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Investigating the effect of Dietary Approaches to Stop Hypertension diet on stress, depression, quality of life and sleep status of students and their families: A randomized clinical trial

Protocol summary

Study aim
This study aimed to investigate the effect of DASH diet prescription compared with standard diet on levels of depression, anxiety, stress, quality of life, sleep quantity and quality among students and their families
Design
A two-arm, randomized parallel controlled clinical trial. A total of 400 eligible participants will be assigned to two intervention groups (n=200) using simple randomization.
Settings and conduct
This study will be conducted in the Nutrition and Food Security research center, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. A total of 400 eligible individuals will be randomly assigned to two groups (n=200) in which they will receive recommendations of DASH or standard diets for six months. Depression, stress, anxiety, quality of life, adherence to diet, sleep quantity and quality will be assessed at baseline and 6 month later
Participants/Inclusion and exclusion criteria
Inclusion criteria: undergraduate nutrition students and their families (over 12 years old) which give consent to enter the study Exclusion criteria: past history of cancer, autoimmune diseases, inflammatory bowel disease, chronic or acute renal disease (creatinine ≥ 1.4 mg / dL for men or 1.3 for women or proteinuria) and anti-psychotic drugs use in past 6 months
Intervention groups
Intervention group: the individuals will receive DASH diet. The participants will be trained DASH diet in four online sessions. They will receive dietary recommendations during intervention period. Control group: the individuals will receive standard diet. The study participants will be trained standard diet recommendations in four online sessions. They will receive dietary recommendations during intervention period. The duration of the intervention and study will be 6 months
Main outcome variables
Depression, Anxiety, Stress, Sleep Quality, Sleep quantity, Quality of Life, Adherence to diet

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210427051098N1
Registration date: 2021-10-10, 1400/07/18
Registration timing: prospective

Last update: 2021-10-10, 1400/07/18
Update count: 0
Registration date
2021-10-10, 1400/07/18
Registrant information
Name
Sayyed Saeid Khayyatzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 9100
Email address
khayyatzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-22, 1400/09/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Dietary Approaches to Stop Hypertension diet on stress, depression, quality of life and sleep status of students and their families: A randomized clinical trial
Public title
The effect of Dietary Approaches to Stop Hypertension diet on mental health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Undergraduate nutrition students and their families (over 12 years old) Completion of informed consent
Exclusion criteria:
Pregnancy and lactation Suffering from cancer Suffering from autoimmune diseases Suffering from inflammatory bowel disease Chronic or acute kidney disease (creatinine ≥ 1.4 mg / dL for men or ≥ 1.3 for women or proteinuria) Hospitalization for more than 2 weeks
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 400
Randomization (investigator's opinion)
Randomized
Randomization description
After determining the eligible people and obtaining their consent, the participants will be divided into two groups [intervention (DASH diet) or control (standard diet)] by random allocation method. Firstly, each individual will receive a specific code number. Then all code numbers will be entered to random allocation software. Software inputs will include the total number of samples and the number of treatment groups (intervention and control). The software output will include random numbers assigned to two groups. The allocation ratio will be 1:1. Each participant will have an equal chance of being in each group, and participants in the study will not be able to predict the type of intervention they receive.
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
Central Building of Shahid Sadoughi University of Medical Sciences, Yazd, Bahonar Square, Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2021-02-03, 1399/11/15
Ethics committee reference number
IR.SSU.SPH.REC.1399.244

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features

2

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

3

Description of health condition studied
Sleep disorders
ICD-10 code
F51
ICD-10 code description
Sleep disorders not due to a substance or known physiological condition

4

Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia

5

Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

6

Description of health condition studied
Stress
ICD-10 code
F54
ICD-10 code description
Psychological and behavioral factors associated with disorders or diseases classified elsewhere

7

Description of health condition studied
Quality of life
ICD-10 code
F54
ICD-10 code description
Psychological and behavioral factors associated with disorders or diseases classified elsewhere

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention, 6 months after the intervention
Method of measurement
DASS-21 validated questionnaire

2

Description
depression
Timepoint
Before the intervention, 6 months after the intervention
Method of measurement
Beck and DASS-21 validated questionnaires

3

Description
Sleep quality
Timepoint
Before the intervention, 6 months after the intervention
Method of measurement
Pittsburgh Validated Questionnaire

4

Description
Stress
Timepoint
Before the intervention, 6 and 12 months after the intervention
Method of measurement
DASS-21 validated questionnaire

