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Protocol summary
The aim of this study is to assess the effect of diet with low trans fatty acids content on adverse pregnancy outcomes among pregnant women.
In this study women under7 weeks who received prenatal care in health centers of the Shahid Beheshti University of Medical Sciences with inclusion criteria, after filed the consent form recruited in this study. Subjects were randomly divided two groups;intervention group with intake dietary pattern with trans fatty acids content less than 1% and control group with intake dietary pattern without any change on trans fatty acids content. the number of subjects in every group was 400. For all pregnant women was filled 24 dietary recall questionnaire in three days at the and of 13,25 and 35 weeks of pregnancy. all pregnant women were received prenatal care in health center and were assessed for adverse pregnancy outcomes incidence.
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The aim of this study is to assess the effect of diet with low trans fatty acids content on adverse pregnancy outcomes among pregnant women. In this study women under7 weeks who received prenatal care in health centers of the Shahid Beheshti University of Medical Sciences with inclusion criteria, after filed the consent form recruited in this study. Subjects were randomly divided two groups;intervention group with intake dietary pattern with trans fatty acids content less than 1% and control group with intake dietary pattern without any change on trans fatty acids content. the number of subjects in every group was 400. For all pregnant women was filled 24 dietary recall questionnaire in three days at the and of 13,25 and 35 weeks of pregnancy. all pregnant women were received prenatal care in health center and were assessed for adverse pregnancy outcomes incidence.
هدف از انجام این مطالعه، بررسی تاثیر رژیم غذایی با محتوای اسید چرب ترانس پائین بر پیامدهای نامطلوب بارداری در زنان باردار است.
در این مطالعه از زنان بارداری زیر 7 هفته بارداری که برای دریافت مراقبتهای روتین دوران بارداری به مراکز بهداشتی درمانی وابسته به دانشگاه علوم پزشکی شهید بهشتی مراجعه نموده اند و شرایط ورود به مطالعه را داشتند،پس از کسب رضایتنامه کتبی نمونه گیری صورت گرفت. در این مطالعه نمونه ها به صورت تصادفی به دو گروه دریافت کننده رژیم غذایی با اسید چرب ترانس کمتر از 1% و گروه شاهد که دریافت کننده رژیم غذایی معمول بدون تغییر در محتوای اسید چرب ترانس بود، تقسیم شدند. تعداد حجم نمونه ها در هر گروه 400 نفر بود.. برای تمامی زنان باردار در هر دو گروه در انتهای هفته های 13، 25و 35 بارداری برای بررسی رژیم غذایی مصرفی، پرسشنامه یادآمد خوراک 24 ساعته در سه روز پر شد. کلیه زنان باردار مراقبتهای روتین بارداری را در این مراکز دریافت نموده و از نظر بروز پیامدهای نامطلوب بارداری مورد بررسی قرار گرفتند.
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هدف از انجام این مطالعه، بررسی تاثیر رژیم غذایی با محتوای اسید چرب ترانس پائین بر پیامدهای نامطلوب بارداری در زنان باردار است. در این مطالعه از زنان بارداری زیر 7 هفته بارداری که برای دریافت مراقبتهای روتین دوران بارداری به مراکز بهداشتی درمانی وابسته به دانشگاه علوم پزشکی شهید بهشتی مراجعه نموده اند و شرایط ورود به مطالعه را داشتند،پس از کسب رضایتنامه کتبی نمونه گیری صورت گرفت. در این مطالعه نمونه ها به صورت تصادفی به دو گروه دریافت کننده رژیم غذایی با اسید چرب ترانس کمتر از 1% و گروه شاهد که دریافت کننده رژیم غذایی معمول بدون تغییر در محتوای اسید چرب ترانس بود، تقسیم شدند. تعداد حجم نمونه ها در هر گروه 400 نفر بود.. برای تمامی زنان باردار در هر دو گروه در انتهای هفته های 13، 25و 35 بارداری برای بررسی رژیم غذایی مصرفی، پرسشنامه یادآمد خوراک 24 ساعته در سه روز پر شد. کلیه زنان باردار مراقبتهای روتین بارداری را در این مراکز دریافت نموده و از نظر بروز پیامدهای نامطلوب بارداری مورد بررسی قرار گرفتند.
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Effect of low trans‑fatty acid intakes during pregnancy on adverse pregnancy outcomes
Effect of low trans‑fatty acid intakes during pregnancy on adverse pregnancy outcomes
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تاثیر دریافت اسید چرب ترانس پائین در طی بارداری بر عوارض نامطلوب بارداری
تاثیر دریافت اسید چرب ترانس پائین در طی بارداری بر عوارض نامطلوب بارداری
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A randomized controlled clinical trial with an intervention group, without blinding, on 800 pregnant women. Latin randomization and Excel software were used for randomization. The intervention group with the received food pattern with the content of trans fatty acids less than 1% and the control group with the received food pattern without change in the content of trans fatty acids.
A randomized controlled clinical trial with an intervention group, without blinding, on 800 pregnant women. Latin randomization and Excel software were used for randomization. The intervention group with the received food pattern with the content of trans fatty acids less than 1% and the control group with the received food pattern without change in the content of trans fatty acids.
