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Protocol summary
The Comparison of the Effects of Two Education Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
The Comparison of the Effects of Two Educational Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
The Comparison of the Effects of Two EducationEducational Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
Three parallel group randomized trial which 377 patients participated.
Three parallel group randomized trial which 378 patients participated.
Three parallel group randomized trial which 377378 patients participated.
یک کارآزمایی تصادفی سازی شده سه گروه موازی که 377 بیمار شرکت نمودند.
یک کارآزمایی تصادفی سازی شده سه گروه موازی که 378 بیمار شرکت نمودند.
یک کارآزمایی تصادفی سازی شده سه گروه موازی که 377378 بیمار شرکت نمودند.
This study was performed in the diabetic clinic affiliated to Ahvaz University of Medical Sciences. Participants will be allocated to verbal education group, video education group and control group.
This study was performed in the diabetic clinic affiliated to Ahvaz University of Medical Sciences. Participants were allocated to oral education group, video education group and control group.
This study was performed in the diabetic clinic affiliated to Ahvaz University of Medical Sciences. Participants will bewere allocated to verbaloral education group, video education group and control group.
شرایط ورود به مطالعه: سن هجده سال یا بیشتر، قادر به صحبت به عربی یا فارسی باشد. شرایط عدم ورود به مطالعه: ابتلا به سایر بیماری های مزمن، اختلال در بینایی، شنوایی و صحبت کردن، باردار باشد.
شرایط ورود به مطالعه: سن هجده سال یا بیشتر، قادر به صحبت به عربی یا فارسی باشد.
شرایط عدم ورود به مطالعه: ابتلا به سایر بیماری های مزمن، اختلال در بینایی، شنوایی و صحبت کردن، باردار باشد.
شرایط ورود به مطالعه: سن هجده سال یا بیشتر، قادر به صحبت به عربی یا فارسی باشد. شرایط عدم ورود به مطالعه: ابتلا به سایر بیماری های مزمن، اختلال در بینایی، شنوایی و صحبت کردن، باردار باشد.
Participants will be allocated to verbal education group, video education group and control group. The participants in the oral education group received 2 educational sessions during a two-week interval. The participants in the video education group received educational movie.
Participants were allocated to verbal education, video education, and control groups. The participants in the oral education group received four educational sessions during a two-week interval. The participants in the video education group received educational movie.
Also, an abstract of the educational content was provided to the participants of oral education group in writing for home use. The educational movie was provided to the participants of video education group in the form of DVDs for home use.
Participants will bewere allocated to verbal education group, video education group, and control groupgroups. The participants in the oral education group received 2four educational sessions during a two-week interval. The participants in the video education group received educational movie. Also, an abstract of the educational content was provided to the participants of oral education group in writing for home use. The educational movie was provided to the participants of video education group in the form of DVDs for home use.
شرکت کنندگان به گروه های آموزش شفاهی، آموزش ویدیویی و گروه کنترل تخصیص یافتند.شرکت کنندگان در گروه آموزش شفاهی 2 جلسه آموزشی را در طی دو هفته دریافت نمودند. شرکت کنندگان در گروه آموزش ویدیویی یک فیلم آموزشی دریافت نمودند.
شرکت کنندگان به گروه های آموزش شفاهی، آموزش ویدیویی و گروه کنترل تخصیص یافتند. شرکت کنندگان در گروه آموزش شفاهی 4 جلسه آموزشی را در طی دو هفته دریافت نمودند. شرکت کنندگان در گروه آموزش ویدیویی یک فیلم آموزشی دریافت نمودند.
همچنین، چکیده ای از محتوای آموزشی بصورت کتبی جهت استفاده خانگی شرکت کنندگان گروه آموزش شفاهی فراهم شد. فیلم آموزشی نیز در قالب دی وی دی جهت استفاده خانگی شرکت کنندگان گروه آموزش ویدیویی فراهم شد.
