Protocol summary
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Study aim
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Determination and comparison of the effects of low calorie diet alone and combined with Yoga training on basal metabolic rate, Anthropomentric indices, and Adiponection and Leptin
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Design
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In this study, 36 overweight and obese women who are eligible for inclusion criteria of the study are selected, and the participants are divided into two groups of diet and yoga, with each participant assigned a code.
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Settings and conduct
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The target group is overweight and obese women who are randomly assigned into two groups of diet alone and combined with Yoga and followed for 2 months. In diet group, 500 Kilo-calorie will be reduced after calculating the individual's energy requirement and in the yoga and diet group, 7 days workshop will be done and after that Hatta Yoga will be performed every day under the supervision of coach. In this group, a 300 Kilo-calorie reduced diet, and 200 calories from the yoga exercise will be designed. Through an indirect calorie meter, the duration of the yoga will be determined to find 200 Kilo-calorie expenditure.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: overweight and obese women, age range between 30 and 55 years old
Exclusion criteria: diabetes, hypertension, and coronary heart disease, thyroid disorders, using dietary supplements that have effect on metabolism, smoking.
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Intervention groups
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intervention group: Yoga and diet
control group: diet
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Main outcome variables
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Basal metabolic rate, Anthropometric Indices, Leptin, Adiponectin
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:
IRCT20140107016123N12
Registration date:
2018-01-22, 1396/11/02
Registration timing:
retrospective
Last update:
2018-01-22, 1396/11/02
Update count:
1
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Registration date
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2018-01-22, 1396/11/02
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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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2017-12-10, 1396/09/19
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Expected recruitment end date
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2017-12-30, 1396/10/09
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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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Comparison of Low Calorie Diet alone and combined with Yoga training on basal metabolic,Anthropometric indices, Adiponectin and Leptin in Overweight and Obese Women
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Public title
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Comparison of Diet with Yoga accompanying Diet on body Metabolism in 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:
age30-55
Female
25<BMI
Failure to follow a continuous exercise program
Lack of Pregnancy, lactation and menopause
Lack of Hypertension, Diabetes, Coronary artery Disease, stroke, thyroid disorders, Mental disorders
Lack of weight loss over 5% in the last 6 months
Failure to follow a special Diet plan
Non-use of statin drugs, beta-blockers, fluorescent Drugs
Lack of unhealthy weight
Exclusion criteria:
Smoking and And tobacco
Eating any supplement that has an Effect on the Metabolism
Failure to follow the plan
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Age
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From 30 years old to 55 years old
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Gender
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Female
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Phase
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3
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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:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will done using 6 subjects per block. Statistical software (Minitab) will use to perform randomized block. For the nature of intervention (Yoga+diet and diet), blinding will not perform.
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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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Not 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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2017-11-24, 1396/09/03
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Ethics committee reference number
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IR.AJUMS.REC.1396.735
Health conditions studied
1
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Description of health condition studied
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Obesity
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ICD-10 code
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E66.0
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ICD-10 code description
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0besity due to excesscalories
Primary outcomes
1
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Description
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Basal Metabolic Rate
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Timepoint
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Before and after intervention
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Method of measurement
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Indirect calorie meter
2
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Description
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Leptin
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Timepoint
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Before and after intervention
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Method of measurement
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enzyme-linked immunosorbent assay (ELISA)
3
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Description
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Adiponectin
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Timepoint
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Before and after intervention
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Method of measurement
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enzyme-linked immunosorbent assay (ELISA)
Intervention groups
1
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Description
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Intervention group: Yoga and diet
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Category
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Treatment - Other
2
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Description
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Control group: Diet
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Category
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Treatment - Other
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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Ahvaz Jundishapur 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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Yes - There is 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
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Title and more details about the data/document
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A part of data will be able to share
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When the data will become available and for how long
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From 2019
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To whom data/document is available
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Researchers in universities
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Under which criteria data/document could be used
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Only for personal studying, not sharing
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From where data/document is obtainable
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via email: jafarirad-s@ajums.ac.ir
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What processes are involved for a request to access data/document
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a valid confirmation letter form university which the researcher works in it and then must be confirmed by Ahvaz Jundishapur University of Medical Sciences
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Comments
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