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کارآزمایی بالینی دارای گروه کنترل، با گروه مداخله، بدون کور سازی، بر روی 800 زن باردار. برای تصادفی سازی از مربع لاتین و نرم افزار اکسل استفاده شد.گروه مداخله با الگوی غذایی دریافتی با محتوای اسیدهای چرب ترانس کمتر از 1٪ و گروه کنترل با الگوی غذایی دریافتی بدون تغییر درمحتوای اسیدهای چرب ترانس.
کارآزمایی بالینی دارای گروه کنترل، با گروه مداخله، بدون کور سازی، بر روی 800 زن باردار. برای تصادفی سازی از مربع لاتین و نرم افزار اکسل استفاده شد.گروه مداخله با الگوی غذایی دریافتی با محتوای اسیدهای چرب ترانس کمتر از 1٪ و گروه کنترل با الگوی غذایی دریافتی بدون تغییر درمحتوای اسیدهای چرب ترانس.
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This clinical trial study was performed in health centers affiliated to Shahid Beheshti University of Medical Sciences. For pregnant women in intervention group was designed to have a trans fatty acid intake of less than 1%, but this change was not observed in the diet of pregnant women in the control group.
No blinding was performed in this study.
This clinical trial study was performed in health centers affiliated to Shahid Beheshti University of Medical Sciences. For pregnant women in intervention group was designed to have a trans fatty acid intake of less than 1%, but this change was not observed in the diet of pregnant women in the control group. No blinding was performed in this study.
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این مطالعه کارآزمایی بالینی در مراکز بهداشتی درمانی وابسته به دانشگاه علوم پزشکی شهید بهشتی انجام شده است. برای زنان باردار در گروه مداخله ، مصرف اسید چرب ترانس کمتر از 1٪ طراحی شده بود ، اما این تغییر در رژیم غذایی زنان باردار در گروه کنترل مشاهده نشد.
هیچ کورسازی در این مطالعه انجام نشده است.
این مطالعه کارآزمایی بالینی در مراکز بهداشتی درمانی وابسته به دانشگاه علوم پزشکی شهید بهشتی انجام شده است. برای زنان باردار در گروه مداخله ، مصرف اسید چرب ترانس کمتر از 1٪ طراحی شده بود ، اما این تغییر در رژیم غذایی زنان باردار در گروه کنترل مشاهده نشد. هیچ کورسازی در این مطالعه انجام نشده است.
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Inclusion criteria: Pregnant women with normal pregnancy and gestational age less than 8 weeks
Exclusion criteria: Pregnant women with chronic disease with a history of preeclampsia, gestational diabetes and low birth weight baby
Inclusion criteria: Pregnant women with normal pregnancy and gestational age less than 8 weeks Exclusion criteria: Pregnant women with chronic disease with a history of preeclampsia, gestational diabetes and low birth weight baby
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معیار ورود: زنان باردار با بارداری نرمال و سن حاملگی کمتر از 8 هفته
معیار خروج: زنان باردار دارای بیماری مزمن با سابقه پراکلامپسی و دیابت بارداری و نوزاد با وزن کم هنگام تولد
معیار ورود: زنان باردار با بارداری نرمال و سن حاملگی کمتر از 8 هفته معیار خروج: زنان باردار دارای بیماری مزمن با سابقه پراکلامپسی و دیابت بارداری و نوزاد با وزن کم هنگام تولد
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Women in intervention group received individualized dietary pattern with trans fatty acids content under 1% of total daily energy intake, and in the control group, women received individualized dietary pattern without any focus on trans fatty acids content. Women in control group received individualized dietary pattern without any change in trans fatty acids content.
Women in intervention group received individualized dietary pattern with trans fatty acids content under 1% of total daily energy intake, and in the control group, women received individualized dietary pattern without any focus on trans fatty acids content. Women in control group received individualized dietary pattern without any change in trans fatty acids content.
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زنان در گروه مداخله الگوی غذایی منحصر به فرد با محتوای اسید چرب ترانس زیر 1٪ از کل انرژی دریافتی روزانه را دریافت کردند و در گروه کنترل، زنان الگوی غذایی فردی را بدون تمرکز بر محتوای اسید چرب ترانس دریافت کردند. زنان در گروه کنترل الگوی غذایی منحصر به فرد بدون تغییر در محتوای اسید چرب ترانس دریافت کردند.
زنان در گروه مداخله الگوی غذایی منحصر به فرد با محتوای اسید چرب ترانس زیر 1٪ از کل انرژی دریافتی روزانه را دریافت کردند و در گروه کنترل، زنان الگوی غذایی فردی را بدون تمرکز بر محتوای اسید چرب ترانس دریافت کردند. زنان در گروه کنترل الگوی غذایی منحصر به فرد بدون تغییر در محتوای اسید چرب ترانس دریافت کردند.
The reason for the update is to extract the results of this clinical trial.
This study showed that a diet low in trans fatty acids can reduce the incidence of gestational diabetes, low birth weight and preeclampsia.
Of the 800 women (n=407 in control and n=393 in intervention groups), 108 (13.5%) women were diagnosed with low birth weight. The incidence of low birth weight in intervention group was 12% and in control group was 19%. After multivariable adjustment for confounders, the hazard ratios for incident low birth weight in intervention group were 0.65 (0.44-0.96). Kaplan-Meier plot showed significant difference between two groups in incidence of low birth weight.
There were statistically significant differences in intakes of daily trans fatty acids between the groups (P < 0.05). The hazard ratio (95% CI) for the incidence of preeclampsia in the intervention group was 0.56 (0.33–0.93).