شرکت کنندگان به گروه های آموزش شفاهی، آموزش ویدیویی و گروه کنترل تخصیص یافتند.شرکتیافتند. شرکت کنندگان در گروه آموزش شفاهی 24 جلسه آموزشی را در طی دو هفته دریافت نمودند. شرکت کنندگان در گروه آموزش ویدیویی یک فیلم آموزشی دریافت نمودند. همچنین، چکیده ای از محتوای آموزشی بصورت کتبی جهت استفاده خانگی شرکت کنندگان گروه آموزش شفاهی فراهم شد. فیلم آموزشی نیز در قالب دی وی دی جهت استفاده خانگی شرکت کنندگان گروه آموزش ویدیویی فراهم شد.
Biochemical parameters (such as Fasting Blood Sugar (FBS), Total Cholesterol (TC) and Triglyceride Levels (TG))
Patients' weight and Biochemical parameters (such as Fasting Blood Sugar (FBS), Glycated hemoglobin (HbA1c), Total Cholesterol (TC), Triglyceride Levels (TG), low-Density Lipoprotein (LDL), and High Density Lipoprotein (HDL))
Patients' weight and Biochemical parameters (such as Fasting Blood Sugar (FBS), Glycated hemoglobin (HbA1c), Total Cholesterol (TC) and, Triglyceride Levels (TG), low-Density Lipoprotein (LDL), and High Density Lipoprotein (HDL))
متغیرهای بیوشیمیایی (از قبیل قند خون ناشتا، کلسترول تام و سطح تری گلیسرید)
وزن بیمار و متغیرهای بیوشیمیایی (از قبیل قند خون ناشتا، هموگلوبین گلیکوزیله، کلسترول تام و سطح تری گلیسرید، لیپوپروتئین با وزن مولوکولی پایین، لیپوپروتئین با وزن مولوکولی بالا)
وزن بیمار و متغیرهای بیوشیمیایی (از قبیل قند خون ناشتا، هموگلوبین گلیکوزیله، کلسترول تام و سطح تری گلیسرید، لیپوپروتئین با وزن مولوکولی پایین، لیپوپروتئین با وزن مولوکولی بالا)
General information
1
1
377
378
377378
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جزییات بیشتری اضافه شده است.
جزییات بیشتری اضافه شده است.
The Comparison of Two Education Programs on Dietary Regimen Compliance in Patients with Diabetes Mellitus
The Comparison of Two Educational Programs on Dietary Regimen Compliance in Patients with Diabetes
The Comparison of Two EducationEducational Programs on Dietary Regimen Compliance in Patients with Diabetes Mellitus
The Comparison of the Effects of Two Education Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
The Comparison of the Effects of Two Educational Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
The Comparison of the Effects of Two EducationEducational Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
The patients were assigned into the video education (n=126), control (n=126), and verbal education (n=125) groups using a random allocation method via the computer-generated random numbers.
Patients were randomized in a 1:1:1 ratio using a permuted block method with varying block sizes to video education, oral education, or control group.
The patientsPatients were assigned into the video education (n=126), control (n=126), and verbal education (n=125) groupsrandomized in a 1:1:1 ratio using a random allocationpermuted block method via the computer-generated random numberswith varying block sizes to video education, oral education, or control group.
بیماران با استفاده از جدول اعداد تصادفی کامپیوتر به گروه های آموزش ویدیویی (126 نفر)، کنترل (126 نفر) و آموزش شفاهی(125 نفر) بصورت تصادفی تخصیص یافتند.
بیماران با استفاده از روش بلوک جایگزین با اندازه های مختلف بلوک به آموزش ویدئو ، آموزش شفاهی یا گروه کنترل در نسبت 1: 1: 1 بصورت تصادفی تخصیص یافتند.
بیماران با استفاده از جدول اعداد تصادفی کامپیوترروش بلوک جایگزین با اندازه های مختلف بلوک به گروه هایآموزش ویدئو ، آموزش ویدیویی (126 نفر)،شفاهی یا گروه کنترل (126 نفر) و آموزش شفاهی(125 نفر)در نسبت 1: 1: 1 بصورت تصادفی تخصیص یافتند.
Primary outcomes
#1
2 days before the intervention were measured. The laboratory indices were measured again 45 days after the end of the intervention.
