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
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General information
56
54
5654
Change in expected recruitment start date and expected recruitment end date and also change of some primary and secondary outcomes
Change in sample size as well as change in inclusion and exclusion criteria
Change in expected recruitment start datesample size as well as change in inclusion and expected recruitment end date and also change of some primary and secondary outcomesexclusion criteria
تغییر در تاریخ شروع بیمارگیری مورد انتظار و تاریخ پایان بیمارگیری مورد انتظار و همچنین تغییر برخی از پیامدهای اولیه و ثانویه
تغییر در حجم نمونه و همچنین تغییر معیارهای ورودی و خروجی
تغییر در تاریخ شروع بیمارگیری مورد انتظار و تاریخ پایان بیمارگیری مورد انتظارحجم نمونه و همچنین تغییر برخی از پیامدهای اولیهمعیارهای ورودی و ثانویهخروجی
Women in the age range of 18 to 50 years
Their body mass index is more than or equal to 25 and less than 40
Women in the age range of 18 to 50 years
Their body mass index is between 25 and 40.
Women in the age range of 18 to 50 years Their body mass index is more than or equal tobetween 25 and less than 40.
خانمها در محدوده سنی18 تا 50 سال
نمایه توده بدنی آنها بیشتر یا مساوی 25 و کمتر از 40 باشد.
خانمها در محدوده سنی18 تا 50 سال
شاخص توده بدنی آنها بین 25 تا 40 است.
خانمها در محدوده سنی18 تا 50 سال نمایهشاخص توده بدنی آنها بیشتر یا مساویبین 25 و کمتر ازتا 40 باشداست.
Pregnancy
Breastfeeding
Chronic diseases such as high blood pressure, heart disease, diabetes, 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
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
Pregnancy Breastfeeding Chronic diseasesThe presence of chronic metabolic conditions like diabetes The existence of cardiovascular disorders such as high blood pressure,coronary heart disease, diabetes, gastrointestinal and hypertension Gastrointestinal disorders The habitRecent weight loss of smokingat least 1 kg within the past three months Smoking or alcohol abuse Weight loss of 1Adherence to 2 kg in the past month Following a specific diet or taking ause of specific medication Taking dietary supplementsmedications 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
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
بارداری
شیردهی
وجود شرایط متابولیک مزمن مانند دیابت
وجود اختلالات قلبی عروقی مانند بیماری عروق کرونر قلب و فشار خون بالا
اختلالات دستگاه گوارش
کاهش وزن اخیر حداقل 1 کیلوگرم در سه ماه گذشته
سیگار کشیدن یا سوء مصرف الکل
پیروی از یک رژیم غذایی خاص یا استفاده از داروهای خاص که ممکن است در روند آزمایش اختلال ایجاد کند
وجود اختلالات ذهنی یا روانی
کالری دریافتی که کمتر از 80 درصد یا بیشتر از 110 درصد کالری دریافتی توصیه شده است.
تجربه استرس شدید عاطفی در طول دوره مطالعه
عدم تمایل شرکت کننده به ادامه همکاری یا عدم پایبندی به رژیم غذایی تجویز شده
بارداری شیردهی ابتلا بهوجود شرایط متابولیک مزمن مانند دیابت وجود اختلالات قلبی عروقی مانند بیماری های مزمن مثلعروق کرونر قلب و فشار خون، بیماری های قلبی، دیابت و بیماریهای گوارشی عادت به بالا اختلالات دستگاه گوارش کاهش وزن اخیر حداقل 1 کیلوگرم در سه ماه گذشته سیگار کشیدن سیگار اعتیاد بهیا سوء مصرف الکل کاهش وزن 1 تا 2 کیلوگرم در یک ماه گذشته پیروی از یک رژیم غذایی خاص ویا استفاده از داروهای خاص که ممکن است در روند آزمایش اختلال ایجاد کند وجود اختلالات ذهنی یا مصرف داروی خاص مصرف مکمل رژیمیروانی کالری دریافتی که کمتر از 80 درصد یا بیشتر از 110 درصد کالری دریافتی توصیه شده است. تجربه استرس شدید عاطفی در طول دوره مطالعه عدم تمایل شرکت کننده به ادامه همکاری یا عدم پایبندی به رژیم غذایی تجویز شده
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 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.
Settings and conduct
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.
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, weight loss of 1 to 2 kg in the past month, 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
Change in sample size as well as change in inclusion and exclusion criteria
Acronym
IRCT registration information
IRCT registration number:IRCT20220522054958N2
Registration date:2022-05-30, 1401/03/09
Registration timing:prospective
Last update:2024-02-29, 1402/12/10
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
2024-02-20, 1402/12/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
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
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.
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
fat free mass
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
2
Description
Body Fat Mass
Timepoint
Beginning and end of the study
Method of measurement
Inbody device
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.