Protocol summary

Study aim
The purpose of this study is to determine the effect of MIND diet on physical fitness and anthropometric factors among female high school students.
Design
This study is a cluster randomized controlled trial
Settings and conduct
In this study, 6 eligible schools will be randomly assigned to one of the intervention and control arms and two types of MIND and control diets will be studied. people will be followed up for 3 months
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. High school girls aged 15 to 17 years 2. Informed consent of participants and their parents Exclusion criteria: 1) Cardiovascular diseases. 2) History of liver disease (alanine aminotransferase (ALT) and aspartate transaminase (AST) more than three times the normal values) and kidney disease (BUN and creatinine values higher than normal). 3) Suffering from cancer or a history of it. 4) suffering from a known cardiovascular disease (coronary artery disease, stroke, congestive heart disease) or a history of heart surgery. 5) having type 2 diabetes (fasting blood sugar above 126) or type 1 diabetes 6) receiving a special diet 7) having any underlying disease 8) people who do professional sports or are athletes 9 ) Allergy to any of the MIND diet components 10) Obese people (above 97th percentile)
Intervention groups
The MIND diet is a combination of the Mediterranean diet and DASH, which will be adjusted according to the ratio of macronutrients: 50-60% carbohydrates, 25-30% fat, and 15-20% protein for the intervention group and the diet of the control group is similar to the typical Iranian diet with a combination of macronutrients. 50 - 60% carbohydrates, 25-30% fat and 15-20% protein
Main outcome variables
Weight, body mass index, waist circumference , body fat percentage, skeletal muscle percentage, cardiorespiratory fitness, anaerobic strength and Handgrip strength

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130223012571N9
Registration date: 2023-10-13, 1402/07/21
Registration timing: prospective

Last update: 2023-10-13, 1402/07/21
Update count: 0
Registration date
2023-10-13, 1402/07/21
Registrant information
Name
Amin Salehi-Abargouei
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
abargouei@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-06, 1402/08/15
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of MIND diet on physical fitness and anthropometric indices in female high school students: a cluster randomized controlled trial
Public title
The effect of MIND diet on physical fitness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
High school girls aged 15 to 17 years Informed consent of participants and their parents Having regular menstruation
Exclusion criteria:
cardiovascular diseases History of liver and kidney disease Suffering from cancer or a history of cancer Having a known cardiovascular disease or a history of heart surgery Having type 2 diabetes (fasting blood sugar above 126) or type 1 diabetes Recipient of a special diet Having any underlying disease People who do professional sports or are athletes Allergy to any of the components of the MIND diet Obese people (over 97th percentile) History of women's diseases and use of hormonal drugs
Age
From 15 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Among the high school girls' schools in Yazd that are eligible to enter the study, 6 schools are randomly selected using SPSS software. 6 envelopes containing intervention or control codes prepared in advance are provided to the investigators. After opening each envelope, the investigators identify each school. In each school, according to the assigned group, 50 students are randomly selected (by generating 50 random numbers and choosing from the list of students of each school) and enter the study.
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 Shahid Sadoughi University of Medical Sciences Yazd
Street address
Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
​8915173160
Approval date
2023-09-11, 1402/06/20
Ethics committee reference number
IR.SSU.SPH.REC.1402.062

Health conditions studied

1

Description of health condition studied
High school girl students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Weight
Timepoint
The beginning and end of the study (after three months)
Method of measurement
A scale with an accuracy of 100 grams

2

Description
waist circumference
Timepoint
The beginning and end of the study (after three months)
Method of measurement
tape measure with an accuracy of 0.5 cm

3

Description
Body mass index
Timepoint
The beginning and end of the study (after three months)
Method of measurement
The ratio of weight to the square of height

4

Description
Percentage of fat mass
Timepoint
The beginning and end of the study (after three months)
Method of measurement
body composition analyzer (Omron)

5

Description
Skeletal muscle percentage
Timepoint
The beginning and end of the study (after three months)
Method of measurement
body composition analyzer (Omron)

6

Description
Cardiorespiratory fitness
Timepoint
The beginning and end of the study (after three months)
Method of measurement
20 m shuttle run test

7

Description
Handgrip strength
Timepoint
The beginning and end of the study (after three months)
Method of measurement
Handgrip

