History
# Registration date Revision Id
5 2025-02-26, 1403/12/08 333924
4 2024-02-22, 1402/12/03 295864
3 2024-01-26, 1402/11/06 293258
2 2023-09-26, 1402/07/04 280156
1 2022-05-30, 1401/03/09 228087
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  • Protocol summary

    تعیین اثر رژیم روزه داری (فستینگ) متناوب اصلاح شده بر شاخص های اشتها، ولع به غذا و رفتارخوردن زنان بزرگسال چاق و یا دارای اضافه وزن 18 تا 50 سال
    تعیین اثر رژیم فستینگ متناوب اصلاح شده بر شاخص های اشتها، ولع به غذا و رفتارخوردن زنان بزرگسال چاق و یا دارای اضافه وزن 18 تا 50 سال
    A randomized, controlled clinical trial has been designed with two parallel groups of 56 patients. Individuals are selected by convenient sampling. Then, they are assigned to control (daily calorie restriction diet) and intervention (fasting diet) groups by simple randomization method and using a table of random numbers. Because there is diet intervention, blinding and the trial phase are not applicable.
    A randomized, controlled clinical trial has been designed with two parallel groups of 54 patients. Individuals will be recruited utilizing a simple random sampling technique. Then, they are assigned to control (daily calorie restriction diet) and intervention (fasting diet) groups by simple randomization method and using a table of random numbers. Because there is diet intervention, blinding and the trial phase are not applicable.
    یک کارآزمایی بالینی تصادفی و کنترل شده با دو گروه موازی 56 بیمار طراحی شده است. افراد به صورت نمونه گیری در دسترس انتخاب می شوند. سپس با روش تصادفي ساده و به وسیله جدول اعداد تصادفی به دو گروه کنترل (رژیم کاهش کالری روزانه) و مداخله (رژیم فستینگ) اختصاص داده می شوند. چون مداخله رژیم هست، کورسازی و فاز کارآزمایی کاربرد ندارد.
    یک کارآزمایی بالینی تصادفی و کنترل شده با دو گروه موازی 54 بیمار طراحی شده است. افراد با استفاده از روش نمونه گیری تصادفی ساده به کار گرفته می شوند. سپس با روش تصادفي ساده و به وسیله جدول اعداد تصادفی به دو گروه کنترل (رژیم کاهش کالری روزانه) و مداخله (رژیم فستینگ) اختصاص داده می شوند. چون مداخله رژیم هست، کورسازی و فاز کارآزمایی کاربرد ندارد.
    56 obese or overweight women will be selected by convenient sampling based on the inclusion and exclusion criteria of the study from Kashan health centers. Individuals are randomly assigned to one of the two groups of control and intervention.
    54 obese or overweight women will be selected by a simple random sampling technique based on the inclusion and exclusion criteria of the study from Kashan health centers. Individuals are randomly assigned to one of the two groups of control and intervention.
    تعداد 56 نفر خانم چاق و یا دارای اضافه وزن بر اساس معیارهای ورود و خروج مطالعه از مراکز بهداشت کاشان، به وسیله نمونه گیری آسان انتخاب خواهند شد. افراد به صورت کاملا تصادفي در يكي از دو گروه کنترل و مداخله قرار داده می شوند.
    تعداد 54 نفر خانم چاق و یا دارای اضافه وزن بر اساس معیارهای ورود و خروج مطالعه از مراکز بهداشت کاشان، به وسیله روش نمونه گیری تصادفی ساده انتخاب خواهند شد. افراد به صورت کاملا تصادفي در يكي از دو گروه کنترل و مداخله قرار داده می شوند.
    Inclusion criteria: Women in the age range of 18 to 50 years and their body mass index is more than or equal to 25 and less than 40 exclusion criteria: Pregnancy, Breastfeeding, chronic diseases such as high blood pressure, heart disease, diabetes, and gastrointestinal disorders , 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.
    Inclusion criteria: Women in the age range of 18 to 50 years and their body mass index is more than or equal to 25 and less than 40 exclusion criteria: Pregnancy, Breastfeeding, chronic diseases such as high blood pressure, heart disease, diabetes, and gastrointestinal disorders , the habit of smoking, alcohol abuse, recent weight loss of at least 1 kg within the past three months, following a specific diet or taking a specific medication, taking dietary supplements.
    معیارهای ورود: خانمها در محدوده سنی18 تا 50 سال و نمایه توده بدنی آنها بیشتر یا مساوی 25 و کمتر از 40 معیارهای خروج:بارداری، شیردهی، ابتلا به بیماری های مزمن مثل فشار خون، بیماری های قلبی، دیابت و بیماریهای گوارشی، عادت به کشیدن سیگار،اعتیاد به مصرف الکل،کاهش وزن 1 تا 2 کیلوگرم در یک ماه گذشته ،پیروی از رژیم خاص و یا مصرف داروی خاص،مصرف مکمل رژیمی.
    معیارهای ورود: خانمها در محدوده سنی18 تا 50 سال و نمایه توده بدنی آنها بیشتر یا مساوی 25 و کمتر از 40 معیارهای خروج:بارداری، شیردهی، ابتلا به بیماری های مزمن مثل فشار خون، بیماری های قلبی، دیابت و بیماریهای گوارشی، عادت به کشیدن سیگار،اعتیاد به مصرف الکل،کاهش وزن اخیر حداقل 1 کیلوگرم در سه ماه گذشته ،پیروی از رژیم خاص و یا مصرف داروی خاص،مصرف مکمل رژیمی.
  • General information

