit to a nutritionist will be done 3 times, at the beginning of the study, week 4 and at the end of the study (week 8). Anthropometric measurements. Timepoint: At the beginning of the study, week 4, at the end of the study (week 8). Method of measurement: Body composition analyzer of BIA770 made in South Korea. Serum lipid profile including TG, HDL-C, LDL-C, total cholesterol, bloods glucose and hs-CRP. Timepoint: At the beginning of the study and at the end of the study (week 8). Method of measurement: BT-3000 auto analyzer. Fat layer thickness. Timepoint: At the beginning of the study and at the end of the study (week 8). Method of measurement: ultrasound. Body satisfaction. Timepoint: At the beginning of the study and at the end of the study (week 8). Method of measurement: body satisfaction questionnaire (Kessler). Mashhad University of Medical Sciences Approved 2020-07-18 Ethics committe of Mashhad University of Medical Sciences Gharshi building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)