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
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Intervention groups
#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. 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 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 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.
گروه مداخله: افراد گروه مداخله، 3 جلسه مشاوره حضوری فردی 20 دقیقه ای با پژوهشگر به صورت هفتگی خواهند داشت. در جلسه اول، ارزیابی تن سنجی، دریافت غذایی و فعالیت بدنی انجام می شود. همچنین در مورد نقش و اهمیت کنترل قند خون در T2DM توضیح و اهداف روش کربوهیدرات شماری ساده تبیین می شود. در جلسه دوم، رژیم غذایی که کالری آن بر اساس 25-35 کیلوکالری به ازای وزن بدن محاسبه شده است به افراد ارائه می شود. رژیم افراد با BMI پایین تر از ۲۵، ایزوکالریک بوده و از کالری رژیم افراد با BMI بالاتر از 25، 250 کیلوکالری کسر خواهد شد. درصد انرژی حاصل از درشت مغذی ها از کل کالری برای پروتیین بر حسب وضعیت پروتیینئوری، 15 تا 20 % خواهد بود. همچنین کربوهیدرات، 50 تا 55% و چربی ۳۰% خواهد بود. مقدار کربوهیدرات به صورت سهم های گروه های مختلف غذایی حاوی کربوهیدرات در 3 وعده اصلی و 3 میان وعده توزیع می شود. تعداد سهم ها همراه با ذکر مثال به بیمار ارائه شده و نحوه اجرای رژیم، اندازه سهم ها و مقدار کربوهیدراتشان توضیح داده می شود. در این جلسه بیماران با 7 گروه غذایی نان و غلات، قند های ساده، میوه ها، لبنیات، گوشت، سبزیجات و روغن ها آشنا خواهند شد و برگه لیست جانشینی مواد غذایی و توضیح نحوه اجرای آن را دریافت می کنند. جلسه سوم در مورد برچسب جدول ترکیبات غذایی محصولات غذایی بسته بندی شده و چگونگی محاسبه مقدار کربوهیدرات آن ها توضیح داده می شود. همچنین جلسه سوم شامل آشنایی با شاخص گلیسمیک غذا ها خواهد بود که توصیه های مربوطه و فهرست دسته بندی مواد غذایی از نظر شاخص گلیسمیک شان به افراد ارائه می شود. در هر جلسه مباحث جلسه قبل تثبیت و مشکلات رفع می شود. تا پایان مدت مداخله هر ماه یادآمد ۳ روزه خوراک به صورت تلفنی از شرکت کنندگان گرفته می شود. در مجموع 5 یادآمد 3 روزه خوراک با 15 روز بررسی از شرکت کنندگان اخذ خواهد شد. همچنین جهت اطمینان از رعایت آموزش ها و پاسخ به سوالات احتمالی هر هفته با افراد تماس گرفته شده، پیگیری و برای ادامه کار تشویق خواهند شد. مشاوره برای بیماران ناتوان و سالمند یا بدون توانایی خواندن، به فرد همراه ارائه می شود.
گروه مداخله: افراد گروه مداخله، 3 جلسه مشاوره حضوری فردی 20 دقیقه ای با پژوهشگر به صورت هفتگی خواهند داشت. در جلسه اول، ارزیابی تن سنجی، دریافت غذایی و فعالیت بدنی انجام می شود. همچنین در مورد نقش و اهمیت کنترل قند خون در T2DM توضیح و اهداف روش کربوهیدرات شماری ساده تبیین می شود. در جلسه دوم، رژیم غذایی که کالری آن بر اساس 25-35 کیلوکالری به ازای وزن بدن محاسبه شده است به افراد ارائه می شود. رژیم افراد با BMI پایین تر از ۲۵، ایزوکالریک بوده و از کالری رژیم افراد با BMI بالاتر از 25، 250 کیلوکالری کسر خواهد شد. برای افراد با BMI بالاتر از ۳۵ از وزن بدن ایده آل تعدیل یافته استفاده خواهد شد. ( وزن بدن ایده آل تعدیل یافته از اضافه کردن یک چهارم اضافه وزن به وزن ایده آل محاسبه می شود. وزن ایده آل با فرمول Hammwi محاسبه می شود.) درصد انرژی حاصل از درشت مغذی ها از کل کالری برای پروتیین بر حسب وضعیت پروتیینئوری، 15 تا 20 % خواهد بود. همچنین کربوهیدرات، 50 تا 55% و چربی ۳۰% خواهد بود. مقدار کربوهیدرات به صورت سهم های گروه های مختلف غذایی حاوی کربوهیدرات