    2024-02-20, 1402/12/01
    2025-04-30, 1404/02/10
    2024-09-22, 1403/07/01
    2025-08-30, 1404/06/08
    Change in sample size as well as change in inclusion and exclusion criteria
    Due to problems encountered during sampling and conducting the study, we are requesting changes to some parts of the protocol. Because the patient recruitment has not yet begun, we are requesting a change in the recruitment dates. We also request changes to a number of variables and sample size due to further review of past studies.
    تغییر در حجم نمونه و همچنین تغییر معیارهای ورودی و خروجی
    با توجه به مشکلات پیش آمده در طی نمونه گیری و انجام مطالعه، درخواست تغییرات در برخی از قسمت های پروتکل را داریم. به دلیل اینکه بیمارگیری هنوز شروع نشده است، تقاضای تغییر در تاریخ بیمارگیری را داریم. همچنین به دلیل بررسی بیشتر مطالعات گذشته، درخواست تغییرات در تعدادی از متغیرها و حجم نمونه را داریم.
    مقایسه اثر رژیم روزه داری (فستینگ) متناوب اصلاح شده و رژیم محدودیت کالری روزانه بر شاخص های اشتها، ولع به غذا و رفتار خوردن
    مقایسه اثر رژیم فستینگ متناوب اصلاح شده و رژیم محدودیت کالری روزانه بر شاخص های اشتها، ولع به غذا و رفتار خوردن
    Comparison the effect of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Craving and Eating Behavior of adult obese and/or overweight women aged 18 to 50 years old
    Assessing the Impact of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Cravings, and Eating Habits of Overweight and Obese Women Aged 18 to 50 Years
    مقایسه اثر رژیم روزه داری (فستینگ) متناوب اصلاح شده و رژیم محدودیت کالری روزانه بر شاخص های اشتها، ولع به غذا و رفتار خوردن در زنان بزرگسال چاق و یا دارای اضافه وزن 18 تا 50 سال
    ارزیابی تأثیر رژیم فستینگ متناوب اصلاح شده و رژیم محدودیت کالری روزانه بر شاخص های اشتها، ولع به غذا و رفتار خوردن در زنان بزرگسال چاق و یا دارای اضافه وزن 18 تا 50 سال
    Subjects are selected by a convenient sampling method. Then, participants are divided into control and intervention groups by simple randomization and using the table of random numbers. 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 table of random numbers.
    Participants will be recruited from the Health Centers affiliated with Kashan University of Medical Sciences, utilizing a Simple Random Sampling method that adheres to the predefined inclusion and exclusion criteria. Then, participants are divided into control and intervention groups by simple randomization and using the table of random numbers. 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 table of random numbers.
    انتخاب افراد به صورت نمونه گیری در دسترس انجام میگیرد. سپس با روش تصادفي ساده و به وسیله جدول اعداد تصادفی به گروههای کنترل و مداخله تقسیم می شوند. روش تصادفی سازی بدین صورت است که از ابتدا قرارداد می شود که به گروه مداخله عدد فرد و گروه کنترل عدد زوج داده شود. سپس در جدول اعداد تصادفی، در مورد هر شرکت کننده برحسب اینکه به عدد فرد یا زوج برسیم ، به گروه کنترل یا مداخله اختصاص داده می شوند. واحد تصادفی سازی فردی است
    شرکت کنندگان از مراکز بهداشتی درمانی وابسته به دانشگاه علوم پزشکی کاشان با استفاده از روش نمونه گیری تصادفی ساده که مطابق با معیارهای ورود و خروج از پیش تعریف شده باشند، جذب خواهند شد. سپس با روش تصادفي ساده و به وسیله جدول اعداد تصادفی به گروههای کنترل و مداخله تقسیم می شوند. روش تصادفی سازی بدین صورت است که از ابتدا قرارداد می شود که به گروه مداخله عدد فرد و گروه کنترل عدد زوج داده شود. سپس در جدول اعداد تصادفی، در مورد هر شرکت کننده برحسب اینکه به عدد فرد یا زوج برسیم ، به گروه کنترل یا مداخله اختصاص داده می شوند. واحد تصادفی سازی فردی است
  • Primary outcomes

