Evaluating the effects of correcting time of eating breakfast on insulin resistance markers, dietary intakes and anthropometric indices, and mental health in overweight and obese people
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Protocol summary
فرد دارای اضافه وزن و چاق که شرایط ورود به مطالعه را داشته باشد در درمانگاه امام رضا و مراکز بهداشتی بر اساس جنس به دو گروه ۳۲ نفره تقسیم خواهند گردید. روند مداخله بدین صورت خواهد بود که به مدت ۲ ماه برای گروه مداخله، زمان صبحانه تغییر خواهد کرد به این صورت که به افراد گفته می شود صبحانه خود را تا قبل از ساعت ۹ صبح دریافت نمایند و گروه کنترل به همان روند قبلی خود ادامه خواهند داد. کلیه پرسشنامه ها در ابتدا و انتهای مطالعه تکمیل خواهد شد.
فرد دارای اضافه وزن و چاق که شرایط ورود به مطالعه را داشته باشد در درمانگاه امام رضا و مراکز بهداشتی بر اساس جنس به دو گروه ۳۲ نفره تقسیم خواهند گردید.روند مداخله بدین صورت خواهد بود که به مدت ۲ ماه برای گروه مداخله علاوه بر رژیم غذایی کاهش وزن(کسر500کیلوکالری) زمان صبحانه تغییر خواهد کرد افراد صبحانه خود را تا قبل از ساعت ۹ صبح دریافت نمایند و گروه کنترل فقط رژیم غذایی کاهش وزن(کسر 500 کیلوکالری) دریافت خواهند کرد.
فرد دارای اضافه وزن و چاق که شرایط ورود به مطالعه را داشته باشد در درمانگاه امام رضا و مراکز بهداشتی بر اساس جنس به دو گروه ۳۲ نفره تقسیم خواهند گردید. روندگردید.روند مداخله بدین صورت خواهد بود که به مدت ۲ ماه برای گروه مداخله، علاوه بر رژیم غذایی کاهش وزن(کسر500کیلوکالری) زمان صبحانه تغییر خواهد کرد به این صورت که به افراد گفته می شود صبحانه خود را تا قبل از ساعت ۹ صبح دریافت نمایند و گروه کنترل به همان روند قبلی خود ادامهفقط رژیم غذایی کاهش وزن(کسر 500 کیلوکالری) دریافت خواهند دادکرد. کلیه پرسشنامه ها در ابتدا و انتهای مطالعه تکمیل خواهد شد.
Intervention groups
#1
Intervention group: The intervention will be such that for 2 months for the intervention group, the breakfast time will be changed in such a way that the individuals is said that they will receive their breakfast before 9 am and the control group will continue with their previous process.
Intervention group: The intervention process will be such that for 2 months for the intervention group, in addition to the weight loss diet (500 kilocalorie deficit), the breakfast time will be changed in such a way that people will be told to have their breakfast before 9 am and the group Controls will only receive a weight loss diet (500 kcal deficit).
Intervention group: The intervention process will be such that for 2 months for the intervention group, in addition to the weight loss diet (500 kilocalorie deficit), the breakfast time will be changed in such a way that the individuals is said that theypeople will receivebe told to have their breakfast before 9 am and the control group Controls will continue with their previous processonly receive a weight loss diet (500 kcal deficit).
گروه مداخله: مداخله بدین صورت خواهد بود که به مدت ۲ ماه برای گروه مداخله، زمان صبحانه تغییر خواهد کرد به این صورت که به افرادگفته می شود صبحانه خود را تا قبل از ساعت ۹ صبح دریافت نمایند و گروه کنترل به همان روند قبلی خود ادامه خواهند داد.
گروه مداخله: روند مداخله بدین صورت خواهد بود که به مدت ۲ ماه برای گروه مداخله علاوه بر رژیم غذایی کاهش وزن(کسر500کیلوکالری) زمان صبحانه تغییر خواهد کرد به این صورت که به افراد گفته می شود صبحانه خود را تا قبل از ساعت ۹ صبح دریافت نمایند و گروه کنترل فقط رژیم غذایی کاهش وزن(کسر 500 کیلوکالری) دریافت خواهند کرد.
