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
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Sharing plan
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yes
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اطلاعات بیشتری وجود ندارد
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اطلاعات بیشتری وجود ندارد
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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.
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.
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عنوان داده ها اثررژیم فستینگ متناوب اصلاح شده بر کیفیت خواب و شاخصهای آنتروپومتری خواهد بود. کل داده ها پس از غیرقابل شناسایی کردن افراد قابل اشتراک گذاری است.
عنوان داده ها اثررژیم فستینگ متناوب اصلاح شده بر کیفیت خواب و شاخصهای آنتروپومتری خواهد بود. کل داده ها پس از غیرقابل شناسایی کردن افراد قابل اشتراک گذاری است.
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Six months after publishing results, everything will be accessible.
Six months after publishing results, everything will be accessible.
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شروع دوره دسترسی 6 ماه پس از چاپ نتایج خواهد بود.
شروع دوره دسترسی 6 ماه پس از چاپ نتایج خواهد بود.
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The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions
The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions
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داده های این پژوهش صرفاً در اختیار محققین حوزه سلامت و شاغل در مؤسسات دانشگاهی و علمی قرار خواهد گرفت.
داده های این پژوهش صرفاً در اختیار محققین حوزه سلامت و شاغل در مؤسسات دانشگاهی و علمی قرار خواهد گرفت.
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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.
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.
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از داده های این پژوهش با رعایت ملاحظات اخلاقی می توان در سایر اهداف پژوهشی استفاده کرد. انجام هرگونه تجزیه و تحلیل آماری بلامانع است. انجام تمام این فرایندها مستلزم مکاتبه و هماهنگی است.
از داده های این پژوهش با رعایت ملاحظات اخلاقی می توان در سایر اهداف پژوهشی استفاده کرد. انجام هرگونه تجزیه و تحلیل آماری بلامانع است. انجام تمام این فرایندها مستلزم مکاتبه و هماهنگی است.
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All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
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تمام متقاضیان می توانندبا آقای دکتر جعفرنژاد از طریق پست الکترونیکیdrsadegh2008@gmail.com تماس حاصل نمایند.
تمام متقاضیان می توانندبا آقای دکتر جعفرنژاد از طریق پست الکترونیکیdrsadegh2008@gmail.com تماس حاصل نمایند.
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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.
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.
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پس از مکاتبه یا تماس، به فاصله 10 روز کاری به درخواست شما پاسخ داده خواهد شد و داده ها به یک ایمیل معتبر که از سوی متقاضی معرفی می شود، ارسال می گردد.
پس از مکاتبه یا تماس، به فاصله 10 روز کاری به درخواست شما پاسخ داده خواهد شد و داده ها به یک ایمیل معتبر که از سوی متقاضی معرفی می شود، ارسال می گردد.
Protocol summary
Study aim
omparison of the effect of modified intermittent fasting diet and daily calorie restriction diet on sleep quality and anthropometric indices of obese or overweight adult women 18 to 50 years
Design
This is a randomized, controlled, parallel-group trial. Participants will be stratified using stratified randomization based on age and BMI. Then using the random numbers table are assigned to one of the two groups intervention and control. Because it is a diet intervention, it is not blinding. The trial phase is not applicable.
Settings and conduct
Participants are selected from the Health Centers of Kashan University of Medical Sciences by convenient sampling. Participants are randomly assigned into two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women in the age range of 18 to 50 years and body mass index greater than or equal to 25 and less than 40.
Exclusion criteria: pregnancy, lactation, chronic diseases such as hypertension, heart disease, diabetes, gastrointestinal disorders such as gastritis, gastric and duodenal ulcers, Smoking habits, alcoholism, weight loss of 1 to 2 kg in the past month, following a special diet or taking certain medications, taking dietary supplements, having a mental disorder
Intervention groups
Intervention: The energy requirements for the individuals calculate using the Mifflin equation. It involves alternating periods of feeding and fasting, on an every-other-day basis. Fasting day only comprises 25% of the recommended calorie intake. On feeding days, the participants are provided foods at 100% of calculated daily energy requirements.
control: The energy requirements for the individuals calculate using the Mifflin equation. subjects consume 63% of their energy requirement each day.