در 3 وعده اصلی و 3 میان وعده توزیع می شود. تعداد سهم ها همراه با ذکر مثال به بیمار ارائه شده و نحوه اجرای رژیم، اندازه سهم ها و مقدار کربوهیدراتشان توضیح داده می شود. در این جلسه بیماران با 7 گروه غذایی نان و غلات، قند های ساده، میوه ها، لبنیات، گوشت، سبزیجات و روغن ها آشنا خواهند شد و برگه لیست جانشینی مواد غذایی و توضیح نحوه اجرای آن را دریافت می کنند. جلسه سوم در مورد برچسب جدول ترکیبات غذایی محصولات غذایی بسته بندی شده و چگونگی محاسبه مقدار کربوهیدرات آن ها توضیح داده می شود. همچنین جلسه سوم شامل آشنایی با شاخص گلیسمیک غذا ها خواهد بود که توصیه های مربوطه و فهرست دسته بندی مواد غذایی از نظر شاخص گلیسمیک شان به افراد ارائه می شود. در هر جلسه مباحث جلسه قبل تثبیت و مشکلات رفع می شود. تا پایان مدت مداخله هر ماه یادآمد ۳ روزه خوراک به صورت تلفنی از شرکت کنندگان گرفته می شود. در مجموع 5 یادآمد 3 روزه خوراک با 15 روز بررسی از شرکت کنندگان اخذ خواهد شد. همچنین جهت اطمینان از رعایت آموزش ها و پاسخ به سوالات احتمالی هر هفته با افراد تماس گرفته شده، پیگیری و برای ادامه کار تشویق خواهند شد. مشاوره برای بیماران ناتوان و سالمند یا بدون توانایی خواندن، به فرد همراه ارائه می شود.
گروه مداخله: افراد گروه مداخله، 3 جلسه مشاوره حضوری فردی 20 دقیقه ای با پژوهشگر به صورت هفتگی خواهند داشت. در جلسه اول، ارزیابی تن سنجی، دریافت غذایی و فعالیت بدنی انجام می شود. همچنین در مورد نقش و اهمیت کنترل قند خون در T2DM توضیح و اهداف روش کربوهیدرات شماری ساده تبیین می شود. در جلسه دوم، رژیم غذایی که کالری آن بر اساس 25-35 کیلوکالری به ازای وزن بدن محاسبه شده است به افراد ارائه می شود. رژیم افراد با BMI پایین تر از ۲۵، ایزوکالریک بوده و از کالری رژیم افراد با BMI بالاتر از 25، 250 کیلوکالری کسر خواهد شد. برای افراد با BMI بالاتر از ۳۵ از وزن بدن ایده آل تعدیل یافته استفاده خواهد شد. ( وزن بدن ایده آل تعدیل یافته از اضافه کردن یک چهارم اضافه وزن به وزن ایده آل محاسبه می شود. وزن ایده آل با فرمول Hammwi محاسبه می شود.) درصد انرژی حاصل از درشت مغذی ها از کل کالری برای پروتیین بر حسب وضعیت پروتیینئوری، 15 تا 20 % خواهد بود. همچنین کربوهیدرات، 50 تا 55% و چربی ۳۰% خواهد بود. مقدار کربوهیدرات به صورت سهم های گروه های مختلف غذایی حاوی کربوهیدرات در 3 وعده اصلی و 3 میان وعده توزیع می شود. تعداد سهم ها همراه با ذکر مثال به بیمار ارائه شده و نحوه اجرای رژیم، اندازه سهم ها و مقدار کربوهیدراتشان توضیح داده می شود. در این جلسه بیماران با 7 گروه غذایی نان و غلات، قند های ساده، میوه ها، لبنیات، گوشت، سبزیجات و روغن ها آشنا خواهند شد و برگه لیست جانشینی مواد غذایی و توضیح نحوه اجرای آن را دریافت می کنند. جلسه سوم در مورد برچسب جدول ترکیبات غذایی محصولات غذایی بسته بندی شده و چگونگی محاسبه مقدار کربوهیدرات آن ها توضیح داده می شود. همچنین جلسه سوم شامل آشنایی با شاخص گلیسمیک غذا ها خواهد بود که توصیه های مربوطه و فهرست دسته بندی مواد غذایی از نظر شاخص گلیسمیک شان به افراد ارائه می شود. در هر جلسه مباحث جلسه قبل تثبیت و مشکلات رفع می شود. تا پایان مدت مداخله هر ماه یادآمد ۳ روزه خوراک به صورت تلفنی از شرکت کنندگان گرفته می شود. در مجموع 5 یادآمد 3 روزه خوراک با 15 روز بررسی از شرکت کنندگان اخذ خواهد شد. همچنین جهت اطمینان از رعایت آموزش ها و پاسخ به سوالات احتمالی هر هفته با افراد تماس گرفته شده، پیگیری و برای ادامه کار تشویق خواهند شد. مشاوره برای بیماران ناتوان و سالمند یا بدون توانایی خواندن، به فرد همراه ارائه می شود.