14 women in the intervention group (5%) and 31 women in the control group (8%) were diagnosed with gestational diabetes mellitus. Chi-square test did not show any significant difference between two groups (P=0.08). Cox model was used and the variables were examined in four multivariate models that none of the modals showed a statistically significant difference between the two groups regarding the incidence of GDM.
The reason for the update is to extract the results of this clinical trial. This study showed that a diet low in trans fatty acids can reduce the incidence of gestational diabetes, low birth weight and preeclampsia. Of the 800 women (n=407 in control and n=393 in intervention groups), 108 (13.5%) women were diagnosed with low birth weight. The incidence of low birth weight in intervention group was 12% and in control group was 19%. After multivariable adjustment for confounders, the hazard ratios for incident low birth weight in intervention group were 0.65 (0.44-0.96). Kaplan-Meier plot showed significant difference between two groups in incidence of low birth weight. There were statistically significant differences in intakes of daily trans fatty acids between the groups (P < 0.05). The hazard ratio (95% CI) for the incidence of preeclampsia in the intervention group was 0.56 (0.33–0.93). 14 women in the intervention group (5%) and 31 women in the control group (8%) were diagnosed with gestational diabetes mellitus. Chi-square test did not show any significant difference between two groups (P=0.08). Cox model was used and the variables were examined in four multivariate models that none of the modals showed a statistically significant difference between the two groups regarding the incidence of GDM.
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علت بروز رسانی، استخراج نتایج حاصل از این کارازمایی بالینی می باشدو بارگزاری آن در سیستم برای اطلاع رسانی به عموم می باشد.
این مطالعه نشان داد که رژیم غذایی با محتوای اسید چرب ترانس پائین می تواند منجر به کاهش بروز وزن کم هنگام تولد و پراکلامپسی گردد، اما بر روی بروز دیابت بارداری تاثیرگذار نبود.
از 800 زن (407 نفر در گروه کنترل و 393 نفر در گروه مداخله) ، 108 (13.5٪) زن با وزن کم تولد تشخیص داده شدند. بروز وزن كم هنگام تولد در گروه مداخله 12٪ و در گروه شاهد 19٪ بود. پس از تعدیل چند متغیره برای عوامل مخدوش کننده ، نسبت خطر برای وزن کم هنگام تولد در گروه مداخله 0/65 (0/96-0/44) بود. نمودارکاپلان مایراختلاف معنی داری را در بروز وزن کم هنگام تولد بین دو گروه نشان داد.
از نظر آماری اختلاف معنی داری در میزان مصرف اسیدهای چرب ترانس روزانه بین گروه ها وجود داشت (P <0.05). نسبت خطر (95٪ CI) برای بروز پره اکلامپسی در گروه مداخله 0.56 (0.33-0.93) بود.
14 زن در گروه مداخله (5٪) و 31 زن در گروه شاهد (8٪) با دیابت بارداری تشخیص داده شدند. آزمون مجذور کای تفاوت معنی داری بین دو گروه نشان نداد (0/08 = P). از مدل کاکس استفاده شد و متغیرها در چهار مدل چند متغیره مورد بررسی قرار گرفتند که هیچ یک از مدل ها از نظر آماری تفاوت معنی داری بین دو گروه نشان نداد.
علت بروز رسانی، استخراج نتایج حاصل از این کارازمایی بالینی می باشدو بارگزاری آن در سیستم برای اطلاع رسانی به عموم می باشد. این مطالعه نشان داد که رژیم غذایی با محتوای اسید چرب ترانس پائین می تواند منجر به کاهش بروز وزن کم هنگام تولد و پراکلامپسی گردد، اما بر روی بروز دیابت بارداری تاثیرگذار نبود. از 800 زن (407 نفر در گروه کنترل و 393 نفر در گروه مداخله) ، 108 (13.5٪) زن با وزن کم تولد تشخیص داده شدند. بروز وزن كم هنگام تولد در گروه مداخله 12٪ و در گروه شاهد 19٪ بود. پس از تعدیل چند متغیره برای عوامل مخدوش کننده ، نسبت خطر برای وزن کم هنگام تولد در گروه مداخله 0/65 (0/96-0/44) بود. نمودارکاپلان مایراختلاف معنی داری را در بروز وزن کم هنگام تولد بین دو گروه نشان داد. از نظر آماری اختلاف معنی داری در میزان مصرف اسیدهای چرب ترانس روزانه بین گروه ها وجود داشت (P <0.05). نسبت خطر (95٪ CI) برای بروز پره اکلامپسی در گروه مداخله 0.56 (0.33-0.93) بود. 14 زن در گروه مداخله (5٪) و 31 زن در گروه شاهد (8٪) با دیابت بارداری تشخیص داده شدند. آزمون مجذور کای تفاوت معنی داری بین دو گروه نشان نداد (0/08 = P). از مدل کاکس استفاده شد و متغیرها در چهار مدل چند متغیره مورد بررسی قرار گرفتند که هیچ یک از مدل ها از نظر آماری تفاوت معنی داری بین دو گروه نشان نداد.
