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IRCT20220522054958N3 IRCT 2022-07-08 Kashan University of Medical Sciences The effect of Modified Intermittent Fasting Diet on sleep quality and anthropometric indices of obese and/or overweight adult women Comparison of the effect of Modified Intermittent Fasting Diet and Daily Calorie Restriction Diet on sleep quality and anthropometric indices of obese and/or overweight adult women 18 to 50 years 2022-09-01 anticipated 56 Complete https://irct.ir/trial/64510 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Subjects are selected by a convenient sampling method. Then, participants are divided into groups of control and intervention by simple randomization and using the random numbers table. The randomization method is that at the beginning, it is agreed to give the intervention group the odd number and the control group the even number. Therefore, participants are assigned to the control or intervention group depending on whether we reach the odd or even number in the random numbers table. Randomization is individual. N/A Condition 1: overweight. Condition 2: Obesity. Intervention 1: Intervention group: The energy requirements for the individuals calculate using the Mifflin equation. Then, alternately, one day 25% of the energy and the next day 100% of the required energy is provided. On fasting days, one can get 25% of the daily calories needed from 12 noon to 2 pm. This diet is followed for 8 weeks. Intervention 2: Control group: The energy requirements for the individuals calculate using the Mifflin equation. subjects consume 63% of their energy requirement each day. This diet is followed for 8 weeks. Yes - There is a plan to make this available What will be shared: The title of the data will be ‘’the effect of Modified intermittent Fasting Diet on sleep quality and anthropometric indices ’’. All data can be shared after making participants anonymous. When: Six months after publishing results, everything will be accessible. To whom: The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions Conditions: With respect to ethical considerations, the data from this research can be used for other research purposes. It is also possible to conduct any statistical analyses. All these processes require correspondence and coordination. Where to obtain: All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com How to obtain: Within 10 working days after correspondence or a phone call, your request will be answered and the data will be sent to a valid email submitted by the applicant. Comments:
public Saeede Hoseini
5th of Qotb –e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 1112 shoseinih3322@gmail.com Kashan University of Medical Sciences scientific Saeede Hoseini
5th of Qotb –e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 1112 shoseinih3322@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) women in the age range of 18 to 50 years BMI more than or equal to 25 and less than 40 18 years 50 years Female pregnancy breastfeeding Chronic diseases such as high blood pressure, heart disease, diabetes, gastrointestinal disorders such as gastritis, peptic ulcer and duodenal ulcer the habit of smoking alcohol abuse weight loss of 1 to 2 kg in the past month following a specific diet or taking a specific medication taking dietary supplements Having mental disorders Having overnight shifts Prevention Prevention Intervention group: The energy requirements for the individuals calculate using the Mifflin equation. Then, alternately, one day 25% of the energy and the next day 100% of the required energy is provided. On fasting days, one can get 25% of the daily calories needed from 12 noon to 2 pm. This diet is followed for 8 weeks. Control group: The energy requirements for the individuals calculate using the Mifflin equation. subjects consume 63% of their energy requirement each day. This diet is followed for 8 weeks. Sleep quality. Timepoint: The beginning and end of the study. Method of measurement: Pittsburgh Sleep Quality questionnaire. Daytime sleepiness. Timepoint: The beginning and end of the study. Method of measurement: Epworth Sleepiness questionnaire. Insomnia. Timepoint: The beginning and end of the study. Method of measurement: Insomnia Severity questionnaire. BMI. Timepoint: The beginning and end of the study. Method of measurement: Height: stadiometer, Weight: scale. Free fat mass FM and the body fat mass. Timepoint: The beginning and end of the study. Method of measurement: Inbody Device. The body fat mass. Timepoint: The beginning and end of the study. Method of measurement: Inbody Device. Waist circumference. Timepoint: The beginning and end of the study. Method of measurement: non-stretchable measuring tape. The waist-to-hip ratio. Timepoint: The beginning and end of the study. Method of measurement: by dividing the waist circumference by the hip circumference. Weight. Timepoint: The beginning and end of the study. Method of measurement: scales. The hip circumference. Timepoint: The beginning and end of the study. Method of measurement: non-stretchable measuring tape. Visceral fat area. Timepoint: The beginning and end of the study. Method of measurement: Inbody device. The percent body fat. Timepoint: The beginning and end of the study. Method of measurement: Inbody device. The soft lean mass. Timepoint: The beginning and end of the study. Method of measurement: Inbody device. The skeletal muscle mass. Timepoint: The beginning and end of the study. Method of measurement: Inbody device. The extracellular water ratio. Timepoint: The beginning and end of the study. Method of measurement: Inbody device. The total body water. Timepoint: The beginning and end of the study. Method of measurement: Inbody device. Subjective sleep quality (SSQ). Timepoint: The beginning and end of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. Sleep latency. Timepoint: The beginning and end of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. Sleep duration. Timepoint: The beginning and end of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. Habitual sleep efficiency. Timepoint: The beginning and end of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. Sleep disturbances. Timepoint: The beginning and end of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. Use of sleeping medication. Timepoint: The beginning and end of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. Daytime dysfunction. Timepoint: The beginning and end of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionnaire. Kashan University of Medical Sciences Approved 2022-04-17 Faculty of Medicine and Dentistry - Kashan University of Medical Sciences (Research Ethics Committee 5 km Qutb Ravandi Boulevard, Kashan University of Medical Sciences, Vice Chancellor for Research Kashan Isfehan Iran (Islamic Republic of)