    #1
    fat free mass
    percentage of body fat
    توده بدون چربی بدن
    درصد چربی بدن
    #2
    empty
    Skeletal muscle mass
    empty
    توده عضلانی اسکلتی
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Inbody device
    empty
    دستگاه Inbody
    #3
    empty
    waist-to-hip circumference ratio
    empty
    نسبت دور کمر به باسن
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Inbody device
    empty
    دستگاه Inbody
  • Secondary outcomes

    #1
    Body Fat Mass
    empty
    توده چربی بدن
    empty
    Beginning and end of the study
    empty
    ابتدا و انتهای مطالعه
    empty
    Inbody device
    empty
    دستگاه Inbody
    empty

Protocol summary

Study aim
To determine the effect of Modified Intermittent Fasting on Appetite, Food Craving and Eating Behavior of adult obese and/or overweight women aged 18 to 50 years old
Design
A randomized, controlled clinical trial has been designed with two parallel groups of 54 patients. Individuals will be recruited utilizing a simple random sampling technique. Then, they are assigned to control (daily calorie restriction diet) and intervention (fasting diet) groups by simple randomization method and using a table of random numbers. Because there is diet intervention, blinding and the trial phase are not applicable.
Settings and conduct
54 obese or overweight women will be selected by a simple random sampling technique based on the inclusion and exclusion criteria of the study from Kashan health centers. Individuals are randomly assigned to one of the two groups of control and intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women in the age range of 18 to 50 years and their body mass index is more than or equal to 25 and less than 40 exclusion criteria: Pregnancy, Breastfeeding, chronic diseases such as high blood pressure, heart disease, diabetes, and gastrointestinal disorders , the habit of smoking, alcohol abuse, recent weight loss of at least 1 kg within the past three months, following a specific diet or taking a specific medication, taking dietary supplements.
Intervention groups
The intervention group: After calculating the daily energy requirement of a person, 25% of the energy is alternately provided one day and 100% of the required energy the next day and follows this diet for 8 weeks. The control group: After calculating the daily energy requirement of a person, 63% of the total energy requirement is provided each day and follows this diet for 8 weeks.
Main outcome variables
Appetite index, Food Craving, Eating Behavior

General information

Reason for update
Due to problems encountered during sampling and conducting the study, we are requesting changes to some parts of the protocol. Because the patient recruitment has not yet begun, we are requesting a change in the recruitment dates. We also request changes to a number of variables and sample size due to further review of past studies.
Acronym
IRCT registration information
IRCT registration number: IRCT20220522054958N2
Registration date: 2022-05-30, 1401/03/09
Registration timing: prospective

