Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Appetite index, Food Craving, Eating Behavior
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-05-30, 1401/03/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-04-30, 1404/02/10
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Expected recruitment end date
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2025-08-30, 1404/06/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Comparison the effect of Modified Intermittent Fasting and Daily Calorie Restriction on Appetite, Food Craving and Eating Behavior
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-04-17, 1401/01/28
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1401.002
Health conditions studied
1
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Description of health condition studied
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obese, overweight
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Appetite index
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Timepoint
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Beginning and end of the study
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Method of measurement
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Visual Analog Scale
2
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Description
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Food Craving
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Timepoint
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Beginning and end of the study
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Method of measurement
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Food Craving Questionnaire
3
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Description
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Duch Eating Behavior questionnaire
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Timepoint
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Beginning and end of the study
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Method of measurement
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Eating Behavior questionnaire
4
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Description
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BMI
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Timepoint
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Beginning and end of the study
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Method of measurement
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Height: Stadiometer and weight: scales
5
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Description
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percentage of body fat
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Timepoint
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Beginning and end of the study
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Method of measurement
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Inbody device
6
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Description
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Skeletal muscle mass
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Timepoint
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Beginning and end of the study
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Method of measurement
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Inbody device
7
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Description
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waist-to-hip circumference ratio
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Timepoint
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Beginning and end of the study
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Method of measurement
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Inbody device
Secondary outcomes
1
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Description
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Waist circumference
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Timepoint
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Beginning and end of the study
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Method of measurement
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a non-stretchable measuring tape
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Six months after publishing results, everything will be accessible.
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To whom data/document is available
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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
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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All applicants can contact Dr. Sadegh Jafarnejad through e-mail drsadegh2008@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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