]>
IRCT20191121045464N1 IRCT 2020-07-06 Tehran University of Medical Sciences Comparison of the effects of two weight loss diets (High fat diet and Standard diet) Comparison of high-fat and low-carbohydrate weight loss diet with standard weight loss diet on body composition, appetite and anthropometric measurements in overweight and obese children 2020-07-05 anticipated 94 Complete https://irct.ir/trial/43731 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individuals using the Permuted Block Randomization method will be divided into two groups. To create a random sequence in the block randomization approach, the website http://www.sealedenvelopepe.com will be used. The project methodologist is also given a random sequence to hide the allocation concealment. Then, the researcher communicates with the mentioned people based on the order of the participants entering the study and communicates with the said person about the random allocation of the participants to the study and asks about the random allocation of the participant to the specific group. For each intervention, a number (multi-digit code) is defined and entered on the envelope according to the random sequence created, Blinding description: The trial is planned in such a way that the evaluator of weight and body composition does not understand which of the two groups (High-fat weight loss diet and Standard weight loss diet) belong to the participant. 3 Overweight and obesity. Intervention 1: Intervention group: High fat and low carbohydrate (55% of total energy as fat, 20% of total energy as protein 25% of total energy as carbohydrate ) and the amount of diet energy is 500 kcal below the individual requirement .Everyone will also be given dietary advice.The duration of the diet will be 6 weeks. Intervention 2: Control group: Standard diet (55% of total energy as carbohydrate, 20% of total energy as protein 25% of total energy as fat ) and the amount of diet energy is 500 kcal below the individual requirement .Everyone will also be given dietary advice.The duration of the diet will be 6 weeks. 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 No more information
public Mohaddeseh Hasanzadeh
No.207 ,18/2 Ave. , Besat Blvd.
Shiraz Iran (Islamic Republic of) 7183613317 +98 71 3648 0127 hasanzade-m@razi.tums.ac.ir Tehran University of Medical Sciences scientific Mohaddeseh Hasanzadeh
No.207 ,18/2 Ave. , Besat Blvd.
Shiraz Iran (Islamic Republic of) 7183613317 +98 71 3648 0127 hasanzade-m@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) BMI(Body mass index) for age above 85th percentile Parents' consent to participate in the project 9 years 18 years Female BMI (body mass index) for age is normal Treatment - Other Treatment - Other Intervention group: High fat and low carbohydrate (55% of total energy as fat, 20% of total energy as protein 25% of total energy as carbohydrate ) and the amount of diet energy is 500 kcal below the individual requirement .Everyone will also be given dietary advice.The duration of the diet will be 6 weeks Control group: Standard diet (55% of total energy as carbohydrate, 20% of total energy as protein 25% of total energy as fat ) and the amount of diet energy is 500 kcal below the individual requirement .Everyone will also be given dietary advice.The duration of the diet will be 6 weeks Children's body mass index percentile. Timepoint: The first week and the sixth week. Method of measurement: Body weight in kilogram divided by the square of the height in meters. Individual weight with minimum clothing and no shoes with 0.1 kg accuracy. Timepoint: The first week and the sixth week. Method of measurement: Scale. Children's height in standing position without shoes with 0.5 accuracy. Timepoint: The first week and the sixth week. Method of measurement: Stadiometer. Waist circumference measurement in the midline between the lower rib and the upper part of the iliac bone. Timepoint: The first week and the sixth week. Method of measurement: Meter. Measuring the most articulated part of the hip. Timepoint: The first week and the sixth week. Method of measurement: Meter. Waist to hip ratio. Timepoint: The first week and the sixth week. Method of measurement: Waist circumference divided by hip circumference. Appetite score by ADAT questionnaire(The Appetite and Diet Assessment Tool). Timepoint: The first week and the sixth week. Method of measurement: ADAT questionnaire(The Appetite and Diet Assessment Tool). Fat mass measured by Bioelectrical Impedance Analysis (BIA)with minimal clothing and no shoes. Timepoint: The first week and the sixth week. Method of measurement: Bioelectrical Impedance Analysis. Lean body mass measured by Bioelectrical Impedance Analysis with minimal clothing and no shoes. Timepoint: The first week and the sixth week. Method of measurement: Bioelectrical Impedance Analysis (body weight - fat mass). Interstitial water measured by Bioelectrical Impedance Analysis with minimal clothing and no shoes. Timepoint: The first week and the sixth week. Method of measurement: Bioelectrical Impedance Analysis. Tehran University of Medical Sciences Approved 2019-12-12 Ethics committee of Tehran University of Medical Sciences Tehran University of Medical Sciences Central Building, Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)