2 days before the intervention was measured. The laboratory index was measured again 90 days later.
2 days before the intervention werewas measured. The laboratory indices wereindex was measured again 4590 days after the end of the interventionlater.
از 2 روز قبل از مداخله، اندازه گیری شد. شاخص های آزمایشگاهی مجددا 45 روز بعد از مداخله اندازه گیری شدند.
از 2 روز قبل از مداخله، اندازه گیری شد. شاخص آزمایشگاهی مجددا 90 روز بعد اندازه گیری شد.
از 2 روز قبل از مداخله، اندازه گیری شد. شاخص های آزمایشگاهی مجددا 4590 روز بعد از مداخله اندازه گیری شدندشد.
After fasting for 12 hours using laboratory Kit were measured.
After fasting for 12 hours using laboratory Kit was measured.
After fasting for 12 hours using laboratory Kit werewas measured.
بعد از 12 ساعت ناشتایی با استفاده از کیت های آزمایشگاهی اندازه گیری شدند.
بعد از 12 ساعت ناشتایی با استفاده از کیت های آزمایشگاهی اندازه گیری شد.
بعد از 12 ساعت ناشتایی با استفاده از کیت های آزمایشگاهی اندازه گیری شدندشد.
#2
Triglyceride Levels (TG)
Lipid profile (TG, Cholesterol, LDL, and HDL)
Triglyceride LevelsLipid profile (TG, Cholesterol, LDL, and HDL)
سطح تری گلیسرید
پروفایل چربی (تری گلیسیرید، کلسترول، لیپوپروتئین یا وزن مولوکولی پایین و لیپوپروتئین یا وزن مولوکولی بالا)
سطح پروفایل چربی (تری گلیسریدگلیسیرید، کلسترول، لیپوپروتئین یا وزن مولوکولی پایین و لیپوپروتئین یا وزن مولوکولی بالا)
2 days before the intervention were measured. The laboratory indices were measured again 45 days after the end of the intervention.
2 days before the intervention were measured. The laboratory indices were measured again 90 days later.
2 days before the intervention were measured. The laboratory indices were measured again 4590 days after the end of the interventionlater.
از 2 روز قبل از مداخله، اندازه گیری شد. شاخص های آزمایشگاهی مجددا 45 روز بعد از مداخله اندازه گیری شدند.
از 2 روز قبل از مداخله، اندازه گیری شد. شاخص های آزمایشگاهی مجددا 90 روز بعد اندازه گیری شدند.
از 2 روز قبل از مداخله، اندازه گیری شد. شاخص های آزمایشگاهی مجددا 4590 روز بعد از مداخله اندازه گیری شدند.
#3
Total Cholesterol (TC)
Glycated hemoglobin (HbA1c)
Total CholesterolGlycated hemoglobin (TCHbA1c)
کلسترول تام
هموگلوبین گلیکوزیله
کلسترول تامهموگلوبین گلیکوزیله
2 days before the intervention were measured. The laboratory indices were measured again 45 days after the end of the intervention.
2 days before the intervention was measured. The laboratory index was measured again 90 days later.
2 days before the intervention werewas measured. The laboratory indices wereindex was measured again 4590 days after the end of the interventionlater.
از 2 روز قبل از مداخله، اندازه گیری شد. شاخص های آزمایشگاهی مجددا 45 روز بعد از مداخله اندازه گیری شدند.
از 2 روز قبل از مداخله، اندازه گیری شد. شاخص آزمایشگاهی مجددا 90 روز بعد از مداخله اندازه گیری شد.
از 2 روز قبل از مداخله، اندازه گیری شد. شاخص های آزمایشگاهی مجددا 4590 روز بعد از مداخله اندازه گیری شدندشد.
After fasting for 12 hours using laboratory Kit were measured.
After fasting for 12 hours using laboratory Kit was measured.
After fasting for 12 hours using laboratory Kit werewas measured.
بعد از 12 ساعت ناشتایی با استفاده از کیت های آزمایشگاهی اندازه گیری شدند.
