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IRCT20210427051098N1 IRCT 2021-10-10 Yazd University of Medical Sciences The effect of Dietary Approaches to Stop Hypertension diet on mental health 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 2021-11-22 anticipated 400 Complete https://irct.ir/trial/55994 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Condition 1: Depression. Condition 2: Anxiety. Condition 3: Sleep disorders. Condition 4: Dyspepsia. Condition 5: Irritable bowel syndrome. Condition 6: Stress. Condition 7: Quality of life. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: primary outcome will be available at the end of study When: From January 2023 To whom: Academic institutions Conditions: 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. Where to obtain: Sayyed Saeid Khayyatzadeh Assistant professor of nutrition in Shahid Sadoughi university of medical sciences Khayyatzadeh@yahoo.com 00983538209100 How to obtain: 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 Comments:
public Sayyed Saeid Khayyatzadeh
Shahid Sadoughi University of Medical Sciences, Alem Square.
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 khayyatzadeh@yahoo.com Shahid Sadoughi University of Medical Sciences scientific Seyed Saeed Khayatzadeh
Department of Nutrition, Faculty of Public Health, Shahid Sadughi University of Medical Sciences, Alem Square.
yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 khayyatzadeh@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Undergraduate nutrition students and their families (over 12 years old) Completion of informed consent 12 years no limit Both 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 F06.31 F06.4 F51 K30 K58 F54 F54 Mood disorder due to known physiological condition with depressive features Anxiety disorder due to known physiological condition Sleep disorders not due to a substance or known physiological condition Functional dyspepsia Irritable bowel syndrome Psychological and behavioral factors associated with disorders or diseases classified elsewhere Psychological and behavioral factors associated with disorders or diseases classified elsewhere Behavior Behavior 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. 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. Anxiety. Timepoint: Before the intervention, 6 months after the intervention. Method of measurement: DASS-21 validated questionnaire. Depression. Timepoint: Before the intervention, 6 months after the intervention. Method of measurement: Beck and DASS-21 validated questionnaires. Sleep quality. Timepoint: Before the intervention, 6 months after the intervention. Method of measurement: Pittsburgh Validated Questionnaire. Stress. Timepoint: Before the intervention, 6 and 12 months after the intervention. Method of measurement: DASS-21 validated questionnaire. Quality of life. Timepoint: Before the intervention, 6 and 12 months after the intervention. Method of measurement: SF-12 validated questionnaire. Excessive daytime sleepiness. Timepoint: Before the intervention, 6 and 12 months after the intervention. Method of measurement: Epworth Sleepiness Scale validated questionnaire. Dyspepsia. Timepoint: Before the intervention, 6 and 12 months after the intervention. Method of measurement: Rome IV questionnaire. Irritable bowel syndrome. Timepoint: Before the intervention, 6 and 12 months after the intervention. Method of measurement: Rome IV questionnaire. Weight. Timepoint: Before the intervention, 6 and 12 months after the intervention. Method of measurement: Weighting scale. Body mass index (BMI). Timepoint: Before the intervention, 6 and 12 months after the intervention. Method of measurement: Ratio of weight to height squared. Yazd University of Medical Sciences Approved 2021-02-03 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Central Building of Shahid Sadoughi University of Medical Sciences, Yazd, Bahonar Square, Shahid Sadoughi Blvd Yazd Yazd Iran (Islamic Republic of)