Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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Participants are selected from the Health Centers of Kashan University of Medical Sciences by convenient sampling. Participants are randomly assigned into two groups.
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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 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
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Intervention groups
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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.
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Main outcome variables
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The sleep quality؛ daytime sleepiness؛ insomnia؛ BMI؛ FFM؛ and the body fat mass
General information
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Reason for update
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Due to the delay in the recruitment dates, we request to change the expected recruitment start date.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-07-08, 1401/04/17
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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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2022-09-01, 1401/06/10
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Expected recruitment end date
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2022-12-30, 1401/10/09
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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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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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Public title
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The effect of Modified Intermittent Fasting Diet on sleep quality and anthropometric indices of obese and/or overweight adult women
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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
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
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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:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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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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overweight
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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Obesity
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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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Sleep quality
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Timepoint
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The beginning and end of the study
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Method of measurement
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Pittsburgh Sleep Quality questionnaire
2
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Description
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daytime sleepiness
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Timepoint
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The beginning and end of the study
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Method of measurement
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Epworth Sleepiness questionnaire
3
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Description
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Insomnia
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Timepoint
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The beginning and end of the study
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Method of measurement
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Insomnia Severity questionnaire
4
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Description
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BMI
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Timepoint
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The beginning and end of the study
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Method of measurement
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Height: stadiometer, Weight: scale
5
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Description
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Free fat mass FM and the body fat mass
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Timepoint
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The 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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The body fat mass
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Timepoint
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The 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 circumference
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Timepoint
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The beginning and end of the study
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Method of measurement
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non-stretchable measuring tape
8
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Description
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The waist-to-hip ratio
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Timepoint
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The beginning and end of the study
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Method of measurement
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by dividing the waist circumference by the hip circumference
9
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Description
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weight
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Timepoint
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The beginning and end of the study
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Method of measurement
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scales
Secondary outcomes
1
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Description
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The hip circumference
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Timepoint
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The beginning and end of the study
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Method of measurement
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non-stretchable measuring tape
2
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Description
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visceral fat area
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Timepoint
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The beginning and end of the study
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Method of measurement
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Inbody device
3
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Description
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The percent body fat
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Timepoint
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The beginning and end of the study
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Method of measurement
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Inbody device
4
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Description
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The soft lean mass
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Timepoint
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The beginning and end of the study
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Method of measurement
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Inbody device
5
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Description
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The skeletal muscle mass
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Timepoint
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The 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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the extracellular water ratio
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Timepoint
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The 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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The total body water
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Timepoint
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The beginning and end of the study
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Method of measurement
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Inbody device
8
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Description
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Subjective sleep quality (SSQ)
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Timepoint
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The beginning and end of the study
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Method of measurement
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Pittsburgh Sleep Quality Index (PSQI) questionnaire
9
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Description
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Sleep latency
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Timepoint
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The beginning and end of the study
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Method of measurement
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Pittsburgh Sleep Quality Index (PSQI) questionnaire
10
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Description
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Sleep duration
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Timepoint
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The beginning and end of the study
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Method of measurement
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Pittsburgh Sleep Quality Index (PSQI) questionnaire
11
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Description
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Habitual sleep efficiency
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Timepoint
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The beginning and end of the study
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Method of measurement
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Pittsburgh Sleep Quality Index (PSQI) questionnaire
12
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Description
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Sleep disturbances
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Timepoint
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The beginning and end of the study
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Method of measurement
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Pittsburgh Sleep Quality Index (PSQI) questionnaire
13
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Description
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use of sleeping medication
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Timepoint
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The beginning and end of the study
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Method of measurement
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Pittsburgh Sleep Quality Index (PSQI) questionnaire
14
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Description
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daytime dysfunction
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Timepoint
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The beginning and end of the study
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Method of measurement
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Pittsburgh Sleep Quality Index (PSQI) questionnaire
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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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 Diet on sleep quality and anthropometric indices ’’. 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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