5

Description
Quality of life
Timepoint
Before the intervention, 6 and 12 months after the intervention
Method of measurement
SF-12 validated questionnaire

6

Description
Excessive daytime sleepiness
Timepoint
Before the intervention, 6 and 12 months after the intervention
Method of measurement
Epworth Sleepiness Scale validated questionnaire

7

Description
dyspepsia
Timepoint
Before the intervention, 6 and 12 months after the intervention
Method of measurement
Rome IV questionnaire

8

Description
Irritable bowel syndrome
Timepoint
Before the intervention, 6 and 12 months after the intervention
Method of measurement
Rome IV questionnaire

Secondary outcomes

1

Description
Weight
Timepoint
Before the intervention, 6 and 12 months after the intervention
Method of measurement
Weighting scale

2

Description
Body mass index (BMI)
Timepoint
Before the intervention, 6 and 12 months after the intervention
Method of measurement
Ratio of weight to height squared

Intervention groups

1

Description
Intervention group: in this group, the individuals will receive dietary approach to stop hypertension (DASH) diet which including 18% protein, 27% fat and 55% carbohydrate. At first, the study participants will be trained DASH diet recommendations in four online sessions of 2 hour each. Then, the individuals will weekly receive DASH recommendations through communication software during intervention. The individuals will be encouraged to consume more amount of whole grains, low-fat foods, fish, chicken, lean beef and eggs (to reduce the intake of saturated fat and cholesterol), low-fat dairy products, seeds and nuts, fruits and vegetables high in potassium (with emphasis on sources of key nutrients in the DASH diet). We will recommend individuals to limit intake of processed foods, which have high calorie density and are rich in fats, sugars and sodium. Sodium intake will be limited to 2,400-3,000 mg/day. The required energy of each person will be determined based on Harris Benedict formula. If a person is overweight or obese, the patient's calculated energy will be reduced by 500 kcal. The dietary plan will prescribe individually. The duration of the study and intervention will be 6 months. Training sessions will be held once a week in the first month. Contents of the first session: Principles of DASH diet and calculation of calorie intake, Session 2: Carbohydrate sources of DASH diet, Session 3: Protein sources of DASH diet, Fourth session: Fat sources of DASH diet and sodium and sugar restriction of diet.
Category
Behavior

2

Description
Control group: In this group, the individuals will receive standard diet which including 15% protein, 30% fat and 55% carbohydrate. At first, the study participants will be trained standard diet recommendations in four online sessions of 2 hour each. Then, the individuals will weekly receive standard diet recommendations through communication software during intervention. The amount of calories is the same as the intervention group, but differs from the intervention group in terms of the number of food group units. Diet low in sugar and fat will be recommended. We will not have any recommendation about sodium or potassium intakes. The required energy of each person will be determined based on Harris Benedict formula. If a person is overweight or obese, the patient's calculated energy will be reduced by 500 kcal. The dietary plan will prescribe individually. Contents of the first session: Food groups and calculation of calorie intake, Session 2: Importance of cereals, legumes and sugar in diet, Session 3: the role of dairy products, meat and oil in human health, Fourth session: importance of fruits and vegetables in human health.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Street address
Shahid Sadoughi university of medical sciences, Shohadaye gomnam Blvd, Alem square,
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
khayyatzadeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Square.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3146 2136
Email
mmirzaei@ssu.ac.ir
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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Sayyed Saeid Khayyatzadeh
Position
Assistant professor in nutrition
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Sadoughi University of Medical Sciences, Alem Square.
City
Yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
khayyatzadeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Saeed Khayatzadeh
Position
Assistant Professor
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.
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
khayyatzadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Saeed Khayatzadeh
Position
Assistant Professor
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.
City
yazd
Province
Yazd
Postal code
8915173160
Phone
+98 35 3820 9100
Email
khayyatzadeh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
primary outcome will be available at the end of study
When the data will become available and for how long
From January 2023
To whom data/document is available
Academic institutions
Under which criteria data/document could be used
Academic institutes can send their official request to the email of the scientific director of the project. the data will be sent after confirmation of ethics committee of shahid sadoughi university of medical sciences. It is not possible to perform statistical analysis on the data.
From where data/document is obtainable
Sayyed Saeid Khayyatzadeh Assistant professor of nutrition in Shahid Sadoughi university of medical sciences Khayyatzadeh@yahoo.com 00983538209100
What processes are involved for a request to access data/document
Academic institutes can send their official request to the email of the scientific director of the project. The data will be sent after confirmation of ethics committee of Shahid Sadoughi university of medical sciences
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