Protocol summary
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Study aim
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To assess the effect of education of participation care versus no education on the control of blood glucose and lifestyle in women with gestational diabetes
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Design
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This is a randomized clinical trial, phase II, in which 80 eligible patients will be randomly assigned to the intervention and control groups using a block randomization.
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Settings and conduct
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The eligible women with gestational diabetes who will refer to Healthcare Centers of Hamadan City during the study period will be enrolled into the trial
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age of 18 to 40 years
Gestational diabetes
Gestational age of 6 to 10 weeks
Literate
Exclusion criteria:
Cognitive disorder
Mental disorder
Inability or contraindication of physical activity
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Intervention groups
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Intervention group: Routine cares plus 5 educational sessions of participation care once a week in 45 to 60 minutes sessions
Control group: Just routine cares
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Main outcome variables
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Primary outcome: (a) Assessing fasting blood sugar before intervention and 5 weeks after that through laboratory testing; (b) Assessing lifestyle before intervention and 5 weeks after that using Walker standard questionnaire
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:
IRCT20120215009014N203
Registration date:
2018-01-19, 1396/10/29
Registration timing:
prospective
Last update:
2018-02-14, 1396/11/25
Update count:
1
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Registration date
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2018-01-19, 1396/10/29
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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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2018-01-30, 1396/11/10
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Expected recruitment end date
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2019-01-30, 1397/11/10
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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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Effect of education of participation care versus no education on the control of blood glucose and lifestyle in women with gestational diabetes: a randomized clinical trial
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Public title
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Effect of education of participation care versus no education on the control of blood glucose and lifestyle in women with gestational diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 18 to 40 years
Gestational diabetes
Gestational age of 6 to 10 weeks
Literate
Exclusion criteria:
Cognitive disorder
Mental disorder
Inability or contraindication of physical activity
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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2
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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:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients will be randomly assigned to intervention and control groups using block randomization.
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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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2018-01-13, 1396/10/23
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Ethics committee reference number
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Ethic code: IR.UMSHA.REC.1396.720
Health conditions studied
1
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Description of health condition studied
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Gestational diabetes
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ICD-10 code
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O24.4
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ICD-10 code description
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Gestational diabetes mellitus
Primary outcomes
1
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Description
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Assessing fasting blood sugar
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Timepoint
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Before intervention and 5 weeks after that
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Method of measurement
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Through laboratory testing
2
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Description
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Assessing lifestyle
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Timepoint
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Before intervention and 5 weeks after that
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Method of measurement
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Using Walker standard questionnaire
Intervention groups
1
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Description
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Intervention group: Routine cares plus 5 educational sessions of participation care once a week in 45 to 60 minutes sessions
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Category
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Other
2
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Description
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Control group: Just routine cares
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Category
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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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Hamedan 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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Not applicable
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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