Last update: 2025-03-16, 1403/12/26
Update count: 4
Registration date
2022-05-30, 1401/03/09
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
2025-04-30, 1404/02/10
Expected recruitment end date
2025-08-30, 1404/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the Impact of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Cravings, and Eating Habits of Overweight and Obese Women Aged 18 to 50 Years
Public title
Comparison the effect of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Craving and Eating Behavior
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Women in the age range of 18 to 50 years Their body mass index is between 25 and 40.
Exclusion criteria:
Pregnancy Breastfeeding The presence of chronic metabolic conditions like diabetes The existence of cardiovascular disorders such as coronary heart disease and hypertension Gastrointestinal disorders Recent weight loss of at least 1 kg within the past three months Smoking or alcohol abuse Adherence to a specific diet or use of specific medications that may interfere with the trial process The presence of mental or psychological disorders Calorie intake that fall below 80% or exceed 110% of the recommended caloric intake Experiencing severe emotional distress throughout the course of the study Participant unwillingness to continue cooperation or non-adherence to the prescribed diet
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: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be recruited from the Health Centers affiliated with Kashan University of Medical Sciences, utilizing a Simple Random Sampling method that adheres to the predefined inclusion and exclusion criteria. Then, participants are divided into control and intervention groups by simple randomization and using the table of random numbers. 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 table of random numbers.
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
Ethics Committee of Kashan University of Medical Sciences
Street address
5 km Ghotbravandi Blvd, Kashan
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
obese, overweight
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Appetite index
Timepoint
Beginning and end of the study
Method of measurement
Visual Analog Scale

2

Description
Food Craving
Timepoint
Beginning and end of the study
Method of measurement
Food Craving Questionnaire

3

Description
Duch Eating Behavior questionnaire
Timepoint
Beginning and end of the study
Method of measurement
Eating Behavior questionnaire

4

Description
BMI
Timepoint
Beginning and end of the study
Method of measurement
Height: Stadiometer and weight: scales

5

Description
percentage of body fat
Timepoint
Beginning and end of the study
Method of measurement
Inbody device

6

Description
Skeletal muscle mass
Timepoint
Beginning and end of the study
Method of measurement
Inbody device

7

Description
waist-to-hip circumference ratio
Timepoint
Beginning and end of the study
Method of measurement
Inbody device

Secondary outcomes

1

Description
Waist circumference
Timepoint
Beginning and end of the study
Method of measurement
a non-stretchable measuring tape

Intervention groups

1

Description
The intervention group: For calculating the energy requirement, first, the amount of basal metabolic rate is calculated using the Mifflin and then by applying the level of physical activity and the thermic effect of food, the total energy requirement is calculated. 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
The control group: For calculating the energy requirement, first, the amount of basal metabolic rate is calculated using the Mifflin and then by applying the level of physical activity and the thermic effect of food, the total energy requirement is calculated. Then 63% of the calculated energy is provided daily. This diet is followed for 8 weeks.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali Health Center of Kashan
Full name of responsible person
Saeedeh Hosseini Hooshiar
Street address
Niloufar 4th Street, Phase 2, Najiabad Town
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Fax
Email
health_at_kaums@gmail.com
Web page address
http://kaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
5 km Qotb –e Ravandi Blvd., Kashan
City
kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 2999
Email
banafshe57@hotmail.com
Web page address
http://en.kaums.ac.ir
Grant name
Grant code / Reference number
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
Saeedeh Hosseini Hooshiar
Position
MS
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Qutb Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
shoseinih3322@gmail.com
Web page address
http://kaums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Saeedeh Hosseini Hooshiar
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Qutb Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
shoseinih3322@gmail.com
Web page address
http://kaums.ac.ir/

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
Qutb Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
shoseinih3322@gmail.com
Web page address
http://kaums.ac.ir/

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 on Appetite, Food Craving and Eating Behavior ’’. 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.
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