The effect of low Trans Fatty Acid content diet on adverse pregnancy outcomes among pregnant women who are attending health center of Shahid Beheshti University Of Medical Sciences
The effect of low trans fatty acid diet on adverse pregnancy outcomes
The effect of low Trans Fatty Acid contenttrans fatty acid diet on adverse pregnancy outcomes among pregnant women who are attending health center of Shahid Beheshti University Of Medical Sciences
تاثیر رژیم غذایی با محتوای اسید چرب ترانس پایین بر پیامدهای نامطلوب بارداری در زنان باردار مراجعه کننده به مراکز بهداشتی دانشگاه علوم پزشکی شهید بهشتی
بررسی اثر رژیم غذایی حاوی اسید چرب ترانس کم بر نتایج نامطلوب بارداری
تاثیربررسی اثر رژیم غذایی با محتوایحاوی اسید چرب ترانس پایینکم بر پیامدهاینتایج نامطلوب بارداری در زنان باردار مراجعه کننده به مراکز بهداشتی دانشگاه علوم پزشکی شهید بهشتی
Pregnant women aged 18-35 years.
Pregnant women who are less than 7 weeks pregnant.
Pregnant women with singleton pregnancies.
Pre pregnancy body mass index 19-25 kg/m2
Pregnant women who have a pre-pregnancy body mass index of 19-25 kg / m2.
Pregnant women who are literate.
Pregnant women aged 18-35 years. Pregnant women who are less than 7 weeks pregnant. Pregnant women with singleton pregnancies. Pre pregnancy body mass index 19-25 kg/m2 Pregnant women who have a pre-pregnancy body mass index of 19-25 kg / m2. Pregnant women who are literate.
زنان باردار که سن 35-18 سال دارند.
زنان باردار که سن بارداری زیر 7هفته دارند.
زنان باردار که دارای حاملگی تک قلوهستند.
زنان باردار که شاخص توده بدنی قبل از بارداری 25-19کیلوگرم بر مترمربع دارند.
زنان باردار که رژیم غذایی نرمال دارند.
زنان باردار که سواد خواندن و نوشتن دارند.
زنان باردار که سن 35-18 سال دارند. زنان باردار که سن بارداری زیر 7هفته دارند. زنان باردار که دارای حاملگی تک قلوهستند. زنان باردار که شاخص توده بدنی قبل از بارداری 25-19کیلوگرم بر مترمربع دارند. زنان باردار که رژیم غذایی نرمال دارند. زنان باردار که سواد خواندن و نوشتن دارند.
Diagnose fetal abnormalities in the current pregnancy.
Pregnant women with severe nausea and vomiting during pregnancy.
Pregnant women who smoke.
Pregnant women who drink alcohol.
Pregnant women who are addicted to drugs.
Diagnose fetal abnormalities in the current pregnancy. Pregnant women with severe nausea and vomiting during pregnancy. Pregnant women who smoke. Pregnant women who drink alcohol. Pregnant women who are addicted to drugs.
تشخیص ناهنجاری های جنینی در بارداری فعلی داده شود.
زنان بارداری که تهوع و استفراغ شدید بارداری دارند.
زنان بارداری که سیگار مصرف می کنند.
زنان بارداری که الکل مصرف می کنند.
زنان بارداری که اعتیاد به مواد مخدر دارند.
تشخیص ناهنجاری های جنینی در بارداری فعلی داده شود. زنان بارداری که تهوع و استفراغ شدید بارداری دارند. زنان بارداری که سیگار مصرف می کنند. زنان بارداری که الکل مصرف می کنند. زنان بارداری که اعتیاد به مواد مخدر دارند.
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Intervention (dietary pattern with trans fatty acids<1%) and control through blocked randomization in block sizes of four and six and with an allocation ratio of 1:1. To conceal the allocation, the type of intervention (dietary pattern with trans fatty acids<1% or routine diet) was written on paper and placed into sequentially numbered opaque envelopes. The researcher opened the envelopes sequentially when a participant entered into the study, and, depending on the type of group written on the paper in the envelope, the participants were allocated to the relevant group. Blocking was done by a person not involved in the sampling.
Intervention (dietary pattern with trans fatty acids<1%) and control through blocked randomization in block sizes of four and six and with an allocation ratio of 1:1. To conceal the allocation, the type of intervention (dietary pattern with trans fatty acids<1% or routine diet) was written on paper and placed into sequentially numbered opaque envelopes. The researcher opened the envelopes sequentially when a participant entered into the study, and, depending on the type of group written on the paper in the envelope, the participants were allocated to the relevant group. Blocking was done by a person not involved in the sampling.
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گروه مداخله (الگوی غذایی با اسیدهای چرب ترانس <1٪) و کنترل در اندازه بلوک های چهار و شش و با نسبت تخصیص 1: 1. برای پنهان کردن تخصیص تصادفی شدند. نوع مداخله (الگوی غذایی با اسیدهای چرب ترانس <1٪ یا رژیم غذایی معمول) بر روی کاغذ نوشته شده و در پاکتهای مات با شماره متوالی قرار داده شدند. هنگام ورود یک شرکت کننده به مطالعه ، محققان پاکت نامه ها را به ترتیب باز می کرد و بسته به نوع گروهی که روی کاغذ نوشته شده بود ، شرکت کنندگان به گروه مربوطه اختصاص می یافتند. تخصیص تصادفی توسط شخصی انجام می شد که در نمونه گیری درگیر نشده است.
