Protocol summary
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Study aim
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reduce the incidence of gestational diabetes
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Design
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Based on random numbers, the final sample size was 132 people (66 in the control group and 66 in the intervention group)
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Settings and conduct
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4 Counselling sessions: 1- Understanding the goals, rules of the group 2- Expressing the feelings of the patients about the change, teaching the appropriate physical activities in pregnancy
3. Dietary education in pregnancy 4. Stress management training and interpersonal communication,
5. Understanding temptation situations, training spiritual growth and accountability, summing up and summing up previous session exercises.
The place of intervention is in the classroom at Rouhani Hospital.
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Participants/Inclusion and exclusion criteria
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inclusion criteria; normal fasting blood shouger, age more than 16 years, BMI => 25 reading and writing literacy, single pregnancy and gestational age between 12 weeks and 1 day to 16 weeks and 6 days.
Exclusion criteria include disorders such as the diagnosis of pre-pregnancy blood pressure, diabetes, kidney disease, lupus, anti-phospholipid syndrome, tuberculosis, anemia, thalassemia, intestinal colic, thyroid disorders and neurological disorders.
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Intervention groups
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counseling based on health promoting behaviors
standard pregnancy care
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Main outcome variables
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mean scores of fasting glucose and glucose tolerance test, mean scores of health promotion behaviors, psychological well-being.
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:
IRCT20120125008822N3
Registration date:
2018-07-05, 1397/04/14
Registration timing:
prospective
Last update:
2019-08-17, 1398/05/26
Update count:
1
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Registration date
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2018-07-05, 1397/04/14
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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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2018-07-23, 1397/05/01
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Expected recruitment end date
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2019-03-01, 1397/12/10
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Actual recruitment start date
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2018-07-23, 1397/05/01
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Actual recruitment end date
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2019-02-09, 1397/11/20
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Trial completion date
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2019-04-09, 1398/01/20
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Scientific title
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Comparison of the effectiveness of counseling based on health promoting behaviors on fasting blood glucose and glucose tolerance test in pregnant and overweight and obese women
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Public title
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The effect of counseling based on health-promoting behaviors on fasting blood glucose control and glucose tolerance test
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
pregnant women with gestational age 12 -16 weeks and body mass index >=25
Exclusion criteria:
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Age
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From 16 years old
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Gender
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Female
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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:
132
Actual sample size reached:
148
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Initially, eligible pregnancies are selected from pregnant women referred to the pregnancy clinic of the Educational and Therapeutic Babol Rohani Hospital and then divided into two intervention and control groups according to the random numbers table.
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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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2018-06-10, 1397/03/20
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Ethics committee reference number
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IR.MUBABOL.HRI.REC.1397.068
Health conditions studied
1
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Description of health condition studied
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Diabetes mellitus in pregnancy
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ICD-10 code
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024
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ICD-10 code description
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Diabetes mellitus in pregnancy
Primary outcomes
1
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Description
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mean of fasting blood glucose-glucose tolerance test
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Timepoint
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First between 12 to 16 weeks of pregnancy and then between 26 to 28 weeks of gestational
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Method of measurement
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Laboratory measurement
Secondary outcomes
1
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Description
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Comparison of the mean of heath promotion behaviors in overweight and obese pregnant women
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Timepoint
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The first between 12 to 16 and then between 26 to 28 gestational
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Method of measurement
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Questionnaire
2
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Description
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Mean scores of psychological well-being in over weight and obese pregnant women
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Timepoint
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At first between 12 to 16 weeks and then between 26 to 28 gestational
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: The Impact of counseling based on health promoting behaviors
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Category
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Lifestyle
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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Babol 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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No - There is not a plan to make this available