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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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History
# Registration date Revision Id
2 2019-08-16, 1398/05/25 100572
1 2018-07-05, 1397/04/14 51574
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  • Protocol summary

    5 motivational interview 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.
    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.
    5 جلسه مصاحبه انگیزشی: 1-آشنایی با اهداف، قوانین گروه 2- بیان احساسات مراجعین در خصوص تغییر، آموزش فعالیتهای فیزیکی مناسب در بارداری 3-آموزش رژیم غذایی در بارداری 4- آموزش مدیریت استرس و ارتباط بین فردی، 5-شناخت موقعیتهای وسوسه کننده، اموزش رشد معنوی و مسولیت پذیری، خلاصه و جمع بندي تمرينهاي جلسات قبلي . محل انجام مداخلات در کلاس آموزشی واقع در بیمارستان روحانی است.
    4 جلسه مشاوره: 1-آشنایی با اهداف، قوانین گروه 2- بیان احساسات مراجعین در خصوص تغییر، آموزش فعالیتهای فیزیکی مناسب در بارداری 3-آموزش رژیم غذایی در بارداری 4- آموزش مدیریت استرس و ارتباط بین فردی، 5-شناخت موقعیتهای وسوسه کننده، اموزش رشد معنوی و مسولیت پذیری، خلاصه و جمع بندي تمرينهاي جلسات قبلي . محل انجام مداخلات در کلاس آموزشی واقع در بیمارستان روحانی است.
    Group Motivational Interview standard pregnancy care
    counseling based on health promoting behaviors standard pregnancy care
    مصاحبه انگیزشی گروهی مراقبت های استاندارد بارداری
    مشاوره مبتنی بر رفتارهای ارتقا دهنده سلامت مراقبت های استاندارد بارداری
    Dependent variables: mean scores of fasting glucose and glucose tolerance test, mean scores of health promotion behaviors, psychological well-being. Independent Variables: Group Motivational Interview on the Intervention of Health Promoting Behaviors Other variables: age, body mass index, ethnicity, education, occupation, family income status, number of pregnancies
    mean scores of fasting glucose and glucose tolerance test, mean scores of health promotion behaviors, psychological well-being.
    متغییر های وابسته: میانگین گلوکز ناشتا و تست تحمل گلوکز، میانگین نمرات رفتارهای ارتقاء دهنده سلامت، بهزیستی روانی متغییر های مستقل: مصاحبه انگیزشی گروهی در مورد مداخله رفتارهای ارتقاء دهنده سلامت سایر متغییر ها: سن، شاخص توده بدن، قومیت، تحصیلات، شغل ، وضعیت درآمد خانواده، تعدادحاملگی
    میانگین گلوکز ناشتا و تست تحمل گلوکز، میانگین نمرات رفتارهای ارتقاء دهنده سلامت، بهزیستی روانی

  • General information

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    148
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    2018-07-23, 1397/05/01
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    2019-02-09, 1397/11/20
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    2019-04-09, 1398/01/20
    The impact of group motivation interview on health promotion behaviors psychological well-being and gestational diabetes mellitus in over weight pregnant women
    The effect of counseling based on health-promoting behaviors on fasting blood glucose control and glucose tolerance test
    تاثیر مصاحبه انگیرشی گروهی مبتنی بر رفتارهای ارتقا دهنده سلامت بر میانگین قند خون ناشتا و تست تحمل گلوکز در زنان باردار با اضافه وزن و چاق
    بررسی اثر مشاوره مبتنی بر رفتارهای ارتقا دهنده سلامت در کنترل قند خون ناشتا و تست تحمل گلوکز
    The impact of group motivation interview on health promotion behaviors psychological well-being and gestational diabetes mellitus in over weight pregnant women
    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
    تاثیر مصاحبه انگیرشی گروهی مبتنی بر رفتارهای ارتقا دهنده سلامت بر میانگین قند خون ناشتا و تست تحمل گلوکز در زنان باردار با اضافه وزن و چاق
    مقایسه اثربخشی مشاوره مبتنی بر رفتارهای ارتقا دهنده سلامت بر میانگین قند خون ناشتا و تست تحمل گلوکز در زنان باردار با اضافه وزن و چاق
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  • Intervention groups

    #1
    Behavior
    Lifestyle
    Intervention group: The Impact of group motivational interview
    Intervention group: The Impact of counseling based on health promoting behaviors
    گروه مداخله: اثر مصاحبه انگیزشی
    گروه مداخله: مشاوره مبتنی بر رفتارهای ارتقا دهنده سلامت

Protocol summary

Study aim
reduce the incidence of gestational diabetes
Design
Based on random numbers, the final sample size was 132 people (66 in the control group and 66 in the intervention group)
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
counseling based on health promoting behaviors standard pregnancy care
Main outcome variables
mean scores of fasting glucose and glucose tolerance test, mean scores of health promotion behaviors, psychological well-being.

General information

Reason for update
Acronym
IRCT registration information
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
Registration date
2018-07-05, 1397/04/14
Registrant information
Name
Narges Motahari
Name of organization / entity
Mazandaran University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7345
Email address
n.motahari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
2018-07-23, 1397/05/01
Actual recruitment end date
2019-02-09, 1397/11/20
Trial completion date
2019-04-09, 1398/01/20
Scientific title
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
Public title
The effect of counseling based on health-promoting behaviors on fasting blood glucose control and glucose tolerance test
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
pregnant women with gestational age 12 -16 weeks and body mass index >=25
Exclusion criteria:
Age
From 16 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Actual sample size reached: 148
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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
Health Research Center of Babol University of Medical Sciences
Street address
Babol, Ganj Afrouz Avenue, Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.068

Health conditions studied

1

Description of health condition studied
Diabetes mellitus in pregnancy
ICD-10 code
024
ICD-10 code description
Diabetes mellitus in pregnancy

Primary outcomes

1

Description
mean of fasting blood glucose-glucose tolerance test
Timepoint
First between 12 to 16 weeks of pregnancy and then between 26 to 28 weeks of gestational
Method of measurement
Laboratory measurement

Secondary outcomes

1

Description
Comparison of the mean of heath promotion behaviors in overweight and obese pregnant women
Timepoint
The first between 12 to 16 and then between 26 to 28 gestational
Method of measurement
Questionnaire

2

Description
Mean scores of psychological well-being in over weight and obese pregnant women
Timepoint
At first between 12 to 16 weeks and then between 26 to 28 gestational
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: The Impact of counseling based on health promoting behaviors
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Roohani Hospital
Full name of responsible person
Narges Sadat Motahari Tabari
Street address
Babol Roohani Hospital Ave, Gangafroose
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
narges_mth@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Narges Sadat Motahari Tabari
Street address
Babol Roohani Hospital Ave, Gangafroose
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
narges_mth@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Narges Sadat Motahari Tabari
Position
Midwifery Instractor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Baol Roohani Hospital Ave, Gangafroose
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
narges_mth@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Narges Sadat Motahari Tabari
Position
Midwifery Instractor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Babol Roohani Hospital Ave, Gangafroose
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
naeges_mth@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Narges Sadat Motahari Tabari
Position
Midwifery Instractor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Roohani Hospital Ave, Gangafroose
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
narges_mth@yahoo.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
No - There is not a plan to make this available
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