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The effect of health coach program based on midwifery counselor on self-care behavior in women with gestational diabetes

Protocol summary

Study aim
The effect of health coach program based on midwifery counselor on self-care behavior in women with gestational diabetes
Design
Intervention Group: 4 sessions per week, 1 session 60-minute, group and face-to-face, and 4 sessions per person per person. At the end of the 4 interventions sessions, 4 weeks follow up, the questionnaires and blood glucose level in the intervention group will be completed to follow up. Control group: In the control group, after 4 weeks after completion the primary questionnaires, the questionnaires and blood sugar level will be completed again.
Settings and conduct
4 sessions per week, 1 session 60-minute, group and face-to-face, and 4 sessions per person per person. At the end of the 4 interventions sessions, 4 weeks follow up, the questionnaires and blood glucose level in the intervention group will be completed to follow up. In the control group, after 4 weeks after completion the primary questionnaires, the questionnaires and blood sugar level will be completed again.The study will be performed in the waiting room at the prenatal ward of the Razi Hospital in Qaemshahr.
Participants/Inclusion and exclusion criteria
58 women with gestational diabetes. inclusion criteria: Maternal gestational age 24-28 weeks. Exclusion Criteria: unwillingness to Continuation of research.
Intervention groups
Intervention Group: 4 sessions per week, 1 session 60-minute, group and face-to-face, and 4 sessions per person per person. At the end of the 4 interventions sessions, 4 weeks follow up, the questionnaires and blood glucose level in the intervention group will be completed to follow up. Control group: In the control group, after 4 weeks after completion the primary questionnaires, the questionnaires and blood sugar level will be completed again.
Main outcome variables
Perceived stress؛ self-care behavior؛ blood glucose

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110827007422N2
Registration date: 2019-04-11, 1398/01/22
Registration timing: registered_while_recruiting

Last update: 2019-04-11, 1398/01/22
Update count: 0
Registration date
2019-04-11, 1398/01/22
Registrant information
Name
Zhila Ganji
Name of organization / entity
Mazandaran University of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
zhila.ganji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-03, 1398/01/14
Expected recruitment end date
2019-05-04, 1398/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of health coach program based on midwifery counselor on self-care behavior in women with gestational diabetes
Public title
The effect of health coach program based on midwifery counselor on self-care behavior in women with gestational diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Maternal gestational age 24-28 weeks reading and writing skills lack of addiction to drugs such as psychotropic substances and stimulants, alcoholic beverages, cigarettes and hookahs no history of medical illness (diabetes, heart disease, respiratory, kidney, thyroid disorders, Epilepsy, blood pressure, anemia and orthodox constraints) no history of high risk pregnancy (pregnancy poisoning, abnormal bleeding, placenta and twin pregnancy) no history of admission to psychiatry and psychiatric use
Exclusion criteria:
Unwillingness to continue to study absenteeism at each educational session occurrence of pregnancy-related complications major stressful events during the study (serious illness of the spouse and child, death of one of the loved ones, accident)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
In order not to allow all individuals to intervene or control in succession in a group, we will insert the 5 envelopes of the intervention card and 5 cards into the envelope so that the individuals are randomly assigned to the two groups and after the first 10 were identified, the next 10 The same will be selected to complete the samples.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Diabetes Research Center, Mazandaran University of Medical Sciences
Street address
Vesal shirazi street
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2018-12-14, 1397/09/23
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.056

Health conditions studied

1

Description of health condition studied
Gestational Diabetes Melitus
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified

Primary outcomes

1

Description
self-care behavior Score
Timepoint
1 month
Method of measurement
Questionnaire

2

Description
Perceived stress Score
Timepoint
1 month
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Self-care behavior Score
Timepoint
1 Month
Method of measurement
Self-Care Gestational Diabetes Questionnaire

Intervention groups

1

Description
Intervention group: The training program will be performed in 4 sessions, each week 1 session in 60 minutes in group sessions and 4 telephone sessions for each person.
Category
Prevention

2

Description
Control group:The control group will not receive any education.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaemshahr, Razi Hospital
Full name of responsible person
Jila Gangi
Street address
Vesal shirazi street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
Email
zhila.ganji@yahoo.com

2

Recruitment center
Name of recruitment center
Ghaemshahr, Razi Hospital
Full name of responsible person
Jila Gangi
Street address
Vesal shirazi street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Fax
Email
zhila.ganji@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Akbar HedayatizadehOmran
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sience
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
Akbar-hedayati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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

2

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Akbar Hedayatizadeh Omran
Street address
Deputy of Research and Technology of Mazandaran University of Medical Sience
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
Akbar-hedayati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Sedigheh Hasanimoghadam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vesal Shirazi Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
s.hasanimoghadam@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Jila Ganji
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Vesal Shirazi Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
zhila.ganji@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sedigheh Hasani moghadam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Vesal Shirazi Street
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7342
Email
s.hasanimoghadam@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
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