گروه مداخله (الگوی غذایی با اسیدهای چرب ترانس <1٪) و کنترل در اندازه بلوک های چهار و شش و با نسبت تخصیص 1: 1. برای پنهان کردن تخصیص تصادفی شدند. نوع مداخله (الگوی غذایی با اسیدهای چرب ترانس <1٪ یا رژیم غذایی معمول) بر روی کاغذ نوشته شده و در پاکتهای مات با شماره متوالی قرار داده شدند. هنگام ورود یک شرکت کننده به مطالعه ، محققان پاکت نامه ها را به ترتیب باز می کرد و بسته به نوع گروهی که روی کاغذ نوشته شده بود ، شرکت کنندگان به گروه مربوطه اختصاص می یافتند. تخصیص تصادفی توسط شخصی انجام می شد که در نمونه گیری درگیر نشده است.
empty
empty
empty
empty
Health conditions studied
#1
014
O14
014O14
Gestational [pregnancy-induced] hypertension with significant proteinuria
Pre-eclampsia
Gestational [pregnancyPre-induced] hypertension with significant proteinuriaeclampsia
#2
empty
P05.18
P05.18
empty
Newborn small for gestational age, 2000-2499 grams
Newborn small for gestational age, 2000-2499 grams
empty
Low birth weight
Low birth weight
empty
وزن کم هنگام تولد
وزن کم هنگام تولد
#3
empty
O24.41
O24.41
empty
Gestational diabetes mellitus in pregnancy
Gestational diabetes mellitus in pregnancy
empty
Gestational diabetes mellitus
Gestational diabetes mellitus
empty
دیابت بارداری
دیابت بارداری
Primary outcomes
#1
preeclampsia
Preeclampsia
preeclampsiaPreeclampsia
questionnair
Midwifery questionnaire
questionnairMidwifery questionnaire
پرسشنامه
پرسشنامه مامایی
پرسشنامه مامایی
Secondary outcomes
#1
gestational diabetes
Gestational diabetes
gestationalGestational diabetes
دیابت بارداری
بروز دیابت بارداری
بروز دیابت بارداری
questioneire
Midwifery questionnaire
questioneireMidwifery questionnaire
پرسشنامه
پرسشنامه مامایی
پرسشنامه مامایی
#2
empty
Low birth weight
Low birth weight
empty
وزن کم هنگام تولد
وزن کم هنگام تولد
empty
At birth time
At birth time
empty
زمان تولد
زمان تولد
empty
Measurement with weight of Mark Seka
Measurement with weight of Mark Seka
empty
اندازه گیری با وزنه سکا
اندازه گیری با وزنه سکا
Intervention groups
#1
intervention group: dietary pattern with trans fatty content less than 1%
Intervention group: Women in intervention group received individualized dietary pattern with trans fatty acids content under 1% of total daily energy intake. we replaced mono- and polyunsaturated fatty acids with free of trans fatty acids in dietary pattern, such as olive oil, fish, nuts, and low fat (1.5%) dairy products, and participants were forbidden to consume the food rich of trans fatty acids such as any kind of fast foods, processed meat, and deep fried foods.
Intervention group: Women in intervention group: received individualized dietary pattern with trans fatty acids content less thanunder 1% of total daily energy intake. we replaced mono- and polyunsaturated fatty acids with free of trans fatty acids in dietary pattern, such as olive oil, fish, nuts, and low fat (1.5%) dairy products, and participants were forbidden to consume the food rich of trans fatty acids such as any kind of fast foods, processed meat, and deep fried foods.
گروه مداخله: رژیم غذایی با محتوای اسید چرب ترانس کمتر از %1
گروه مداخله: زنان گروه مداخله الگوی غذایی فردی با محتوای اسیدهای چرب ترانس زیر 1٪ کل انرژی دریافتی روزانه دریافت کردند. ما اسیدهای چرب ا تک و چند اشباع نشده را بدون اسیدهای چرب ترانس در رژیم غذایی ، مانند روغن زیتون ، ماهی ، آجیل و لبنیات کم چربی (1.5٪) جایگزین کردیم و مصرف مواد غذایی غنی از اسیدهای چرب ترانس مانند هر نوع فست فود ، گوشت فرآوری شده و غذاهای عمیق سرخ شده ممنوع شدند.
گروه مداخله: رژیمزنان گروه مداخله الگوی غذایی فردی با محتوای اسیداسیدهای چرب ترانس کمترزیر 1٪ کل انرژی دریافتی روزانه دریافت کردند. ما اسیدهای چرب ا تک و چند اشباع نشده را بدون اسیدهای چرب ترانس در رژیم غذایی ، مانند روغن زیتون ، ماهی ، آجیل و لبنیات کم چربی (1.5٪) جایگزین کردیم و مصرف مواد غذایی غنی از %1اسیدهای چرب ترانس مانند هر نوع فست فود ، گوشت فرآوری شده و غذاهای عمیق سرخ شده ممنوع شدند.
#2
Control group: dietary pattern with any change on trans fatty acids content
women received individualized dietary pattern without any focus on trans fatty acid content. women were allowed to consume any kind of dairy products and oil for cooking and routine dietary recommendation were advised.
Control group:women received individualized dietary pattern withwithout any changefocus on trans fatty acidsacid content. women were allowed to consume any kind of dairy products and oil for cooking and routine dietary recommendation were advised.
گروه کنترل: رژیم غذایی بدون تغییر در محتوای اسید چرب ترانس
زنان بدون تمرکز بر محتوای اسید چرب ترانس الگوی غذایی فردی دریافت کردند. زنان مجاز به استفاده از هر نوع لبنیات و روغن برای پخت و پز هستند و توصیه های معمول رژیم غذایی به آنها توصیه می شود.
