Determine and compare the effects of both group counseling and telephone counseling on the life style of women with gestational diabetes
Design
This study is a randomized clinical trial with three groups of patients, each group consisting of 22 pregnant women with gestational diabetes, available in each group
Settings and conduct
Diabetes Clinic and Beqaei Pour Clinic Available in Samples
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 20 to 40 years old; Iranian citizenship; confirmation of gestational diabetes with the approval of a specialist Diabetes Center in accordance with the guidelines; satisfaction to participate in the research; education level up; gestational age 24-28 weeks; native and resident of Yazd; phone access; not attending diabetes education classes before entering the study; having no diabetes before pregnancy by having a normal blood glucose test at the beginning of pregnancy.
Exit criteria: existence of severe or debilitating physical or mental illnesses that can be present; disconnects the program from the person; dissatisfaction with the continuation of the study; use of psychotropic substances and substance abuse.
Intervention groups
The study population of this study is all young women aged 20-40 years old with gestational diabetes referred to the Yazd Diabetes Care Research Center. Pregnant mothers who are pregnant with gestational diabetes based on the criteria of the Ministry of Health (FBS over 100); if they are eligible for inclusion in the study, they are invited to participate in the study.
Main outcome variables
Lifestyle associated with diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171106037289N2
Registration date:2018-04-24, 1397/02/04
Registration timing:retrospective
Last update:2018-04-24, 1397/02/04
Update count:0
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Fatemeh Dehghan Manghabadi
Name of organization / entity
Shahid Sadoughi University of Medical Sciences Yazd
Country
Iran (Islamic Republic of)
Phone
+98 35 3838 0590
Email address
fdehghan3788@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-01-21, 1396/11/01
Trial completion date
empty
Scientific title
The effect of group counseling and telephone counseling on the life style of women with gestational diabetes
Public title
The effect of group counseling and telephone counseling on the life style of women with gestational diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20 to 40 years old
Iranian citizenship
Confirmation of gestational diabetes with the approval of a Diabetes Center specialist according to the instructions
Satisfaction to participate in research
Top Level Education
Gestational age 24-28 weeks
Native to Yazd
Phone access
Not attending diabetes education classes before entering the study
Having no diabetes before pregnancy by having a normal blood glucose test at the beginning of pregnancy
Exclusion criteria:
Existence of severe or debilitating physical or mental illnesses that can be present
Disconnects the program from the person
Dissatisfaction with the continuation of the study
Use of psychotropic substances and substance abuse
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
66
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly divided into three groups of 20 individuals using randomized sampling. In the selection of individuals, participants, referees and researchers did not interfere.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, the main researcher, especially in the trials that Rasa University scholars have started, include health care personnel (doctors, nurses, physiotherapists, etc.) who are responsible for patient care, data collection authorities and those who Evaluate the outcome and, to a lesser extent, the Data Safety and Monitoring Committee's safety and data monitoring committee, and those who prepare the draft article, did not interfere in the assignment of samples to the three groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Yazd, Bahonar Square, Central building of Shahid Sadoughi University of Medical Sciences, Yazd
City
yazd
Province
Yazd
Postal code
8949333865
Approval date
2017-06-22, 1396/04/01
Ethics committee reference number
IR.SSU.MEDICINE.REC.1396.56
Health conditions studied
1
Description of health condition studied
Gestational diabetes and lifestyle
ICD-10 code
E10-E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
life style
Timepoint
Before intervention, after intervention and one month after intervention
Method of measurement
Diabetes Life Style Questionnaire
Secondary outcomes
1
Description
Quality Score
Timepoint
Before intervention, after intervention and one month after intervention
Method of measurement
Quality of Life questionnaire
Intervention groups
1
Description
Intervention group one (group counseling): An intervention program is organized in a total of 8 sessions of 90 minutes, a weekly one-session, in which each group counseling session will consist of 6 to 8 participants.
Category
Lifestyle
2
Description
Intervention group two (telephone counseling): The intervention program is held in a total of 8 sessions, a weekly meeting is held in the form of telephone counseling each week for thirty to forty-five minutes.
Category
Lifestyle
3
Description
Control group: This group does not receive any intervention. In order to observe ethical standards, at the end of the study, the educational content provided for the intervention group is given to the control group in print
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
iabetes Center and Baghaee Pour Clinic
Full name of responsible person
Fatemeh Dehghan Manghabadi
Street address
Shahid Dashti Blvd., 46th Alley, 13th Alley
City
yazd
Province
Yazd
Postal code
8949333865
Phone
+98 35 3838 0590
Email
fdehghan3788@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amir Houshang Mehparvar
Street address
Yazd, Bahonar Square, Headquarters of Yazd University of Medical Sciences
City
yazd
Province
Yazd
Postal code
8949333865
Phone
+98 35 3724 0171
Email
fdehghan446@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Dehghan Manghabadi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Blvd. Dashti, 46th Alley, 13th Alley
City
yazd
Province
Yazd
Postal code
8949333865
Phone
+98 35 3838 0590
Email
fdehghan3788@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shahnaz Mujahid
Position
Professor and faculty member of the university
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Safaieh, Bouali Ave., Faculty of Midwifery
City
yazd
Province
Yazd
Postal code
8949333865
Phone
+98 35 2824 9704
Email
sh_mojahed@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Dehghan Manghabadi
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Blvd. Dashti, 46th Alley, 13th Alley
City
yazd
Province
Yazd
Postal code
8949333865
Phone
+98 35 3838 0590
Email
fdehghan3788@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD