Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Omidiyeh.
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Protocol summary
Samples were randomly divided into intervention and control groups.Each group has 40 people.
Samples with block randomization were randomly divided into intervention and control groups. Each group has 45people.
Samples with block randomization were randomly divided into intervention and control groups.Eachgroups. Each group has 40 people45people.
نمونه ها به صورت تصادفی ساده به دو گروه مداخله و کنترل تقسیم می شوند.در هر گروه 40 نفر قرار دارد.
نمونه ها به صورت تصادفی سازی بلوکی به دو گروه مداخله و کنترل تقسیم می شوند.در هر گروه 45 نفر قرار دارد.
نمونه ها به صورت تصادفی سادهسازی بلوکی به دو گروه مداخله و کنترل تقسیم می شوند.در هر گروه 4045 نفر قرار دارد.
This is a semi-experimental interventional study that will be carried out among pregnant women covered by Ahvaz health care centers.
This is an open label controlled -randomized interventional trial that will be carried out among pregnant women covered by Omidiyeh health care centers.
This is a semian open label controlled -experimentalrandomized interventional studytrial that will be carried out among pregnant women covered by AhvazOmidiyeh health care centers.
این مطالعه یک پژوهش مداخله ایی از نوع نیمه تجربی است که در بین زنان باردار تحت پوشش مراکز بهداشتی و درمانی شهر اهواز صورت خواهد گرفت .
ااین یک کارآزمایی مداخله ای تصادفی-کنترل شده است که بر روی زنان باردار تحت پوشش مراکز بهداشتی درمانی امیدیه انجام خواهد شد.
این مطالعهااین یک پژوهشکارآزمایی مداخله ایی از نوع نیمه تجربیای تصادفی-کنترل شده است که در بینبر روی زنان باردار تحت پوشش مراکز بهداشتی و درمانی شهر اهواز صورتامیدیه انجام خواهد گرفت شد.
Inclusion criteria: 12 to 16 weeks pregnancy, single-crowned pregnancy, having BMI greater than 25 or overweight BMI greater than 30, age over 25 years, having a family history of type 2 diabetes in first-degree relatives, having a history of gestational diabetes or glucose intolerance in the previous pregnancy, having a baby weighing more than 4000 grams, having a premature baby, or losing a baby during the previous pregnancy, and exit criteria: having type 2 diabetes, thyroid disease, cardiovascular disease, respiratory disease, history of taking medications that affect The level of blood sugar like corticosteroids
Inclusion criteria: 12 to 16 weeks pregnancy, single-crowned pregnancy, having BMI> 25 or overweight, BMI > 30, age ≥ 25 years, having a family history of type 2 diabetes in first-degree relatives, having a history of GDM or glucose intolerance in her previous pregnancy, having a baby weighing >4000 gr, having a premature baby, or losing a baby during her previous pregnancy .exclusion criteria: having type 2 diabetes, thyroid disease, cardiovascular disease, respiratory disease, history of taking medications that affect the level of blood sugar like corticosteroids
Inclusion criteria: 12 to 16 weeks pregnancy, single-crowned pregnancy, having BMI greater than> 25 or overweight, BMI greater than> 30, age over≥ 25 years, having a family history of type 2 diabetes in first-degree relatives, having a history of gestational diabetesGDM or glucose intolerance in theher previous pregnancy, having a baby weighing more than >4000 gramsgr, having a premature baby, or losing a baby during theher previous pregnancy, and exit .exclusion criteria: having type 2 diabetes, thyroid disease, cardiovascular disease, respiratory disease, history of taking medications that affect Thethe level of blood sugar like corticosteroids
معیارهای ورود : سن بارداری 12تا16 هفته ، بارداری تک قلویی ، داشتن افزایش وزن BMI بالاتر از 25 یا چاقی BMI بالاتر 30 ، سن بیش از 25 سال ، داشتن تاریخچه خانوادگی دیابت نوع 2 در بستگان درجه اول ، داشتن تاریخچه دیابت بارداری یا عدم تحمل گلوگز در بارداری قبلی ، داشتن نوزاد با وزن بیشتر 4000 گرم ، داشتن نوزاد نارس یا از دست دادن نوزاد در در بارداری قبلی و معیارهای خروج : داشتن دیابت اشکار نوع دو ، بیماری تیروئید ، بیماری قلبی عروقی ، بیماری تنفسی ، داشتن تاریخچه مصرف داروهایی که بر سطح قند خون تاثیر دارد مانند داروهای کورتیکواسترویید
معیارهای ورود : سن بارداری 12تا16 هفته ، بارداری تک قلویی ، داشتن BMIاضافه وزن بالاتر از 25 یا چاقی BMI بالاتر 30 ، سن ≥ 25 سال ، داشتن تاریخچه خانوادگی دیابت نوع 2 در بستگان درجه اول ، داشتن تاریخچه دیابت بارداری یا عدم تحمل گلوگز در بارداری قبلی ، داشتن نوزاد با وزن بیشتر 4000 گرم ، داشتن نوزاد نارس یا از دست دادن نوزاد در در بارداری قبلی و معیارهای خروج : داشتن دیابت اشکار نوع دو ، بیماری تیروئید ، بیماری قلبی عروقی ، بیماری تنفسی ، داشتن تاریخچه مصرف داروهایی که بر سطح قند خون تاثیر دارد مانند داروهای کورتیکواسترویید
معیارهای ورود : سن بارداری 12تا16 هفته ، بارداری تک قلویی ، داشتن افزایشBMIاضافه وزن BMI بالاتر از 25 یا چاقی BMI بالاتر 30 ، سن بیش از≥ 25 سال ، داشتن تاریخچه خانوادگی دیابت نوع 2 در بستگان درجه اول ، داشتن تاریخچه دیابت بارداری یا عدم تحمل گلوگز در بارداری قبلی ، داشتن نوزاد با وزن بیشتر 4000 گرم ، داشتن نوزاد نارس یا از دست دادن نوزاد در در بارداری قبلی و معیارهای خروج : داشتن دیابت اشکار نوع دو ، بیماری تیروئید ، بیماری قلبی عروقی ، بیماری تنفسی ، داشتن تاریخچه مصرف داروهایی که بر سطح قند خون تاثیر دارد مانند داروهای کورتیکواسترویید
Training on pregnant women in the intervention group is based on the glycemic index of food items and their glycemic load and their effect on the blood sugar of the pregnant mother. Pregnant women in the control group receive routine pregnancy training and care. The duration of the intervention is three months.
it is based on the glycemic index of food items and their glycemic load and their effect on the blood sugar of the pregnant mother. Pregnant women in the control group receive routine health care. The duration of the intervention is three months.
Training on pregnant women in the intervention groupit is based on the glycemic index of food items and their glycemic load and their effect on the blood sugar of the pregnant mother. Pregnant women in the control group receive routine pregnancy training andhealth care. The duration of the intervention is three months.
General information
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2020-09-01, 1399/06/11
2020-09-01 00:00:00
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2021-03-02, 1399/12/12
2021-03-02 00:00:00
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2022-04-30, 1401/02/10
2022-04-30 00:00:00
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- correction of maternal minimum age was 25 according to the inclusion criteria (by typo mistake had been written 18)
- BMI replaced with pre-BMI (due to pregnancy period)
-research place changed to Omidiyeh
- sample size increased to 90
-in the "Other design features" open-label, Parallel - controlled randomized trial has been addressed
-updating the actual date of enrolment and completion date
-add secondary outcomes including HOMA-IR and HOMA-IS
- complete the share plan section
- correction of maternal minimum age was 25 according to the inclusion criteria (by typo mistake had been written 18) - BMI replaced with pre-BMI (due to pregnancy period) -research place changed to Omidiyeh - sample size increased to 90 -in the "Other design features" open-label, Parallel - controlled randomized trial has been addressed -updating the actual date of enrolment and completion date -add secondary outcomes including HOMA-IR and HOMA-IS - complete the share plan section
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- تصحیح حداقل سن مادر 25 سال بر اساس معیارهای ورود (به اشتباه تایپی 18 نوشته شده بود)
- جایگزینی BMI با BMI قبل از بارداری (به دلیل دوره بارداری)
-محل پژوهش به شهر امیدیه تغییر یافت
حجم نمونه به 90 افزایش یافت
-در "سایر ویژگی های مطالعه "، کارآزمایی تصادفی کنترل شده موازی open-label مطرح شده است.
-اضافه کردن نتایج ثانویه از جملهHOMA-IR and HOMA-IS
-به روز رسانی تاریخ واقعی ثبت نام و تاریخ تکمیل
تکمیل بخش طرح اشتراک گذاری
- تصحیح حداقل سن مادر 25 سال بر اساس معیارهای ورود (به اشتباه تایپی 18 نوشته شده بود) - جایگزینی BMI با BMI قبل از بارداری (به دلیل دوره بارداری) -محل پژوهش به شهر امیدیه تغییر یافت حجم نمونه به 90 افزایش یافت -در "سایر ویژگی های مطالعه "، کارآزمایی تصادفی کنترل شده موازی open-label مطرح شده است. -اضافه کردن نتایج ثانویه از جملهHOMA-IR and HOMA-IS -به روز رسانی تاریخ واقعی ثبت نام و تاریخ تکمیل تکمیل بخش طرح اشتراک گذاری
Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Ahvaz.
Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Omidiyeh.
Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, AhvazOmidiyeh.
بررسی تاثیر مداخله اموزشی اقلام غذایی بر اساس شاخص گلایسمیک بر اساس مدل اعتقاد بهداشتی (HBM) بر تعیین ریسک بروز دیابت بارداری در زنان باردار مراجعه کننده به مراکز بهداشتی و درمانی شهر اهواز
بررسی تاثیر مداخله اموزشی اقلام غذایی بر اساس شاخص گلایسمیک بر اساس مدل اعتقاد بهداشتی (HBM) بر تعیین ریسک بروز دیابت بارداری در زنان باردار مراجعه کننده به مراکز بهداشتی و درمانی شهر امیدیه
بررسی تاثیر مداخله اموزشی اقلام غذایی بر اساس شاخص گلایسمیک بر اساس مدل اعتقاد بهداشتی (HBM) بر تعیین ریسک بروز دیابت بارداری در زنان باردار مراجعه کننده به مراکز بهداشتی و درمانی شهر اهوازامیدیه
Interested in participating in the study
Gestational age 12-16 weeks
Having reading and writing skills
Single pregnancy
Having weight gain, BMI> 25 or obesity, BMI> 30
Age over 25 years
Having a family history of type 2 diabetes in first-degree relatives
Having a history of gestational diabetes or glucose intolerance in previous pregnancies
Having a baby weighing> 4000 grams
Having a baby prematurely or losing a baby during the previous pregnancy
Interested in participating in the study
Gestational age 12-16 weeks
Having reading and writing skills
Single pregnancy
over weight pre-BMI> 25 or obese pre-BMI> 30
Age ≥ 25 years
Having a family history of type 2 diabetes in first-degree relatives
Having a history of gestational diabetes or glucose intolerance in previous pregnancies
Having a neonatal birth weight > 4000 grams
Having a baby prematurely or losing a baby during the previous pregnancy
Interested in participating in the study Gestational age 12-16 weeks Having reading and writing skills Single pregnancy Havingover weight gain, pre-BMI> 25 or obesity, obese pre-BMI> 30 Age over≥ 25 years Having a family history of type 2 diabetes in first-degree relatives Having a history of gestational diabetes or glucose intolerance in previous pregnancies Having a baby weighingneonatal birth weight > 4000 grams Having a baby prematurely or losing a baby during the previous pregnancy
1. علاقمند به شرکت در مطالعه
2. سن بارداری 12-16 هفته
3. داشتن سواد خواندن و نوشتن
4. بارداری تک قلویی
5. داشتن افزایش وزن BMI> 25 یا چاقی BMI> 30
6. سن بیش از 25 سال
7. داشتن تاریخچه خانوادگی دیابت نوع 2 در بستگان درجه اول
8. داشتن تاریخچه دیابت بارداری یا عدم تحمل گلوگز در بارداری قبلی
9. داشتن نوزاد با وزن > 4000 گرم
10. داشتن نوزاد نارس یا از دست دادن نوزاد در در بارداری قبلی
1. علاقمند به شرکت در مطالعه
2. سن بارداری 12-16 هفته
3. داشتن سواد خواندن و نوشتن
4. بارداری تک قلویی
5. شاخص توده بدنی اضافه وزن pre-BMI> 25 یا چاقی pre-BMI> 30
6. سن ≥ 25 سال
7. داشتن تاریخچه خانوادگی دیابت نوع 2 در بستگان درجه اول
8. داشتن تاریخچه دیابت بارداری یا عدم تحمل گلوگز در بارداری قبلی
9. داشتن نوزاد با وزن > 4000 گرم
10. داشتن نوزاد نارس یا از دست دادن نوزاد در در بارداری قبلی
1. علاقمند به شرکت در مطالعه 2. سن بارداری 12-16 هفته 3. داشتن سواد خواندن و نوشتن 4. بارداری تک قلویی 5. داشتن افزایششاخص توده بدنی اضافه وزن pre-BMI> 25 یا چاقی pre-BMI> 30 6. سن بیش از≥ 25 سال 7. داشتن تاریخچه خانوادگی دیابت نوع 2 در بستگان درجه اول 8. داشتن تاریخچه دیابت بارداری یا عدم تحمل گلوگز در بارداری قبلی 9. داشتن نوزاد با وزن > 4000 گرم 10. داشتن نوزاد نارس یا از دست دادن نوزاد در در بارداری قبلی
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open label, Parallel - controlled randomized trial
open label, Parallel - controlled randomized trial
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کارآزمایی تصادفی کنترل شده موازی(open label)
کارآزمایی تصادفی کنترل شده موازی(open label)
In a randomized simple way, two groups of intervention and control (using random numbers table)
using block randomization , two groups of intervention and control (using random numbers table)
In a randomized simple wayusing block randomization , two groups of intervention and control (using random numbers table)
به صورت تصادفی ساده در دو گروه مداخله و کنترل(استفاده از جدول اعداد تصادفی )
با استفاده از تصادفی سازی بلوکی در دو گروه مداخله و کنترل(استفاده از جدول اعداد تصادفی )
به صورتبا استفاده از تصادفی سادهسازی بلوکی در دو گروه مداخله و کنترل(استفاده از جدول اعداد تصادفی )
Primary outcomes
#1
Blood tests and fasting blood glucose measurements
Serum sample
Blood tests and fasting blood glucose measurementsSerum sample
آزمایش خون و اندازه گیری قند خون ناشتا
نمونه سرم
آزمایش خون و اندازه گیری قند خون ناشتانمونه سرم
#2
Using OGTT
Serum sample
Using OGTTSerum sample
انجام OGTT
نمونه سرم
انجام OGTTنمونه سرم
#3
Blood test and INS measurement
Serum sample
Blood test and INS measurementSerum sample
آزمایش خون و اندازه گیری INS
نمونه سرم
آزمایش خون و اندازه گیری INSنمونه سرم
#4
Blood test and hs CRP measurement
Serum sample
Blood test and hs CRP measurementSerum sample
آزمایش خون و اندازه گیری hs CRP
نمونه سرم
آزمایش خون و اندازه گیری hs CRPنمونه سرم
Secondary outcomes
#1
Weight ratio (kg) divided by height (m) to power two
weight in kilograms (kg) by their height in meters (m) squared
Weight ratioweight in kilograms (kg) divided by their height in meters (m) to power twosquared
#2
Blood test and TG measurement
Serum sample
Blood test and TG measurementSerum sample
آزمایش خون و اندازه گیری TG
نمونه سرم
آزمایش خون و اندازه گیری TGنمونه سرم
#3
Perform blood tests and measure TC
Serum sample
Perform blood tests and measure TCSerum sample
انجام آزمایش خون و اندازه گیری TC
نمونه سرم
انجام آزمایش خون و اندازه گیری TCنمونه سرم
#4
Blood test and LDL and HDL measurements
Serum sample
Blood test and LDL and HDL measurementsSerum sample
آزمایش خون و اندازه گیری LDL و HDL
نمونه سرم
آزمایش خون و اندازه گیری LDL و HDLنمونه سرم
#5
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Insulin Sensitivity
Insulin Sensitivity
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حساسیت به انسولین
حساسیت به انسولین
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Before the intervention and three months after the intervention
Before the intervention and three months after the intervention
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قبل از مداخله و سه ماه بعد از مداخله
قبل از مداخله و سه ماه بعد از مداخله
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Formula based
Formula based
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بر اساس فرمول
بر اساس فرمول
#6
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Insulin resistance
Insulin resistance
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مقاومت به انسولین
مقاومت به انسولین
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Before the intervention and three months after the intervention
Before the intervention and three months after the intervention
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قبل از مداخله و سه ماه بعد از مداخله
قبل از مداخله و سه ماه بعد از مداخله
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Formula based
Formula based
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بر اساس فرمول
بر اساس فرمول
Intervention groups
#1
Intervention group: A general questionnaire and a physical activity questionnaire, a three-day dietary questionnaire for food intake and a researcher-made questionnaire based on the HBM model that included awareness, autoimmunity, sensitivity and severity, and the perceived benefits and barriers in choosing action. Nutritional behaviors preventing gestational diabetes mellitus from the population studied before the start of the training session. The training is based on the glycemic index of food items and their glycemic load and its effect on the pregnant mother's blood glucose, the prevalence of gestational diabetes mellitus and its complications for mother and fetus, and the importance of preventing gestational diabetes. At the end of the three-month intervention period, a face-to-face session for the post-test, the Health Belief Model (HBM) questionnaire and the three-day food registration form will be re-launched.
Intervention group: A general questionnaire and a physical activity questionnaire, a three-days food record and a researcher-made questionnaire based on the HBM model with subscales of; awareness, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy and guidance for action before and after three-months will be collected .The education sessions is based on the dietary glycemic index of food items and their glycemic load and its effect on the maternal blood glucose, prevalence of gestational diabetes mellitus and its complications for mother and fetus, and prevention of gestational diabetes. At the end of the three-months intervention period, a face-to-face session, the HBM questionnaire, three-day food record and physical activity questionnaire will be collected.
Intervention group: A general questionnaire and a physical activity questionnaire, a three-day dietary questionnaire fordays food intakerecord and a researcher-made questionnaire based on the HBM model that includedwith subscales of; awareness, autoimmunityperceived susceptibility, sensitivity andperceived severity, and theperceived benefits, perceived benefitsbarriers, self-efficacy and barriers in choosingguidance for action. Nutritional behaviors preventing gestational diabetes mellitus from the population studied before the start of the training sessionand after three-months will be collected .The trainingeducation sessions is based on the dietary glycemic index of food items and their glycemic load and its effect on the pregnant mother'smaternal blood glucose, the prevalence of gestational diabetes mellitus and its complications for mother and fetus, and the importanceprevention of preventing gestational diabetes. At the end of the three-monthmonths intervention period, a face-to-face session for the post-test, the Health Belief Model (HBM) questionnaire and the, three-day food registration formrecord and physical activity questionnaire will be re-launchedcollected.
گروه مداخله: پرسشنامه عمومی و پرسشنامه فعالیت فیزیکی و فرم ثبت سه روزه غذا جهت کسب اطلاعات دریافت غذایی و پرسشنامه محقق ساخته بر اساس مدل اعتقاد بهداشتی (HBM) که شامل بخش های اگاهی ، خودکارامدی ، حساسیت و شدت و منافع و موانع درک شده در انتخاب عمل و رفتارهای تغذیه ایی پیشگیری کننده از بروز دیابت بارداری ، از جمعیت مورد مطالعه قبل از شروع جلسه مداخله اموزشی گرداوری میشود . اموزش بر اساس شاخص گلیسمیک اقلام غذایی و بار گلیسمیک انها و تاثیر ان بر قند خون مادر باردار ، بیان شیوع دیابت بارداری و عوارض حاصل از ان برای مادر و جنین و اهمیت پیشگیری از بروز دیابت بارداری صورت میگیرد . در پایان دوره سه ماهه مداخله اموزشی ، جلسه حضوری جهت پس آزمون، پرسشنامه سنجش مدل اعتقاد بهداشتی(HBM) و فرم ثبت سه روزه غذا دوباره انجام خواهد شد .
گروه مداخله: پرسشنامه عمومی و پرسشنامه فعالیت فیزیکی و فرم ثبت سه روزه غذا جهت کسب اطلاعات دریافت غذایی و پرسشنامه محقق ساخته بر اساس مدل اعتقاد بهداشتی (HBM) که شامل بخش های اگاهی ، خودکارامدی ، حساسیت و شدت و منافع و موانع درک شده در انتخاب عمل و رفتارهای تغذیه ایی پیشگیری کننده از بروز دیابت بارداری ، از جمعیت مورد مطالعه قبل از شروع جلسه مداخله اموزشی گرداوری میشود . اموزش بر اساس شاخص گلیسمیک اقلام غذایی و بار گلیسمیک انها و تاثیر ان بر قند خون مادر باردار ، بیان شیوع دیابت بارداری و عوارض حاصل از ان برای مادر و جنین و اهمیت پیشگیری از بروز دیابت بارداری صورت میگیرد . در پایان دوره سه ماهه مداخله اموزشی ، جلسه حضوری جهت گرداوری پرسشنامه مدل اعتقاد بهداشتی(HBM) پرسشنامه فعالیت فیزیکی، و فرم ثبت سه روزه غذا دوباره انجام خواهد شد .
گروه مداخله: پرسشنامه عمومی و پرسشنامه فعالیت فیزیکی و فرم ثبت سه روزه غذا جهت کسب اطلاعات دریافت غذایی و پرسشنامه محقق ساخته بر اساس مدل اعتقاد بهداشتی (HBM) که شامل بخش های اگاهی ، خودکارامدی ، حساسیت و شدت و منافع و موانع درک شده در انتخاب عمل و رفتارهای تغذیه ایی پیشگیری کننده از بروز دیابت بارداری ، از جمعیت مورد مطالعه قبل از شروع جلسه مداخله اموزشی گرداوری میشود . اموزش بر اساس شاخص گلیسمیک اقلام غذایی و بار گلیسمیک انها و تاثیر ان بر قند خون مادر باردار ، بیان شیوع دیابت بارداری و عوارض حاصل از ان برای مادر و جنین و اهمیت پیشگیری از بروز دیابت بارداری صورت میگیرد . در پایان دوره سه ماهه مداخله اموزشی ، جلسه حضوری جهت پس آزمون،گرداوری پرسشنامه سنجش مدل اعتقاد بهداشتی(HBM) پرسشنامه فعالیت فیزیکی، و فرم ثبت سه روزه غذا دوباره انجام خواهد شد .