گروه کنترل: رژیم غذاییزنان بدون تغییر درتمرکز بر محتوای اسید چرب ترانس الگوی غذایی فردی دریافت کردند. زنان مجاز به استفاده از هر نوع لبنیات و روغن برای پخت و پز هستند و توصیه های معمول رژیم غذایی به آنها توصیه می شود.
Recruitment centers
#1
Name of recruitment center - English: Taleghani Hospital
Name of recruitment center - Persian: بیمارستان طالقانی
Full name of responsible person - English: Seideh Hanieh Alamolhoda
Full name of responsible person - Persian: سیده هانیه علم الهدی
Street address - English: Taleghani Hospital, Velenjak, Tehran
Street address - Persian: تهران، ولنجک، بیمارستان طالقانی
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Taleghani Hospital
Name of recruitment center - Persian: بیمارستان طالقانی
Full name of responsible person - English: Seideh Hanieh Alamolhoda
Full name of responsible person - Persian: سیده هانیه علم الهدی
Street address - English: Taleghani Hospital, Velenjak, Tehran
Street address - Persian: تهران، ولنجک، بیمارستان طالقانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1155673970
Phone: +98 21 8820 2512
Fax:
Email: alamolhoda.h@gmail.com
Web page address:
Name of recruitment center - English: Taleghani Hospital Name of recruitment center - Persian: بیمارستان طالقانی Full name of responsible person - English: Seideh Hanieh Alamolhoda Full name of responsible person - Persian: سیده هانیه علم الهدی Street address - English: Taleghani Hospital, Velenjak, Tehran Street address - Persian: تهران، ولنجک، بیمارستان طالقانی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1155673970 Phone: +98 21 8820 2512 Fax: Email: alamolhoda.h@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice Chancellor Of Research, Shahid Beheshti University Of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Mahrokh Dolatian
Full name of responsible person - Persian: ماهرخ دولتیان
Street address - English: Shahid Beheshti University Of Medical Sciences, Velenjak, Tehran
Street address - Persian: تهران، ولنجک، دانشگاه علوم پزشکی شهید بهشتی
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: Vice Chancellor Of Research, Shahid Beheshti University Of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Mahrokh Dolatian
Full name of responsible person - Persian: ماهرخ دولتیان
Street address - English: Shahid Beheshti University Of Medical Sciences, Velenjak, Tehran
Street address - Persian: تهران، ولنجک، دانشگاه علوم پزشکی شهید بهشتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1155673970
Phone: +98 21 8820 2512
Fax:
Email: alamolhoda.h@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Vice Chancellor Of Research, Shahid Beheshti University Of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی شهید بهشتی Full name of responsible person - English: Mahrokh Dolatian Full name of responsible person - Persian: ماهرخ دولتیان Street address - English: Shahid Beheshti University Of Medical Sciences, Velenjak, Tehran Street address - Persian: تهران، ولنجک، دانشگاه علوم پزشکی شهید بهشتی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1155673970 Phone: +98 21 8820 2512 Fax: Email: alamolhoda.h@gmail.com Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Seideh Hanieh Alamolhoda
Full name of responsible person - Persian: سیده هانیه علم الهدی
Position - English: Faculty Member of Nursing and Midwifery Faculty
Position - Persian: هیات علمی دانشکده پرستاری و مامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
Street address - Persian: تقاطع خیابان ولیعصر و بزرگراه نیایش، دانشکده پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 8820 2512
Mobile: +98 912 736 3091
Fax: +98 21 8820 2512
Email: alamolhoda.h@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Seideh Hanieh Alamolhoda
Full name of responsible person - Persian: سیده هانیه علم الهدی
Position - English: Faculty Member of Nursing and Midwifery Faculty
Position - Persian: هیات علمی دانشکده پرستاری و مامایی
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
Street address - Persian: تقاطع خیابان ولیعصر و بزرگراه نیایش، دانشکده پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1155673970
Phone: +98 21 8820 2512
Mobile: +98 912 736 3091
Fax: +98 21 8820 2512
Email: alamolhoda.h@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahid Beheshti University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی Full name of responsible person - English: Seideh Hanieh Alamolhoda Full name of responsible person - Persian: سیده هانیه علم الهدی Position - English: Faculty Member of Nursing and Midwifery Faculty Position - Persian: هیات علمی دانشکده پرستاری و مامایی Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction Street address - Persian: تقاطع خیابان ولیعصر و بزرگراه نیایش، دانشکده پرستاری و مامایی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1155673970 Phone: +98 21 8820 2512 Mobile: +98 912 736 3091 Fax: +98 21 8820 2512 Email: alamolhoda.h@gmail.com Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Seideh Hanieh Alamolhoda
Full name of responsible person - Persian: سیده هانیه علم الهدی
Position - English: Faculty Member of Nursing and Midwifery Faculty
Position - Persian: هیات علمی دانشکده پرستاری ومامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
Street address - Persian: تقاطع خیابان ولیعصر و بزرگراه نیایش، دانشکده پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 8820 2512
Mobile: 00
Fax:
Email: alamolhoda.h@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Seideh Hanieh Alamolhoda
Full name of responsible person - Persian: سیده هانیه علم الهدی
Position - English: Faculty Member of Nursing and Midwifery Faculty
Position - Persian: هیات علمی دانشکده پرستاری ومامایی
Latest degree: phd
