Protocol summary
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Study aim
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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
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Design
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Clinical trial with control group, with parallel group, no blinding, randomized on 64
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Settings and conduct
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Overweight and obese person
Two groups of 32 people
Change of breakfast time for two months for intervention group
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Insulin resistance, mental health, appetite score, weight, waist circumference
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231028059876N1
Registration date:
2023-11-18, 1402/08/27
Registration timing:
prospective
Last update:
2024-04-11, 1403/01/23
Update count:
1
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Registration date
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2023-11-18, 1402/08/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-22, 1402/09/01
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Expected recruitment end date
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2024-04-20, 1403/02/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effects of correcting time of eating breakfast in overweight and obese people
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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:
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-05-28, 1402/03/07
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Ethics committee reference number
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IR.SUMS.SCHEANUT.REC.1402.056
Health conditions studied
1
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Description of health condition studied
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Overweight and obese people
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Weight
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Timepoint
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At the beginning of the study and after 60 days from the start of the study
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Method of measurement
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Scales
2
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Description
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Height
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Timepoint
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At the beginning of the study and after 60 days from the start of the study
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Method of measurement
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Meters
3
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Description
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Waist
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Timepoint
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At the beginning of the study and after 60 days from the start of the study
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Method of measurement
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Meters
Secondary outcomes
1
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Description
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Insulin resistance
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Timepoint
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The beginning of the study and the end of 60 days
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Method of measurement
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Insulin kit and sugar kit
2
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Description
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Mental health
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Timepoint
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The beginning of the study and the end of 60 days
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Method of measurement
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Dass-21 questionary
Intervention groups
1
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Description
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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).
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available