بعد از 12 ساعت ناشتایی با استفاده از کیت های آزمایشگاهی اندازه گیری شد.
بعد از 12 ساعت ناشتایی با استفاده از کیت های آزمایشگاهی اندازه گیری شدندشد.
#4
empty
Patients' weight
Patients' weight
empty
وزن بیمار
وزن بیمار
empty
2 days before the intervention was measured. The patients' weight was measured again 90 days later.
2 days before the intervention was measured. The patients' weight was measured again 90 days later.
empty
از 2 روز قبل از مداخله، اندازه گیری شد. وزن بیمار مجددا 90 روز بعد اندازه گیری شد.
از 2 روز قبل از مداخله، اندازه گیری شد. وزن بیمار مجددا 90 روز بعد اندازه گیری شد.
empty
The patients' weight was measured using a digital scale.
The patients' weight was measured using a digital scale.
empty
وزن بیمار با استفاده از ترازوی دیجیتالی اندازه گیری شد.
وزن بیمار با استفاده از ترازوی دیجیتالی اندازه گیری شد.
Intervention groups
#1
First intervention group: The participants in the verbal education group received 4 educational sessions during a two-week interval. The education program was implemented in a quiet conference room. Each session was 45-minute.
First intervention group: The participants in the oral education group received 4 educational sessions during a two-week interval. The educational program was implemented in a quiet conference room. Each session was 45-minute.
First intervention group: The participants in the verbaloral education group received 4 educational sessions during a two-week interval. The educationeducational program was implemented in a quiet conference room. Each session was 45-minute.
گروه مداخله اول: شرکت کنندگان در گروه آموزش شفاهی 4 جلسه آموزشی را در طی دو هفته دریافت نمودند. برنامه آموزشی در یک سالن کنفرانس و در محیطی آرام اجرا شد. مدت زمان هر جلسه 45 دقیقه بود
گروه مداخله اول: شرکت کنندگان در گروه آموزش شفاهی 4 جلسه آموزشی را در طی دو هفته دریافت نمودند. برنامه آموزشی در یک سالن کنفرانس و در محیطی آرام اجرا شد. مدت زمان هر جلسه 45 دقیقه بود.
گروه مداخله اول: شرکت کنندگان در گروه آموزش شفاهی 4 جلسه آموزشی را در طی دو هفته دریافت نمودند. برنامه آموزشی در یک سالن کنفرانس و در محیطی آرام اجرا شد. مدت زمان هر جلسه 45 دقیقه بود.
#2
Control group: The participants in the control group received routine care by clinical nurses.
Control group: The participants in the control group received routine care and a educational pamphlet by clinical nurses.
Control group: The participants in the control group received routine care and a educational pamphlet by clinical nurses.
گروه کنترل: شرکت کنندگان در گروه کنترل مراقبت های معمول را توسط پرستاران بالینی دریافت نمودند.
گروه کنترل: شرکت کنندگان در گروه کنترل مراقبت های معمول و یک پمفلت آموزشی را توسط پرستاران بالینی دریافت نمودند.
گروه کنترل: شرکت کنندگان در گروه کنترل مراقبت های معمول و یک پمفلت آموزشی را توسط پرستاران بالینی دریافت نمودند.
Protocol summary
Study aim
The Comparison of the Effects of Two Educational Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
Design
Three parallel group randomized trial which 378 patients participated.
Settings and conduct
This study was performed in the diabetic clinic affiliated to Ahvaz University of Medical Sciences. Participants were allocated to oral education group, video education group and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria to the study: Eighteen years or older; being able to spoke in Farsi or Arabic.
Exclusion criteria to the study: Having other chronic diseases; having visual, hearing, and speech impairments; being pregnant.
Intervention groups
Participants were allocated to verbal education, video education, and control groups. The participants in the oral education group received four educational sessions during a two-week interval. The participants in the video education group received educational movie.
Also, an abstract of the educational content was provided to the participants of oral education group in writing for home use. The educational movie was provided to the participants of video education group in the form of DVDs for home use.