گروه مداخله: روند مداخله بدین صورت خواهد بود که به مدت ۲ ماه برای گروه مداخله، علاوه بر رژیم غذایی کاهش وزن(کسر500کیلوکالری) زمان صبحانه تغییر خواهد کرد به این صورت که به افرادگفتهافراد گفته می شود صبحانه خود را تا قبل از ساعت ۹ صبح دریافت نمایند و گروه کنترل به همان روند قبلی خود ادامهفقط رژیم غذایی کاهش وزن(کسر 500 کیلوکالری) دریافت خواهند دادکرد.
Recruitment centers
#1
Name of recruitment center - English: Imam Reza Clinic
Name of recruitment center - Persian: درمانگاه امام رضا
Full name of responsible person - English: Saeedeh jalali
Full name of responsible person - Persian: سعیده جلالی
Street address - English: Shiraz, Namazi Square, next to Namazi Hospital, Imam Reza (a.s.) special specialized and sub-specialized clinic
Street address - Persian: شیراز، میدان نمازی، جنب بیمارستان نمازی، کلینیک ویژه تخصصی و فوق تخصصی امام رضا(ع)
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 71348-14734
Phone: +98 71 3212 7000
Fax:
Email: motahari@sums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza Clinic
Name of recruitment center - Persian: درمانگاه امام رضا
Full name of responsible person - English: Saeedeh jalali
Full name of responsible person - Persian: سعیده جلالی
Street address - English: Imam Reza special specialized and sub-specialized clinic, 19 / 5,000 Translation results Translation result Next to Namazi Hospital, Namazi Square, Shiraz
Street address - Persian: شیراز، میدان نمازی، جنب بیمارستان نمازی، کلینیک ویژه تخصصی و فوق تخصصی امام رضا(ع)
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 71348-14734
Phone: +98 71 3212 7000
Fax:
Email: motahari@sums.ac.ir
Web page address:
Name of recruitment center - English: Imam Reza Clinic Name of recruitment center - Persian: درمانگاه امام رضا Full name of responsible person - English: Saeedeh jalali Full name of responsible person - Persian: سعیده جلالی Street address - English: Shiraz, Namazi Square, next to Namazi Hospital, Imam Reza (a.s.) special specialized and sub-specialized clinic, 19 / 5,000 Translation results Translation result Next to Namazi Hospital, Namazi Square, Shiraz Street address - Persian: شیراز، میدان نمازی، جنب بیمارستان نمازی، کلینیک ویژه تخصصی و فوق تخصصی امام رضا(ع) City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 71348-14734 Phone: +98 71 3212 7000 Fax: Email: motahari@sums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Hashem Hashempour
Full name of responsible person - Persian: دکتر محمدهاشم هاشم پور
Street address - English: Shiraz, Zand Street, Shiraz University of Medical Sciences Central Building, 7th Floor, Research and Technology Deputy
Street address - Persian: شیراز،خیابان زند،ساختمان مرکزی دانشگاه علوم پزشکی شیراز،طبقه هفتم،معاونت تحقیقات و فناوری
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 71947-33669
Phone: +98 71 3235 7282
Fax:
Email: vcrdep@sums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Hashem Hashempour
Full name of responsible person - Persian: دکتر محمدهاشم هاشم پور
Street address - English: Research and Technology Deputy, 7th Floor, Shiraz University of Medical Sciences Central Building, Zand Street, Shiraz Town
Street address - Persian: شیراز، خیابان زند، ساختمان مرکزی دانشگاه علوم پزشکی شیراز، طبقه هفتم، معاونت تحقیقات و فناوری
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 71947-33669
Phone: +98 71 3235 7282
Fax:
Email: vcrdep@sums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Mohammad Hashem Hashempour Full name of responsible person - Persian: دکتر محمدهاشم هاشم پور Street address - English: ShirazResearch and Technology Deputy, Zand Street7th Floor, Shiraz University of Medical Sciences Central Building, 7th FloorZand Street, Research and Technology DeputyShiraz Town Street address - Persian: شیراز،خیابان زند،ساختمان مرکزی دانشگاه علوم پزشکی شیراز،طبقه هفتم،معاونت تحقیقات و فناوری City - English: Shiraz City - Persian: شیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 71947-33669 Phone: +98 71 3235 7282 Fax: Email: vcrdep@sums.ac.ir Web page address:
Protocol summary
Study aim
Determining the effects of correcting time of eating breakfast on insulin resistance markers, dietary intakes and
anthropometric indices, and mental health in overweight and obese people
Design
Clinical trial with control group, with parallel group, no blinding, randomized on 64
Settings and conduct
Overweight and obese person
Two groups of 32 people
Change of breakfast time for two months for intervention group
Participants/Inclusion and exclusion criteria
Inclusion criteria: healthy women and men between 18 and 50 years old, with a body mass index greater than 25 and constant weight ≤ 5% change in 6 months be past and have a desire to participate in the study. have an inappropriate time to eat
Exclusion criteria: Disturbances in the circadian rhythm or sleep, having shift work, using sleeping pills, using medications that affect weight or sleep, major depression, eating disorders such as ≥5% weight loss or gain during 6 Previous month; previous bariatric surgery, having special diets and eating normally in a tight time window in the past year; Any type of illness and condition that affects the timing of meals. Pregnancy, breastfeeding, or other conditions that can contribute Disrupt study.
