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IRCT20170206032417N7 IRCT 2023-07-24 Oroumia University of Medical Sciences Investigating the effect of carbohydrate counting counseling in type 2 diabetes Investigating the effect of nutrition counseling based on carbohydrate counting, glycemic index and reducing energy consumption on glycemic, lipidemic, anthropometric control indicators, and blood pressure in patients with type 2 diabetes 2024-01-05 anticipated 94 Complete https://irct.ir/trial/71423 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of the samples using the Stratified Block Randomization by random allocation method based on the two variables of age and gender (use of card number 1 and also card number 2 according to the number of patients present in the study and random selection of cards) into two intervention groups and Control will be divided. N/A Type 2 diabetes mellitus. Intervention 1: Intervention group: People in the intervention group will have 3 face-to-face 20-minute counseling sessions with the researcher on a weekly basis. In the first session, anthropometry, food intake and physical activity are evaluated. Also, the role and importance of blood sugar control in T2DM is explained and the goals of the simple carbohydrate counting method are explained. In the second session, the diet, whose calories are calculated based on 25-35 kcal per body weight, is presented to the people. The diet of people with a BMI lower than 25 is isocaloric, and 250 kilocalories will be deducted from the calories of the diet of people with a BMI higher than 25. For people with a BMI above 35, the adjusted ideal body weight will be used. (Adjusted ideal body weight is calculated by adding one-fourth of the excess weight to the ideal weight. Ideal weight is calculated using the Hammwi formula.) The percentage of energy from macronutrients will be 15 to 20% of total calories for protein, depending on the protein status. Carbohydrates will be 50-55% and fat 30%. The amount of carbohydrates is distributed in the form of shares of different food groups containing carbohydrates in 3 main meals and 3 snacks. The number of portions is given to the patient along with examples, and the method of implementing the diet, the size of the portions, and the amount of carbohydrates are explained. In this session, patients will get to know the 7 food groups of bread and grains, simple sugars, fruits, dairy, meat, vegetables and oils, and they will receive a list of food substitutions and an explanation of how to implement it. The third session explains about the nutritional composition table label of packaged food products and how to calculate their carbohydrate content. Also, the third session will include familiarization with the glycemic index of foods, which will be presented to people with relevant recommendations and a list of categories of foods according to their glycemic index. In each meeting, the topics of the previous meeting are fixed and problems are solved. Until the end of the intervention period, a 3-day food recall will be taken from the participants by phone every month. A total of 5 food recall for 3 days with 15 days of review will be collected from the participants. Also, in order to ensure compliance with the training and answer possible questions, people will be contacted every week, followed up and encouraged to continue working. Counseling for disabled and elderly patients or those unable to read is provided to the accompanying person. Intervention 2: Control group: People in the control group will receive a sheet of nutritional recommendations for diabetics according to the nutrition training package in the health transformation program in the field of health, by the researcher, which is a 15-minute counseling session. Until the end of the study period, a 3-day food recall (15 reminders in total) will be collected from the control group every month. 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 There is no further information
public Dr. Mohammad Alizadeh
Km 11 Nazlu Highway, Urmia University of Medical Sciences, Faculty of Medicine, Department of Nutrition
Urmia Iran (Islamic Republic of) 5715799313 +98 44 3275 2375 alizadeh.m@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Mohammad Alizadeh
Km 11 Nazlu Highway, Urmia University of Medical Sciences, Faculty of Medicine, Department of Nutrition
Urmia Iran (Islamic Republic of) 5315799313 +98 44 3275 2375 alizadeh.m@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Refer to Imam khomeini educational-therapeutic center and Tadbir clinic in Urmia city Having T2DM based on a physician's diagnosis and FPG criteria equal to and greater than 126 mg/dL and HbA1C equal to and greater than 6.5% Age above 18 years No insulin injection 18 years no limit Both Pregnancy and breastfeeding Gastroparesis Following a special diet Consumption of nutritional supplements in the last 3 months E11 Type 2 diabetes mellitus Treatment - Other Treatment - Other Intervention group: People in the intervention group will have 3 face-to-face 20-minute counseling sessions with the researcher on a weekly basis. In the first session, anthropometry, food intake and physical activity are evaluated. Also, the role and importance of blood sugar control in T2DM is explained and the goals of the simple carbohydrate counting method are explained. In the second session, the diet, whose calories are calculated based on 25-35 kcal per body weight, is presented to the people. The diet of people with a BMI lower than 25 is