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
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
Acronym
IRCT registration information
IRCT registration number:IRCT20220522054958N2
Registration date:2022-05-30, 1401/03/09
Registration timing:prospective
Last update:2022-05-30, 1401/03/09
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
2022-06-10, 1401/03/20
Expected recruitment end date
2022-08-11, 1401/05/20
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 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
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
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 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
Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715973474
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
Eating Behavior
Timepoint
Beginning and end of the study
Method of measurement
Three-Factor Eating Questionnaire-R21
Secondary outcomes
1
Description
Body mass index
Timepoint
Beginning and end of the study
Method of measurement
height: stadiometer and weight: scales
2
Description
Waist circumference
Timepoint
Beginning and end of the study
Method of measurement
a non-stretchable measuring tape
3
Description
fat free mass
Timepoint
Beginning and end of the study
Method of measurement
Inbody device
4
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
The Health Centers of Kashan
Full name of responsible person
Saeedeh Hosseini Hooshiar
Street address
Kashan University of Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Fax
Email
shoseinih3322@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
Kashan University of Medical Science
City
kashan
Province
Isfehan
Postal code
8715973474
Phone
+98 31 5544 3022
Email
shoseinih3322@gmail.com
Web page address
http://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)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available