Intervention groups
Intervention group: Healthy women and men between 18 and 50 years of age, with a body mass index greater than 25 and constant weight ≤5% change in 6 months have passed and want to participate in the study,
Have an inappropriate time to eat.
Control group: Healthy women and men between 18 and 50 years of age, with a body mass index greater than 25 and constant weight ≤5% change in 6 months have passed and want to participate in the study, Have an inappropriate time to eat.
Evaluating the effects of correcting time of eating breakfast on insulin resistance markers, dietary intakes and anthropometric indices, and mental health in overweight and obese people
Public title
The effects of correcting time of eating breakfast in overweight and obese people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy men and women between 18 and 50 years old
Body mass index is more than 25 and stable weight ≤ 5% change in the last 6 months
Have an inappropriate time to eat
Willingness to participate in the study
Exclusion criteria:
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be allocated between two intervention and control groups using the balanced block randomization method. Allocation concealment will also be done in this plan. The method of concealing the allocation of participants (the mechanism used in randomizing the allocation of participants (such as sequentially numbered containers) and explaining all the actions that can be taken to hide the sequence until the intervention is allocated to each group) randomization is done by a third person and When the person comes and we get the basic information from the person, we call the third person and ask him which group this person belongs to.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No. 189, Corner of West hedayat Ave, Haft tir Blvd, Shiraz Town
City
shiraz
Province
Fars
Postal code
7134794859
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.056
Health conditions studied
1
Description of health condition studied
Overweight and obese people
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Weight
Timepoint
At the beginning of the study and after 60 days from the start of the study
Method of measurement
Scales
2
Description
Height
Timepoint
At the beginning of the study and after 60 days from the start of the study
Method of measurement
Meters
3
Description
Waist
Timepoint
At the beginning of the study and after 60 days from the start of the study
Method of measurement
Meters
Secondary outcomes
1
Description
Insulin resistance
Timepoint
The beginning of the study and the end of 60 days
Method of measurement
Insulin kit and sugar kit
2
Description
Mental health
Timepoint
The beginning of the study and the end of 60 days
Method of measurement
Dass-21 questionary
Intervention groups
1
Description
Intervention group: The intervention process will be such that for 2 months for the intervention group, in addition to the weight loss diet (500 kilocalorie deficit), the breakfast time will be changed in such a way that people will be told to have their breakfast before 9 am and the group Controls will only receive a weight loss diet (500 kcal deficit).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Saeedeh jalali
Street address
Imam Reza special specialized and sub-specialized clinic, 19 / 5,000 Translation results Translation result Next to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14734
Phone
+98 71 3212 7000
Email
motahari@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Research and Technology Deputy, 7th Floor, Shiraz University of Medical Sciences Central Building, Zand Street, Shiraz Town
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
saeedeh jalali
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 189, Corner of West hedayat Ave, Haft tir Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7134794859
Phone
+98 71 3725 1001
Email
saeedeh.jalaliii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
saeedeh jalali
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 189, Corner of West hedayat Ave, Haft tir Blvd, Shiraz Town
City
shiraz
Province
Fars
Postal code
7134794859
Phone
+98 71 3725 1001
Email
saeedeh.jalaliii@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
saeedeh jalali
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No. 189, Corner of West hedayat Ave, Haft tir Blvd, Shiraz Town
City
Shiraz
Province
Fars
Postal code
7134794859
Phone
+98 71 3725 1001
Email
saeedeh.jalaliii@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available