]>
IRCT20210427051098N4 IRCT 2023-12-01 Yazd University of Medical Sciences Investigating the effect of diet consumption based on high adherence to the global diet quality score on the control of sugar factors, mental health and anthropometric indicators in patients with type 2 diabetes Investigating the effect of consuming a diet based on high adherence to the Global Diet Quality Score (GDQS) with a standard diet on the control of sugar factors, mental health and anthropometric indicators in patients with type 2 diabetes: a randomized clinical trial 2023-12-22 anticipated 134 Complete https://irct.ir/trial/73088 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization based on gender (male and female) and BMI (above and below 25) as randomization stratified randomization with a block size equal to 8 and 2 times will be repeated. The group assigned to the people will be placed in sealed envelopes in advance and then when the participant visits and after the approval of the eligible The condition of entering the study is that the envelope will be opened and will be placed in the designated group. N/A diabetes. Intervention 1: Intervention group:In the diet group based on the GDQS index, people with type 2 diabetes were given GDQS diet training for 3 sessions (the first week before the start of the intervention, the fourth week, and the eighth week of the intervention) and each session lasted 30 minutes. they take. People with type 2 diabetes will be randomly selected and placed in the standard or GDQS group. If there were two participants from the same family with type 2 diabetes, both would be randomly assigned to the standard or GDQS group. The amount of prescribed energy intake for people is calculated according to the Harris-Benedict equation. If the body mass index of people is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. The weight loss phase for overweight and obese people ends immediately after reaching a body mass index of less than 25. People will be taught how to cook different foods according to dietary recommendations. Diet recommendations based on GDQS will be adjusted according to the amount of energy needed by the person, which for a diet containing 1600 calories, 6-8 servings of fruits and vegetables per day, 7-8 servings of nuts and seeds per week, at least 6.5 servings of grains (half 2-3 daily servings of non-fat and low-fat dairy products, maximum 150 grams of meat (with an emphasis on fish and chicken), will be recommended. In training sessions, dietary recommendations based on GDQS will be fully explained to people. These recommendations will be based on the economic status of people's access to food and the status of some other diseases such as digestive diseases. Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call. People are taught to consume a piece of fruit, a glass of drink with barley bread or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion). Intervention 2: Control group:Prescribing diet in the standard group: the amount of prescribed energy intake for people is calculated according to the Harris-Benedict equation. If the body mass index of people is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. The weight loss phase for overweight and obese people ends immediately after reaching a body mass index of less than 25. People will be taught how to cook different foods according to dietary recommendations. The recommendations of the control diet will be adjusted according to the amount of energy needed by the individual and will contain 55% carbohydrates, 15% protein, 30% fat, and less than 5% energy from simple sugars. These recommendations will be based on the economic status of people's access to food and the status of some other diseases such as digestive diseases. Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call. The number of training sessions in the standard diet group will be 3 sessions (the first week before the intervention, the fourth week, and the eighth week of the intervention) and healthy food recommendations will be taught to people. People are taught to consume a piece of fruit, a glass of drink with barley bread, or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion). People with type 2 diabetes are randomly placed in this group. 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 2024 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 Sara Bagherpour
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3149 2228 sarabagherpour1376@gmail.com Yazd University of Medical Sciences scientific Sayyed Saeid Khayyatzadeh
Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Alam Square, Yazd City
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3149 2228 khayyatzadeh@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) Participants with type 2 diabetes Fasting blood glucose level ≥ 126 mg/dL The two-hour plasma glucose level ≥200 mg/dL Consumption of oral hypoglycemic medications Body mass index (BMI) ≤ 40 kg/m2 Completion of informed consent 18 years no limit Both Uncontrolled diabetes (HbA1C more than 9 mg/dl) Suffering from diabetic nephropathy History of ischemic heart disease pregnancy Lactation History of hospitalization for the treatment of heart disease during the last 6 months History of cancer treatment in the last 5 years Suffering from proteinuria History of steroid treatment during the last 3 months Suffering from thyroid disease History of lung disease and compliance with special diet Suffering from hepatitis Suffering from gastrointestinal disease Suffering from pancreatitis Suffering from inflammatory bowel disease Bowel resection Infected with AIDS Suffering from acute mental disorders Suffering