Recruitment centers
#1
Name of recruitment center - English: Health Services Centers
Name of recruitment center - Persian: مراکز خدمات جامع سلامت شهری
Full name of responsible person - English: Shirin alipour
Full name of responsible person - Persian: شیرین علیپور
Street address - English: Health Services Centers
Street address - Persian: مراکز خدمات جامع سلامت شهری
City - English: Ahvaz
City - Persian: اهواز
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3333 3477
Fax:
Email: alipour.sh@ajums.ac.ir
Web page address:
Name of recruitment center - English: public Health care Centers
Name of recruitment center - Persian: مراکز خدمات جامع سلامت شهری
Full name of responsible person - English: Shirin Alipour
Full name of responsible person - Persian: شیرین علیپور
Street address - English: public Health care Centers
Street address - Persian: مراکز خدمات جامع سلامت شهری
City - English: Omidiyeh
City - Persian: امیدیه
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6135715794
Phone: +98 61 3333 3477
Fax:
Email: alipour.sh@ajums.ac.ir
Web page address:
Name of recruitment center - English: public Health Servicescare Centers Name of recruitment center - Persian: مراکز خدمات جامع سلامت شهری Full name of responsible person - English: Shirin alipourAlipour Full name of responsible person - Persian: شیرین علیپور Street address - English: public Health Servicescare Centers Street address - Persian: مراکز خدمات جامع سلامت شهری City - English: AhvazOmidiyeh City - Persian: اهوازامیدیه Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6135715794 Phone: +98 61 3333 3477 Fax: Email: alipour.sh@ajums.ac.ir Web page address:
Sharing plan
undecided
yes
undecidedyes
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Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Omidiyeh.
Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Omidiyeh.
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بررسی تاثیر آموزش تغذیه بر شاخص گلیسمی بر اساس مدل اعتقاد بهداشتی (HBM) بر تعیین خطر ابتلا به دیابت بارداری در مادران باردار مراجعه کننده به مرکز بهداشت امیدیه.
بررسی تاثیر آموزش تغذیه بر شاخص گلیسمی بر اساس مدل اعتقاد بهداشتی (HBM) بر تعیین خطر ابتلا به دیابت بارداری در مادران باردار مراجعه کننده به مرکز بهداشت امیدیه.
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After the publication of the article
After the publication of the article
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پس از انتشار مقاله
پس از انتشار مقاله
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All
All
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همه
همه
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study
study
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مطالعه
مطالعه
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Fatemeh Borazjani
Fatemeh Borazjani
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فاطمه برازجانی
فاطمه برازجانی
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E mail
E mail
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پست الکترونیک
پست الکترونیک
Protocol summary
Study aim
The purpose of this study is to investigate the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant women
Design
Samples with block randomization were randomly divided into intervention and control groups. Each group has 45people.
Settings and conduct
This is an open label controlled -randomized interventional trial that will be carried out among pregnant women covered by Omidiyeh health care centers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 12 to 16 weeks pregnancy, single-crowned pregnancy, having BMI> 25 or overweight, BMI > 30, age ≥ 25 years, having a family history of type 2 diabetes in first-degree relatives, having a history of GDM or glucose intolerance in her previous pregnancy, having a baby weighing >4000 gr, having a premature baby, or losing a baby during her previous pregnancy .exclusion criteria: having type 2 diabetes, thyroid disease, cardiovascular disease, respiratory disease, history of taking medications that affect the level of blood sugar like corticosteroids
Intervention groups
it is based on the glycemic index of food items and their glycemic load and their effect on the blood sugar of the pregnant mother. Pregnant women in the control group receive routine health care. The duration of the intervention is three months.
Main outcome variables
At the beginning and the end of the study will be measured fasting blood glucose, blood glucose 1h ppt and 2h ppt after giving 75 grams of oral glucose, Fasting insulin, hs CRP, total cholesterol, LDL and HDL cholesterol, triglycerides, and the variables of the health belief model.
General information
Reason for update
- correction of maternal minimum age was 25 according to the inclusion criteria (by typo mistake had been written 18)
- BMI replaced with pre-BMI (due to pregnancy period)
-research place changed to Omidiyeh
- sample size increased to 90
-in the "Other design features" open-label, Parallel - controlled randomized trial has been addressed
-updating the actual date of enrolment and completion date
-add secondary outcomes including HOMA-IR and HOMA-IS
- complete the share plan section
Acronym
IRCT registration information
IRCT registration number:IRCT20190227042858N1
Registration date:2019-07-18, 1398/04/27
Registration timing:prospective
Last update:2023-08-23, 1402/06/01
Update count:1
Registration date
2019-07-18, 1398/04/27
Registrant information
Name
Shirin Alipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 6756
Email address
alipour.sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2019-11-06, 1398/08/15
Actual recruitment start date
2020-09-01, 1399/06/11
Actual recruitment end date
2021-03-02, 1399/12/12
Trial completion date
2022-04-30, 1401/02/10
Scientific title
Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Omidiyeh.
