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IRCT20181118041687N1 IRCT 2020-09-30 Larestan University of Medical Sciences The Effect of Nutrition Education in Women with type 2 Diabetes. The Effect of Nutrition Education on Control Blood Sugar, Lipid Profile, liver Enzymes and Quality of life in Middle-aged Women with type 2 Diabetes. 2018-06-15 anticipated 100 Complete https://irct.ir/trial/35342 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Qualified individuals were randomly assigned to intervention and control groups. (block balanced randomization). First, I wrote the letters A and B twice on six pieces of paper and put them in a container. Each time I referred, I took a piece of paper at random so that the fourth person could be identified in which group, then I put the paper in the container again I categorized those people into groups A (intervention) and B (control), Blinding description: Only participants are unaware of the allocation of the study groups. The principal investigator is aware of the assignment of groups. The members of the intervention group were contacted confidentially and were invited to attend training classes. The control group received training after completing the study. N/A Diabetes type 2. Intervention 1: Intervention group: Educational intervention with 4 sessions of nutrition training class in groups of 5-10 people with educational content of sessions including: stages of diabetes progression, symptoms of each stage and its side effects, providing nutritional recommendations to control diabetes and the importance of diet. Food groups and emphasis on increasing the number of meals, reducing the consumption of fats and simple carbohydrates, consuming whole grains and increasing the consumption of fruits and vegetables were held for the intervention group during three months. The average time per session was 70 minutes. The first session at the beginning of the study and in the form of an interactive lecture; The second session was held two weeks after the start of the study by small group techniques, the third session was held four weeks after the start of the study as an interactive lecture and the fourth session was held six weeks after the start of the study by lecture method. It was done by phone and all the recommendations were briefly reminded to the patient again. Intervention 2: Control group:Educational intervention with 4 sessions of nutrition training class in groups of 5-10 people with educational content of sessions including: stages of diabetes progression, symptoms of each stage and its complications, providing nutritional recommendations to control diabetes and the importance of diet. They did not receive any intervention during these three months and were asked not to change their physical activity and diet during this period. But after the intervention, they received all the training provided to the intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Elham Dezhaloon
Lar-The old city-square hozeh elmiye-Plaque3
Lar Iran (Islamic Republic of) 74319-85679 +98 71 5888 8105 dezhalooneli@yahoo.com Shiraz University of Medical Sciences scientific Elham Dezhaloon
Lar-The old city-square hozeh elmiye-Plaque3
Lar Iran (Islamic Republic of) 74319-85679 +98 71 5888 8105 dezhalooneli@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Middle Aged WWomen are 30 to 59 Years Old. Have a one Year or more History of type 2 Diabetes. Willing to Participate in the Study. Use Oral Medications to Control your Blood Sugar. Do not take Insulin. Pregnant and lactating. Do not have any Special iIlnesses. Have no Thyroid Problems. There is no Definite Diet. Do not have Uncontrolled Diabetes. Have Mental Disabilities. Sleep, Tranquilizer, Antihistamines and Immune System Inhibitors. 30 years 59 years Female One does not want to Continue to Study. The Person will Absent more than one Meeting. The Person leaves the Pre-test or Post-test. Tests are Misleading. E11 Type 2 diabetes mellitus Lifestyle Lifestyle Intervention group: Educational intervention with 4 sessions of nutrition training class in groups of 5-10 people with educational content of sessions including: stages of diabetes progression, symptoms of each stage and its side effects, providing nutritional recommendations to control diabetes and the importance of diet. Food groups and emphasis on increasing the number of meals, reducing the consumption of fats and simple carbohydrates, consuming whole grains and increasing the consumption of fruits and vegetables were held for the intervention group during three months. The average time per session was 70 minutes. The first session at the beginning of the study and in the form of an interactive lecture; The second session was held two weeks after the start of the study by small group techniques, the third session was held four weeks after the start of the study as an interactive lecture and the fourth session was held six weeks after the start of the study by lecture method. It was done by phone and all the recommendations were briefly reminded to the patient again. Control group:Educational intervention with 4 sessions of nutrition training class in groups of 5-10 people with educational content of sessions including: stages of diabetes progression, symptoms of each stage and its complications, providing nutritional recommendations to control diabetes and the importance of diet. They did not receive any intervention during these three months and were asked not to change their physical activity and diet during this period. But after the intervention, they received all the training provided to the intervention group. Fasting blood glucose above 126mg / dl and high blood glucose levels of 180mg / dl. Timepoint: The beginning of the study (before intervention) and three months after the intervention began. Method of measurement: blood test. Hemogolobin A1C above 6.5%. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Koromatografi. Fasting Ansulin. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Fasting serum insulin concentration using a commercial kit. Weight. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Weight using seca scales with an accuracy of one hundred grams. Waist. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Scales. Body mass index. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Ratio of weight(in terms of kilogram) to the power of height(in terms of meters). Blood pressure. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Using a standard mercury barometer. High density of lipoprotein cholestrol. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Blood test. Low density of lipoprotein cholestrol. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Blood test. Triglyceride. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Blood test. Cholesterol. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Blood test. Alanine trans aminase. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Blood test. Aspartate transaminase. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Blood test. Homeostasis model assessment beta cell. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Based on fasting glucose and insulin concentrations. Homeostasis model assessment insulin resistance. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Based on fasting glucose and insulin concentrations. Quantitative insulin sensitivity check index. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Based on fasting glucose and insulin concentrations. The level of awareness of people. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Questionnaire of Dr. Faqih et al. Quality of life. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Twelve quality of life questionnaire. Get food. Timepoint: Three reminders at the beginning of the intervention and three reminders after the end of the educational intervention (Three months after the start of the training intervention). Method of measurement: Using a 24-hour recall form. Physical activity. Timepoint: The bigining of the study (befor intervention) and teree monthe after the intervention began. Method of measurement: Physical activity questionnaire metabolic equivalent Of task (MET). Shiraz University of Medical Sciences Shiraz university of medical sciences Shiraz university of medical sciences Approved 2018-02-05 Ethics Committee of Shiraz University of Medical Sciences Shiraz, Razi Blvd, Facing the Power Club, Faculty of Nutrition and Food Sciences Shiraz Fars Iran (Islamic Republic of)