Protocol summary
Study aim
Determining the effect of nutritional counseling based on carbohydrate counting, glycemic profile and reducing energy consumption on glycemic, lipid, anthropometric and blood pressure control indicators of patients with T2DM referring to Urmia Imam Khomeini hospital and Tadbir clinic
Design
Randomized clinical trial before and after, with an intervention group and a control group on 94 patients
Settings and conduct
This study is a parallel randomized controlled clinical trial in the field of investigating the effect of nutritional counseling with the approach of carbohydrate counting, glycemic index and reducing energy consumption on glycemic, lipid, anthropometric and blood pressure indicators of type 2 diabetes patients referring to Imam Khomeini Hospital and Tadbir clinic in Urmia city has been designed. 94 patients will be randomly assigned to 2 intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Refer to Imam Khomeini hospital and Tadbir clinic in Urmia city; Having T2DM; No insulin injection; Exclusion criteria: pregnancy and breastfeeding; Gastroparesis; Following a special diet; Consumption of nutritional supplements in the last 3 months
Intervention groups
The control group will receive nutritional recommendations according to the nutritional training packagein the field of health by the researcher. People in the intervention group will have 3 face-to-face 20-minute counseling sessions with the researcher on a weekly basis. The sessions will include anthropometric assessment, food intake and physical activity, familiarization with the simple carbohydrate counting method, food groups and food classification in terms of glycemic index, and diet plan.
After the implementation of this project in August and September 1402 in the registered sampling center (Dizaj Siavosh Health Center, Urmia city), due to some problems and limitations, including the insufficient number of diabetic patients to the health center and the lack of the required sample size in the estimated period of time and the lack of cooperation and follow-up of patients with the health center, the implementation of the plan was stopped and the sampling center and the method of implementation of the plan were reviewed and edited again.
Acronym
IRCT registration information
IRCT registration number:IRCT20170206032417N7
Registration date:2023-07-24, 1402/05/02
Registration timing:prospective
Last update:2025-05-16, 1404/02/26
Update count:2
Registration date
2023-07-24, 1402/05/02
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3275 2375
Email address
alizadeh.m@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-05, 1402/10/15
Expected recruitment end date
2024-07-05, 1403/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the effect of carbohydrate counting counseling in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Pregnancy and breastfeeding
Gastroparesis
Following a special diet
Consumption of nutritional supplements in the last 3 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
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.
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
Research Ethics Committees of Urmia University of Medical Sciences
Street address
Resalat Blvd., emergency area, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2023-06-24, 1402/04/03
Ethics committee reference number
IR.UMSU.REC.1402.085
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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)
5
Description
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)
6
Description
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
7
Description
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
8
Description
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
9
Description
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
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tadbir specialized and sub-specialized clinic
Full name of responsible person
Laya Hooshmand Garehbagh
Street address
Amar street-Alley 13
City
Urmia
Province
West Azarbaijan
Postal code
571478373
Phone
+98 44 3346 2420
Email
laya.hooshmand@gmail.com
Web page address
https://tadbir.umsu.ac.ir/
2
Recruitment center
Name of recruitment center
Imam Khomeini educational-therapeutic center
Full name of responsible person
Laya Hooshmand Garehbagh
Street address
Ershad Ave-Modarres Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3345 9538
Fax
+98 44 3346 9935
Email
laya.hooshmand@gmail.com
Web page address
https://imam.umsu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Amin Valizadeh Hasanloui
Street address
Urmia, Resalat Blvd., Emergency valley, Headquarters of Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 4150
Email
aminvalizade@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
Professor of Nutritional Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Km 11 Nazlu Highway, Urmia University of Medical Sciences, Faculty of Medicine, Department of Nutrition
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3275 2375
Email
alizadeh.m@umsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
PhD in nutrition sciences/professor of Urmia University of Medical Sciences and faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Km 11 Nazlu Highway, Urmia University of Medical Sciences, Faculty of Medicine, Department of Nutrition
City
Urmia
Province
West Azarbaijan
Postal code
5315799313
Phone
+98 44 3275 2375
Email
alizadeh.m@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Fatemeh Pirmaddah saravani
Position
Master student of nutrition science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Km 11 Nazlu Highway, Urmia University of Medical Sciences, Faculty of Medicine, Department of Nutrition
City
Urmia
Province
West Azarbaijan
Postal code
5715799313
Phone
+98 44 3257 2357
Email
pirmaddah.f@umsu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available