This study will be done with aim to survey the effectiveness and non-effectiveness of cognitive-behavioral counseling on lifestyle and weight gain in pregnant women. This is a non-blinded clinical trial. The study population will included 20-24 weeks pregnant women who referred to health centers of Sanandaj city. A total of 70 eligible pregnant women will be selected in available method and randomly will be assigned in to two experimental and control groups. Baseline, health promoting lifestyle questionnaire will be provided to both groups, height and weight is measured and body mass index will be calculated. The intervention group will receive cognitive behavioral group counseling eight sessions (if necessary up to 10 sessions) of 60-90 minutes for a session in week. The control group only will receive the usual centers care. The end of the study and one month after the end of the study lifestyle questionnaire will be provided to both groups, the body mass index will be measured and both groups will be compared.
Inclusion criteria: Age between 19 and 50 years; 20-24 weeks gestational age; Literacy, Wanted pregnancy; Singleton pregnancy; No mental illness; No known fetal illness; No history of drug addiction;Lack of sleep medication use and Neurological drugs; Having a BMI underweight, normal, overweight and obese.
Exclusion criteria: Abortion; Childbirth or hospitalization during the study; No participation in the two or more sessions of meetings.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041014333N72
Registration date:2017-04-24, 1396/02/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-04-24, 1396/02/04
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
Expected recruitment start date
2017-04-30, 1396/02/10
Expected recruitment end date
2017-07-01, 1396/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness and non-effectiveness of cognitive-behavioral counseling on lifestyle and weight gain in pregnant women
Public title
The effectiveness and non-effectiveness of cognitive-behavioral counseling on lifestyle and weight gain in pregnant women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 19 years; 20-24 weeks gestational age; Literacy, Wanted pregnancy; No underlying disease or complications labeled in pregnancy (pre-eclampsia, gestational diabetes, a history of giving birth to infants and IUGR,…); Singleton pregnancy; No mental illness; No known fetal illness; No history of drug addiction;Lack of sleep medication use and Neurological drugs; Having a BMI underweight, normal, overweight and obese.
Exclusion criteria: Abortion; Childbirth or hospitalization during the study; No participation in the two or more sessions of meetings.
Age
From 19 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple randomly sampling, using encoded on the card
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Approval date
2017-03-08, 1395/12/18
Ethics committee reference number
kums.rec.1395.763
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
Z34.8
ICD-10 code description
Supervision of other normal pregnancy
Primary outcomes
1
Description
Life style
Timepoint
The beginning of the study, after study and one month after the end of the study
Method of measurement
Based on lifestyle questionnaire Walker (HPLP)
2
Description
Weight gain
Timepoint
The beginning of the study, after study and one month after the end of the study
Method of measurement
Weighbridge branded Seca
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive cognitive behavioral group counseling eight sessions (if necessary up to 10 sessions) of 60-90 minutes for a session in week.
Category
Lifestyle
2
Description
The control group only will receive the usual centers care.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers
Full name of responsible person
Mahnaz Farhoodi
Street address
Abidar Street
City
Sanandaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Koroush Hamzehee
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahnaz Farhoodi Moghadam
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
icdldoctor12@Gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Sosan Heydarpour
Position
PhD Reproductive Health
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of DolatabadBoulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
s.heydarpour1394@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahnaz Farhoodi Moghadam
Position
MA Student of consultation in midwifery
Other areas of specialty/work
Street address
School of Nursing & Midwifery, First of Dolatabad Boulvard,Eisar Square
City
Kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
icdldoctor12@Gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)