isocaloric, and 250 kilocalories will be deducted from the calories of the diet of people with a BMI higher than 25. For people with a BMI above 35, the adjusted ideal body weight will be used. (Adjusted ideal body weight is calculated by adding one-fourth of the excess weight to the ideal weight. Ideal weight is calculated using the Hammwi formula.) The percentage of energy from macronutrients will be 15 to 20% of total calories for protein, depending on the protein status. Carbohydrates will be 50-55% and fat 30%. The amount of carbohydrates is distributed in the form of shares of different food groups containing carbohydrates in 3 main meals and 3 snacks. The number of portions is given to the patient along with examples, and the method of implementing the diet, the size of the portions, and the amount of carbohydrates are explained. In this session, patients will get to know the 7 food groups of bread and grains, simple sugars, fruits, dairy, meat, vegetables and oils, and they will receive a list of food substitutions and an explanation of how to implement it. The third session explains about the nutritional composition table label of packaged food products and how to calculate their carbohydrate content. Also, the third session will include familiarization with the glycemic index of foods, which will be presented to people with relevant recommendations and a list of categories of foods according to their glycemic index. In each meeting, the topics of the previous meeting are fixed and problems are solved. Until the end of the intervention period, a 3-day food recall will be taken from the participants by phone every month. A total of 5 food recall for 3 days with 15 days of review will be collected from the participants. Also, in order to ensure compliance with the training and answer possible questions, people will be contacted every week, followed up and encouraged to continue working. Counseling for disabled and elderly patients or those unable to read is provided to the accompanying person. Control group: People in the control group will receive a sheet of nutritional recommendations for diabetics according to the nutrition training package in the health transformation program in the field of health, by the researcher, which is a 15-minute counseling session. Until the end of the study period, a 3-day food recall (15 reminders in total) will be collected from the control group every month. Fasting blood sugar. Timepoint: Fasting blood sugar measurement at the beginning of the study (before the start of the intervention) and 16 week of the study (12 weeks after the end of the counseling sessions of the intervention group). Method of measurement: Enzymatic method - international unit per liter. Glycosylated hemoglobin A1c. Timepoint: Measurement of glycosylated hemoglobin A1c at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group). Method of measurement: Enzymatic method - milligrams per deciliter. Waist circumference. Timepoint: Measurement of waist circumference at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group). Method of measurement: Tape meters-centimeters. Systolic blood pressure. Timepoint: Measurement of systolic blood pressure at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group). Method of measurement: Digital sphygmomanometer - millimeters of mercury(mmHg). Diastolic blood pressure. Timepoint: Measurement of diastolic blood pressure at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group). Method of measurement: Digital sphygmomanometer - millimeters of mercury(mmHg). Triglyceride. Timepoint: Measurement of triglyceride at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the end of the counseling sessions of the intervention group). Method of measurement: Enzymatic method - milligrams per deciliter. LDL-cholesterol. Timepoint: Measurement of LDL-cholesterol at the beginning of the study (before the start of the intervention) and week 16 of the study (12 weeks after the completion of the counseling sessions of the intervention group). Method of measurement: Enzymatic method - milligrams per deciliter. HDL-cholesterol. Timepoint: HDL-cholesterol measurement at the beginning of the study (before the start of the intervention) and the 16th week of the study (12 weeks after the end of the counseling sessions of the intervention group). Method of measurement: Enzymatic method - milligrams per deciliter. 2 hour post prandial glucose. Timepoint: 2 hour post prandial glucose measurement at the beginning of the study (before the start of the intervention) and the 16th week of the study (12 weeks after the end of the counseling sessions of the intervention group). Method of measurement: Enzymatic method - milligrams per deciliter. Weight. Timepoint: Weight measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after the end of the counseling sessions of the intervention group). Method of measurement: Scale-kilogram. Total cholesterol. Timepoint: Total cholesterol measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after. Method of measurement: Enzymatic method - milligrams per deciliter. Body mass index. Timepoint: Body mass index measurement at the beginning of the study (before the start of the intervention) and week 16 (12 weeks after. Method of measurement: Weight/ height squared. Oroumia University of Medical Sciences Approved 2023-06-24 Research Ethics Committees of Urmia University of Medical Sciences Resalat Blvd., emergency area, Urmia University of Medical Sciences Urmia West Azarbaijan Iran (Islamic Republic of)