Main outcome variables
The sleep quality؛ daytime sleepiness؛ insomnia؛ BMI؛ FFM؛ and the body fat mass
General information
Reason for update
Due to the delay in the recruitment dates, we request to change the expected recruitment start date.
Acronym
IRCT registration information
IRCT registration number:IRCT20220522054958N3
Registration date:2022-07-08, 1401/04/17
Registration timing:prospective
Last update:2023-02-16, 1401/11/27
Update count:4
Registration date
2022-07-08, 1401/04/17
Registrant information
Name
Saeedeh Hosseini hooshiar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 9024
Email address
shoseinih3322@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-01, 1401/06/10
Expected recruitment end date
2022-12-30, 1401/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of Modified Intermittent Fasting Diet on sleep quality and anthropometric indices of obese and/or overweight adult women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
women in the age range of 18 to 50 years
BMI more than or equal to 25 and less than 40
Exclusion criteria:
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
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine and Dentistry - Kashan University of Medical Sciences (Research Ethics Committee
Street address
5 km Qutb Ravandi Boulevard, Kashan University of Medical Sciences, Vice Chancellor for Research
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2022-04-17, 1401/01/28
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1401.002
Health conditions studied
1
Description of health condition studied
overweight
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Obesity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Sleep Quality questionnaire
2
Description
daytime sleepiness
Timepoint
The beginning and end of the study
Method of measurement
Epworth Sleepiness questionnaire
3
Description
Insomnia
Timepoint
The beginning and end of the study
Method of measurement
Insomnia Severity questionnaire
4
Description
BMI
Timepoint
The beginning and end of the study
Method of measurement
Height: stadiometer, Weight: scale
5
Description
Free fat mass FM and the body fat mass
Timepoint
The beginning and end of the study
Method of measurement
Inbody Device
6
Description
The body fat mass
Timepoint
The beginning and end of the study
Method of measurement
Inbody Device
7
Description
waist circumference
Timepoint
The beginning and end of the study
Method of measurement
non-stretchable measuring tape
8
Description
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
9
Description
weight
Timepoint
The beginning and end of the study
Method of measurement
scales
Secondary outcomes
1
Description
The hip circumference
Timepoint
The beginning and end of the study
Method of measurement
non-stretchable measuring tape
2
Description
visceral fat area
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
3
Description
The percent body fat
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
4
Description
The soft lean mass
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
5
Description
The skeletal muscle mass
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
6
Description
the extracellular water ratio
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
7
Description
The total body water
Timepoint
The beginning and end of the study
Method of measurement
Inbody device
8
Description
Subjective sleep quality (SSQ)
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Sleep Quality Index (PSQI) questionnaire
9
Description
Sleep latency
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Sleep Quality Index (PSQI) questionnaire
10
Description
Sleep duration
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Sleep Quality Index (PSQI) questionnaire
11
Description
Habitual sleep efficiency
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Sleep Quality Index (PSQI) questionnaire
12
Description
Sleep disturbances
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Sleep Quality Index (PSQI) questionnaire
13
Description
use of sleeping medication
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Sleep Quality Index (PSQI) questionnaire
14
Description
daytime dysfunction
Timepoint
The beginning and end of the study
Method of measurement
Pittsburgh Sleep Quality Index (PSQI) questionnaire
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Saeede Hoseini
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
5th of Qotb –e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Fax
+98 31 5554 1112
Email
shoseinih3322@gmail.com
Web page address
http://en.kaums.ac.ir/Default.aspx?PageID=199
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Saeede Hoseini
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
5th of Qotb –e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 1112
Fax
+98 31 5554 1112
Email
shoseinih3322@gmail.com
Web page address
http://en.kaums.ac.ir/Default.aspx?PageID=199
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Saeedeh Hosseini hooshiar
Position
Ms
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Kashan university of medical science
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5558 9024
Fax
Email
shoseinih3322@gmail.com
Web page address
http://en.kaums.ac.ir/Default.aspx?PageID=199
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
Six months after publishing results, everything will be accessible.
To whom data/document is available
The data from this research will be accessible only to health researchers and those who are working in academic and scientific institutions
Under which criteria data/document could be used
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.
From where data/document is obtainable
All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
What processes are involved for a request to access data/document
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.