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
Street address - Persian: تقاطع خیابان ولیعصر و بزرگراه نیایش، دانشکده پرستاری و مامایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1155673970
Phone: +98 21 8820 2512
Mobile: +98 912 200 7685
Fax:
Email: alamolhoda.h@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahid Beheshti University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی Full name of responsible person - English: Seideh Hanieh Alamolhoda Full name of responsible person - Persian: سیده هانیه علم الهدی Position - English: Faculty Member of Nursing and Midwifery Faculty Position - Persian: هیات علمی دانشکده پرستاری ومامایی Latest degree: phd Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction Street address - Persian: تقاطع خیابان ولیعصر و بزرگراه نیایش، دانشکده پرستاری و مامایی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1155673970 Phone: +98 21 8820 2512 Mobile: 00+98 912 200 7685 Fax: Email: alamolhoda.h@gmail.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Seideh Hanieh Alamolhoda
Full name of responsible person - Persian: سیده هانیه علم الهدی
Position - English: Faculty Member of Nursing and Midwifery Faculty
Position - Persian: هیات علمی دانشکده پرستاری ومامایی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
Street address - Persian: تقاطع خیابان ولیعصر و بزرگراه نیایش، دانشکده پرستاری ومامایی
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 21 8820 2512
Mobile: +98 912 736 3091
Fax: +98 21 8820 2512
Email: alamolhoha.h@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shahid Beheshti University Of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی
Full name of responsible person - English: Seideh Hanieh Alamolhoda
Full name of responsible person - Persian: سیده هانیه علم الهدی
Position - English: Faculty Member of Nursing and Midwifery Faculty
Position - Persian: هیات علمی دانشکده پرستاری ومامایی
Latest degree: master
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
Street address - Persian: تقاطع خیابان ولیعصر و بزرگراه نیایش، دانشکده پرستاری ومامایی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1155673970
Phone: +98 21 8820 2512
Mobile: +98 912 736 3091
Fax: +98 21 8820 2512
Email: alamolhoha.h@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shahid Beheshti University Of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی شهید بهشتی Full name of responsible person - English: Seideh Hanieh Alamolhoda Full name of responsible person - Persian: سیده هانیه علم الهدی Position - English: Faculty Member of Nursing and Midwifery Faculty Position - Persian: هیات علمی دانشکده پرستاری ومامایی Latest degree: master Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction Street address - Persian: تقاطع خیابان ولیعصر و بزرگراه نیایش، دانشکده پرستاری ومامایی City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1155673970 Phone: +98 21 8820 2512 Mobile: +98 912 736 3091 Fax: +98 21 8820 2512 Email: alamolhoha.h@gmail.com Web page address:
Sharing plan
yes
yes
no
no
yes
yes
yes
yes
yes
yes
yes
yes
na
na
empty
Low trans fatty acid and gestational diabetes mellitus
Low trans fatty acid and preeclampsia
Low trans fatty acid and low birth weight
Low trans fatty acid and gestational diabetes mellitus Low trans fatty acid and preeclampsia Low trans fatty acid and low birth weight
empty
رژیم غذایی با اسید چرب ترانس پائین و دیابت بارداری
رژیم غذایی با اسید چرب ترانس پائین و پراکلامپسی
رژیم غذایی با اسید چرب ترانس پائین و وزن کم هنگام تولد
رژیم غذایی با اسید چرب ترانس پائین و دیابت بارداری رژیم غذایی با اسید چرب ترانس پائین و پراکلامپسی رژیم غذایی با اسید چرب ترانس پائین و وزن کم هنگام تولد
empty
2018
2018
empty
1396
1396
empty
Public
Public
empty
عمومی
عمومی
empty
No criteria need
No criteria need
empty
شرطی نیاز نیست
شرطی نیاز نیست
empty
Physicians
Midwifes
Health care giver
Physicians Midwifes Health care giver
empty
پزشکان
ماماها
ارائه دهندگان خدمات بهداشتی
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Protocol summary
Study aim
Effect of low trans‑fatty acid intakes during pregnancy on adverse pregnancy outcomes
Design
A randomized controlled clinical trial with an intervention group, without blinding, on 800 pregnant women. Latin randomization and Excel software were used for randomization. The intervention group with the received food pattern with the content of trans fatty acids less than 1% and the control group with the received food pattern without change in the content of trans fatty acids.
Settings and conduct
This clinical trial study was performed in health centers affiliated to Shahid Beheshti University of Medical Sciences. For pregnant women in intervention group was designed to have a trans fatty acid intake of less than 1%, but this change was not observed in the diet of pregnant women in the control group.
No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pregnant women with normal pregnancy and gestational age less than 8 weeks
Exclusion criteria: Pregnant women with chronic disease with a history of preeclampsia, gestational diabetes and low birth weight baby
Intervention groups
Women in intervention group received individualized dietary pattern with trans fatty acids content under 1% of total daily energy intake, and in the control group, women received individualized dietary pattern without any focus on trans fatty acids content. Women in control group received individualized dietary pattern without any change in trans fatty acids content.
The reason for the update is to extract the results of this clinical trial.
This study showed that a diet low in trans fatty acids can reduce the incidence of gestational diabetes, low birth weight and preeclampsia.
