(1)Objectives:This study conducted as effectiveness of health literacy counseling on life style of high risk pregnant women affected by gestational diabetes.(2) Design:This is a randomized clinical trial without blinding.(3)Setting and conduct:2 selected centers in Alborz province(Alborz and Kamali hospitals)(4)Participants:The sample size will be 84 pregnant women in 2 selected centers.inclusion criteria: Iranian women between 18-35 years old,affected by gestational diabetes that they diagnosed at the first time in pregnancy by FBS or OGTT test and they have tendency and conscious consent to inter the study and they do not affect by other physical or psychological disorder and exclusion criteria: Unwillingness to continue participation in the study and if they do not present at least 2 sessions of total counseling sessions and affection to other disorder than diabetes.(5) Intervention: lifestyle counselling (6) main outcome measures: The primary outcome measure is lifestyle and secondary is gestational diabetes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021427728N3
Registration date:2017-04-05, 1396/01/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-05, 1396/01/16
Registrant information
Name
Zohreh Mahmoodi
Name of organization / entity
Nursing&Midwifery faculty
Country
Iran (Islamic Republic of)
Phone
+98 26 3430 4433
Email address
zohrehmahmoodi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Alborz University of Medical Sciences
Expected recruitment start date
2017-05-01, 1396/02/11
Expected recruitment end date
2017-09-01, 1396/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of health literacy consultation on lifestyle in women with high risk pregnancy in selected centers of Alborz province in 1396
Public title
The effectiveness of health literacy consultation on lifestyle in women with high risk pregnancy in selected centers of Alborz province in 1396
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Iranian women between 18-35 years old; affected by gestational diabetes that they diagnosed at the first time in pregnancy by FBS or OGTT test; have tendency and conscious consent to inter the study; do not affect by other physical or psychological disorder.
Exclusion criteria: Unwillingness to continue participation in the study; if they do not present at least 2 sessions of total counseling sessions; affection to other disorder than diabetes.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block sampling with random numeral
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz University of Medical Sciences
Street address
ninth floor, Dara building, north Yasmin, east Pune street, 45 Yards of Golshahr, karaj, Iran
City
karaj
Postal code
Approval date
2017-01-28, 1395/11/09
Ethics committee reference number
Abzums.Rec.1395.146
Health conditions studied
1
Description of health condition studied
Gestational diabetes mellitus
ICD-10 code
O24.9
ICD-10 code description
Diabetes mellitus in pregnancy, unspecified
Primary outcomes
1
Description
life style
Timepoint
Before intervention _ Immediately after the intervention -3 weeks after intervention
Method of measurement
use of questionaire
Secondary outcomes
1
Description
health literacy
Timepoint
Before intervention; Immediately after the interventio; 3 weeks after intervention
Method of measurement
use of questionaire
Intervention groups
1
Description
1-Intervention group : In this group hold 6 health literacy consultation sessions weekly .The time of each session is 90 minute.
In the control group: hold 6 routine consultation sessions weekly and The time of each session is 90 minute
Category
Lifestyle
2
Description
2-control group :They receive routine consultation