Public title
The effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Interested in participating in the study
Gestational age 12-16 weeks
Having reading and writing skills
Single pregnancy
over weight pre-BMI> 25 or obese pre-BMI> 30
Age ≥ 25 years
Having a family history of type 2 diabetes in first-degree relatives
Having a history of gestational diabetes or glucose intolerance in previous pregnancies
Having a neonatal birth weight > 4000 grams
Having a baby prematurely or losing a baby during the previous pregnancy
Exclusion criteria:
Having Type 2 Diabetes / Thyroid Disease / Cardiovascular Disease / Respiratory Disease
Having a history of taking drugs that affect blood sugar level, such as corticosteroid medications
Absence of active participation in class / training sessions
Age
From 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
using block randomization , two groups of intervention and control (using random numbers table)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
open label, Parallel - controlled randomized trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Highway, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-11-10, 1397/08/19
Ethics committee reference number
IR.AJUMS.REC.1397.600
Health conditions studied
1
Description of health condition studied
Gestational Diabetes
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy
Primary outcomes
1
Description
Fasting blood glucose
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Serum sample
2
Description
Blood Glucose Level One hour, two hours after giving 75 grams of glucose
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Serum sample
3
Description
Fasting Insulin serum
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Serum sample
4
Description
hs CRP measurement
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Serum sample
5
Description
Health belief model variables (awareness, sensitivity, severity, perceived benefits and barriers and self-efficacy)
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Health Belief Model Questionnaire
Secondary outcomes
1
Description
Body Mass Index (BMI) measurements
Timepoint
Before intervention and three months after the intervention
Method of measurement
weight in kilograms (kg) by their height in meters (m) squared
2
Description
Measuring maternal weight gain
Timepoint
Before intervention and three months after the intervention
Method of measurement
digital scale
3
Description
Measure physical activity
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Physical activity questionnaire
4
Description
Measurement of triglyceride levels
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Serum sample
5
Description
Total cholesterol level measurements
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Serum sample
6
Description
Measuring LDL and HDL cholesterol
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Serum sample
7
Description
Insulin Sensitivity
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Formula based
8
Description
Insulin resistance
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Formula based
Intervention groups
1
Description
Intervention group: A general questionnaire and a physical activity questionnaire, a three-days food record and a researcher-made questionnaire based on the HBM model with subscales of; awareness, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy and guidance for action before and after three-months will be collected .The education sessions is based on the dietary glycemic index of food items and their glycemic load and its effect on the maternal blood glucose, prevalence of gestational diabetes mellitus and its complications for mother and fetus, and prevention of gestational diabetes. At the end of the three-months intervention period, a face-to-face session, the HBM questionnaire, three-day food record and physical activity questionnaire will be collected.
Category
Prevention
2
Description
Control group: Pregnant women in the control group receive routine pregnancy training and care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
public Health care Centers
Full name of responsible person
Shirin Alipour
Street address
public Health care Centers
City
Omidiyeh
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
alipour.sh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Golestan Highway, Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
alipour.sh@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Shirin Alipour
Position
Master Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Highway, Faculty of Paramedicine, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 613738319
Email
alipour.sh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Borazjani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway, Faculty of Paramedicine ، Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 613738319
Email
borazjani-f@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shirin Alipour
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Golestan Highway, Faculty of Paramedicine, Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 613738319
Email
alipour.sh@ajums.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
Yes - There is 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
Title and more details about the data/document
Investigating the effect of nutritional education on glycemic index based on Health Belief Model (HBM) on determining the risk of gestational diabetes mellitus among pregnant mother referring to health center, Omidiyeh.
When the data will become available and for how long
After the publication of the article
To whom data/document is available
All
Under which criteria data/document could be used
study
From where data/document is obtainable
Fatemeh Borazjani
What processes are involved for a request to access data/document