Of the 800 women (n=407 in control and n=393 in intervention groups), 108 (13.5%) women were diagnosed with low birth weight. The incidence of low birth weight in intervention group was 12% and in control group was 19%. After multivariable adjustment for confounders, the hazard ratios for incident low birth weight in intervention group were 0.65 (0.44-0.96). Kaplan-Meier plot showed significant difference between two groups in incidence of low birth weight.
There were statistically significant differences in intakes of daily trans fatty acids between the groups (P < 0.05). The hazard ratio (95% CI) for the incidence of preeclampsia in the intervention group was 0.56 (0.33–0.93).
14 women in the intervention group (5%) and 31 women in the control group (8%) were diagnosed with gestational diabetes mellitus. Chi-square test did not show any significant difference between two groups (P=0.08). Cox model was used and the variables were examined in four multivariate models that none of the modals showed a statistically significant difference between the two groups regarding the incidence of GDM.
Acronym
IRCT registration information
IRCT registration number:IRCT2016092729902N3
Registration date:2016-11-08, 1395/08/18
Registration timing:retrospective
Last update:2020-12-07, 1399/09/17
Update count:1
Registration date
2016-11-08, 1395/08/18
Registrant information
Name
Seideh Hanieh Alamolhoda
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
h_alamolhoda@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
common project between Nursing and Midwifery Faculty with Endocrine and Metabolism Research Center of Shahid Beheshti University Of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low Trans Fatty Acid content diet on adverse pregnancy outcomes
Public title
The effect of low trans fatty acid diet on adverse pregnancy outcomes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 18-35 years.
Pregnant women who are less than 7 weeks pregnant.
Pregnant women with singleton pregnancies.
Pre pregnancy body mass index 19-25 kg/m2
Pregnant women who have a pre-pregnancy body mass index of 19-25 kg / m2.
Pregnant women who are literate.
Exclusion criteria:
Diagnose fetal abnormalities in the current pregnancy.
Pregnant women with severe nausea and vomiting during pregnancy.
Pregnant women who smoke.
Pregnant women who drink alcohol.
Pregnant women who are addicted to drugs.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
800
Randomization (investigator's opinion)
Randomized
Randomization description
Intervention (dietary pattern with trans fatty acids<1%) and control through blocked randomization in block sizes of four and six and with an allocation ratio of 1:1. To conceal the allocation, the type of intervention (dietary pattern with trans fatty acids<1% or routine diet) was written on paper and placed into sequentially numbered opaque envelopes. The researcher opened the envelopes sequentially when a participant entered into the study, and, depending on the type of group written on the paper in the envelope, the participants were allocated to the relevant group. Blocking was done by a person not involved in the sampling.
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
Ethics Committee Of Shahid Beheshti University Of Medical Sciences
Street address
Shahid Beheshti University Of Medical Sciences, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1155673970
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.SBMU.ries.Rec.1394.92
Health conditions studied
1
Description of health condition studied
preeclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
2
Description of health condition studied
Low birth weight
ICD-10 code
P05.18
ICD-10 code description
Newborn small for gestational age, 2000-2499 grams
3
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.41
ICD-10 code description
Gestational diabetes mellitus in pregnancy
Primary outcomes
1
Description
Preeclampsia
Timepoint
28 weeks of pregnancy
Method of measurement
Midwifery questionnaire
Secondary outcomes
1
Description
Gestational diabetes
Timepoint
28 weeks of pregnancy
Method of measurement
Midwifery questionnaire
2
Description
Low birth weight
Timepoint
At birth time
Method of measurement
Measurement with weight of Mark Seka
Intervention groups
1
Description
Intervention group: Women in intervention group received individualized dietary pattern with trans fatty acids content under 1% of total daily energy intake. we replaced mono- and polyunsaturated fatty acids with free of trans fatty acids in dietary pattern, such as olive oil, fish, nuts, and low fat (1.5%) dairy products, and participants were forbidden to consume the food rich of trans fatty acids such as any kind of fast foods, processed meat, and deep fried foods.
Category
Prevention
2
Description
women received individualized dietary pattern without any focus on trans fatty acid content. women were allowed to consume any kind of dairy products and oil for cooking and routine dietary recommendation were advised.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Seideh Hanieh Alamolhoda
Street address
Taleghani Hospital, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1155673970
Phone
+98 21 8820 2512
Email
alamolhoda.h@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Shahid Beheshti University Of Medical Sciences, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1155673970
Phone
+98 21 8820 2512
Email
alamolhoda.h@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Shahid Beheshti 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
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Seideh Hanieh Alamolhoda
Position
Faculty Member of Nursing and Midwifery Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
City
Tehran
Province
Tehran
Postal code
1155673970
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
alamolhoda.h@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Seideh Hanieh Alamolhoda
Position
Faculty Member of Nursing and Midwifery Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
City
Tehran
Province
Tehran
Postal code
1155673970
Phone
+98 21 8820 2512
Fax
Email
alamolhoda.h@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Seideh Hanieh Alamolhoda
Position
Faculty Member of Nursing and Midwifery Faculty
Latest degree
Master
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, Valiasr street and Niayesh highway junction
City
Tehran
Province
Tehran
Postal code
1155673970
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
alamolhoha.h@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Low trans fatty acid and gestational diabetes mellitus
Low trans fatty acid and preeclampsia
Low trans fatty acid and low birth weight
When the data will become available and for how long
2018
To whom data/document is available
Public
Under which criteria data/document could be used
No criteria need
From where data/document is obtainable
Physicians
Midwifes
Health care giver
What processes are involved for a request to access data/document