8

Description
Anaerobic power
Timepoint
The beginning and end of the study (after three months)
Method of measurement
Standing broad jump

Secondary outcomes

1

Description
Depression score
Timepoint
The beginning and end of the study (after three months)
Method of measurement
PHQ-9 and DASS-21 questionnaires

2

Description
Anxiety score
Timepoint
The beginning and end of the study (after three months)
Method of measurement
GAD-7 and DASS-21 questionnaires

3

Description
Stress score
Timepoint
The beginning and end of the study (after three months)
Method of measurement
DASS-21 questionnaire

4

Description
Overall health score
Timepoint
The beginning and end of the study (after three months)
Method of measurement
GHQ questionnaire

5

Description
The obtained score of premenstrual syndrome symptoms
Timepoint
The beginning and end of the study (after three months)
Method of measurement
PSST questionnaire

6

Description
The obtained score of menstrual distress
Timepoint
The beginning and end of the study (after three months)
Method of measurement
MMDQ questionnaire

7

Description
sleep quality and quantity
Timepoint
The beginning and end of the study (after three months)
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

8

Description
mental health
Timepoint
The beginning and end of the study (after three months)
Method of measurement
SDQ questionnaire

9

Description
health-related quality of life
Timepoint
The beginning and end of the study (after three months)
Method of measurement
SF-36 questionnaire

Intervention groups

1

Description
Intervention group: Mediterranean-DASH Diet Intervention for Neurodegenerative Delay The MIND diet is a combination of the Mediterranean diet and DASH, which will be adjusted according to the ratio of macronutrients: 50-60% carbohydrates, 25-30% fat, and 15-20% protein for the intervention group. The MIND diet contains high amounts of green leafy vegetables and other vegetables, berries, nuts, olive oil, whole grains, fish, legumes, and poultry.
Category
Lifestyle

2

Description
Control group: he usual diet which is similar to the usual Iranian diet with a macro-nutrient composition of 60-50% of carbohydrates, 25-30% of fats and 15-20% or proteins.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
High schools for girls in Yazd city
Full name of responsible person
Fatemeh Moghtaderi
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd,
City
Yazd
Province
Yazd
Postal code
​8915173160
Phone
+98 35 3820 9100
Email
moghtaderi.fatemeh@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amin Salehi-Abargouei
Street address
Chancellery for research, Central Building of Shahid Sadoughi University of Medical Sciences, Bahonar Square, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3149 2229
Email
abargouei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Moghtaderi
Position
PhD student of nutrition sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
​8915173160
Phone
+98 35 3820 9100
Email
moghtaderi.fatemeh@gmial.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amin Salehi-Abargouei
Position
PhD in Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
​8915173160
Phone
+98 35 3820 9100
Email
abargouei@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Moghtaderi
Position
PhD student of nutrition sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
​8915173160
Phone
+98 35 3149 2229
Email
moghtaderi.fatemeh@gmail.com
Web page address

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
The general characteristics of the participants (without mentioning names and personal information) as well as the data for baseline and post-intervention values for primary and secondary outcomes will be made available to those interested after submitting the researchers' request and reviewing the principal investigators.
When the data will become available and for how long
The data will be available to the researchers when the related articles are published.
To whom data/document is available
The data will be available for all researchers interested in the subject.
Under which criteria data/document could be used
Data will be available if the interested researcher(s) fills the proposal for a joint project and the sponsor of the study (Shahid Sadoughi University of Medical Sciences) confirms the protocol of the project.
From where data/document is obtainable
he data can be obtained from:​Dr. Amin Salehi-Abargouei, Ph.D. in Nutrition Department of Nutrition Faculty of Public Health Sahid Sadoughi University of Medical Sciences Yazd, PO Code 8915173160 Iran Tel:+98-35-31492229 Fax:+98-35-38209119 Email: abargouei@ssu.ac.ir Alternate email: abargouei@gmail.com
What processes are involved for a request to access data/document
The interested investigators should provide a brief description of the data needed and their reason for asking the data by contacting the principal investigator. The principal investigator will assess the possibility of sharing the data and if applicable will ask for a joint proposal. The joint proposal will be sent to the vice chancellery for research, ShahidSadoughi University of Medical Sciences (the sponsor) and the data will be sent by the principal investigator if the sponsor confirms the cooperation.
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