from Cushing's syndrome Alcohol consumption Drug abuse Taking thiazide diuretics Taking antidepressants E11 Type 2 diabetes mellitus N/A N/A Intervention group:In the diet group based on the GDQS index, people with type 2 diabetes were given GDQS diet training for 3 sessions (the first week before the start of the intervention, the fourth week, and the eighth week of the intervention) and each session lasted 30 minutes. they take. People with type 2 diabetes will be randomly selected and placed in the standard or GDQS group. If there were two participants from the same family with type 2 diabetes, both would be randomly assigned to the standard or GDQS group. The amount of prescribed energy intake for people is calculated according to the Harris-Benedict equation. If the body mass index of people is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. The weight loss phase for overweight and obese people ends immediately after reaching a body mass index of less than 25. People will be taught how to cook different foods according to dietary recommendations. Diet recommendations based on GDQS will be adjusted according to the amount of energy needed by the person, which for a diet containing 1600 calories, 6-8 servings of fruits and vegetables per day, 7-8 servings of nuts and seeds per week, at least 6.5 servings of grains (half 2-3 daily servings of non-fat and low-fat dairy products, maximum 150 grams of meat (with an emphasis on fish and chicken), will be recommended. In training sessions, dietary recommendations based on GDQS will be fully explained to people. These recommendations will be based on the economic status of people's access to food and the status of some other diseases such as digestive diseases. Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call. People are taught to consume a piece of fruit, a glass of drink with barley bread or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion) Control group:Prescribing diet in the standard group: the amount of prescribed energy intake for people is calculated according to the Harris-Benedict equation. If the body mass index of people is less than 25, the current weight of people is used to calculate energy; But if the body mass index is more than 25, the adjusted weight of people according to the body mass index of 25 is used to calculate energy. The weight loss phase for overweight and obese people ends immediately after reaching a body mass index of less than 25. People will be taught how to cook different foods according to dietary recommendations. The recommendations of the control diet will be adjusted according to the amount of energy needed by the individual and will contain 55% carbohydrates, 15% protein, 30% fat, and less than 5% energy from simple sugars. These recommendations will be based on the economic status of people's access to food and the status of some other diseases such as digestive diseases. Also, people will be taught how to cook different foods according to dietary recommendations. People's adherence to the diet will be checked once a week through a phone call. The number of training sessions in the standard diet group will be 3 sessions (the first week before the intervention, the fourth week, and the eighth week of the intervention) and healthy food recommendations will be taught to people. People are taught to consume a piece of fruit, a glass of drink with barley bread, or crispy bread when mild hypoglycemic symptoms occur (hunger, sweating, increased heart rate, and confusion). People with type 2 diabetes are randomly placed in this group HBA1C. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood test. Fasting Plasma Glucose (FPG). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample. Insulin. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample. Insulin resistance index. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Formula. Triacyl glyceride (TG). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample. Total cholesterol. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample. High Density Lipoprotein (HDL). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample. Low Density Lipoprotein (LDL). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Blood sample. Anxiety. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Beck validated questionnaire. Depression. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Beck validated questionnaire. Sleep quality. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Pittsburgh validated questionnaire. Quality of Life. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: SF-36 validated questionnaire. Height. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Tape measure. Weight. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Weighting scale. Body Mass Index (BMI). Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Body composition analyzer. Waist circumference. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Tape measure. Hips circumference. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Tape measure. Fat mass. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Body composition analyzer. Fat free mass. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Body composition analyzer. Blood pressure. Timepoint: Before the intervention, 12 weeks after the intervention. Method of measurement: Measurement of systolic and diastolic blood pressure (mmHg). Yazd University of Medical Sciences Approved 2023-11-25 Ethics Committee of Shahid Sadoughi University of Medical Sciences Shahid Sadoughi University of Medical Sciences and Health Services Campus- Shohadaye Gomnam Blvd- Alem Square- Yazd Yazd Yazd Iran (Islamic Republic of)