Main outcome variables
Patients' weight and Biochemical parameters (such as Fasting Blood Sugar (FBS), Glycated hemoglobin (HbA1c), Total Cholesterol (TC), Triglyceride Levels (TG), low-Density Lipoprotein (LDL), and High Density Lipoprotein (HDL))
General information
Reason for update
Added more details.
Acronym
IRCT registration information
IRCT registration number:IRCT20150302021307N4
Registration date:2020-03-24, 1399/01/05
Registration timing:retrospective
Last update:2021-03-24, 1400/01/04
Update count:2
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
Mojtaba Miladinia
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 613333333
Email address
miladinia.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-17, 1398/11/28
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
2020-02-17, 1398/11/28
Actual recruitment end date
2020-03-05, 1398/12/15
Trial completion date
2020-03-10, 1398/12/20
Scientific title
The Comparison of the Effects of Two Educational Programs on Dietary Regimen Compliance in Patients with Type 2 Diabetes Mellitus
Public title
The Comparison of Two Educational Programs on Dietary Regimen Compliance in Patients with Diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Eighteen years or older
Being able to spoke in Farsi or Arabic
Exclusion criteria:
Having other chronic diseases
Having visual, hearing, and speech impairments
Being pregnant
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
378
Actual sample size reached:
364
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized in a 1:1:1 ratio using a permuted block method with varying block sizes to video education, oral education, or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyzer and those assessing the outcomes were blinded. we gave a code to the each study group and they did not know each patient was in which groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Science
Street address
Research center, Golestan Blv
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.AJUMS.REC.1398.901
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E 11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Fasting blood sugar (FBS)
Timepoint
2 days before the intervention was measured. The laboratory index was measured again 90 days later.
Method of measurement
After fasting for 12 hours using laboratory Kit was measured.
2
Description
Lipid profile (TG, Cholesterol, LDL, and HDL)
Timepoint
2 days before the intervention were measured. The laboratory indices were measured again 90 days later.
Method of measurement
After fasting for 12 hours using laboratory Kit were measured.
3
Description
Glycated hemoglobin (HbA1c)
Timepoint
2 days before the intervention was measured. The laboratory index was measured again 90 days later.
Method of measurement
After fasting for 12 hours using laboratory Kit was measured.
4
Description
Patients' weight
Timepoint
2 days before the intervention was measured. The patients' weight was measured again 90 days later.
Method of measurement
The patients' weight was measured using a digital scale.
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: The participants in the oral education group received 4 educational sessions during a two-week interval. The educational program was implemented in a quiet conference room. Each session was 45-minute.
Category
Lifestyle
2
Description
Second intervention group: The participants in the video education group received educational movie. The educational movie was displayed in two sessions during a two-week interval. The total movie length was two hours.
Category
Lifestyle
3
Description
Control group: The participants in the control group received routine care and a educational pamphlet by clinical nurses.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetic clinic affiliated to Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Molavynejad
Street address
Ahvaz University of Medical Sciences., Esfand Ave., Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3731 1111
Email
shahrambaraz@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mr Mohammad Badavi
Street address
Research center, University of Medical Science, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3731 1111
Email
shahrambaraz@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
Mojtaba Miladinia
Position
Instructor of faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing faculty, University of Medical Science, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
11111111
Phone
+98 613333333
Fax
Email
miladinia.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojtaba Miladinia
Position
Instructor of faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing faculty, University of Medical Science, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
11111111
Phone
+98 613333333
Fax
+98 61 3333 3333
Email
miladinia.m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing faculty, University of Medical Science, Golestan Blv, Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
111111111
Phone
+98 61 3373 8333
Fax
Email
shahrambaraz@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
The data file will be subscribed to by the SPSS software format. Only the original outcome can be shared.
When the data will become available and for how long
The start of the access period is 12 months after the publication of the results and for 3 months.
To whom data/document is available
Data will only be available to researchers working in academia.
Under which criteria data/document could be used
Data will only be available for use in review and meta-analyzes studies.
What processes are involved for a request to access data/document
First, send an e-mail to the author and mention the purpose of obtaining the information. In the absence of a problem, you will receive information one to three weeks later.