Determinate the effect of group counseling based on Health Belief Model on nutritional behavior of Pregnant women with overweight
Design
This is a randomized clinical trial in which 90 eligible pregnant women were randomly assigned into two groups of intervention and control.
Settings and conduct
Overweight pregnant women who go to Kermanshah Comprehensive Health Centers during the study will enter the study if they are eligible.
Participants/Inclusion and exclusion criteria
All pregnant women overweight; Twin pregnancy; Gestational age 6 to 10 weeks; Reading and writing literacy; lack of underlying diseases and addiction; Pregnancy wanted
Withdrawal conditions: any medical or midwifery problems during the study; Failure to attend more than one consultation session; Occurrence of adverse events during the study
Intervention groups
Routine pregnancy care and group counseling base on health belief model 60-45 minutes per week for 4 weeks
Main outcome variables
Initial outcome: Investigate nutritional behavior before and 4 weeks after the intervention using a researcher-made questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200523047548N1
Registration date:2020-05-26, 1399/03/06
Registration timing:retrospective
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
sahar saadatnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3839 2625
Email address
saharsaadatnia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
2019-01-05, 1397/10/15
Actual recruitment end date
2020-01-05, 1398/10/15
Trial completion date
2020-01-05, 1398/10/15
Scientific title
The effect of group counseling based on Health Belief Model on nutritional behavior of Pregnant women with overweight:Randomized clinical trial
Public title
The effect of group counseling based on Health Belief Model on nutritional behavior of Pregnant women with overweight
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Single pregnancy
Gestational age 6 to 10 weeks
Body mass index 25 to 29/9
Reading and writing litercy
Lack of ohter disease
Wanted pregnancy
Exclusion criteria:
any medical or midwifery problems during the study
Failure to attend more than one consultation session
Occurrence of adverse events during the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the total global health centers of the eight centers were randomly selected using the draw-up of the sealed envelopes, among which 8 Center 4 center was randomly selected by the application of the sealed envelopes and the experimental group was considered 4 other centers of the control group. Using the available information in the comprehensive health centers system among individuals with inclusion criteria, samples were selected using random numbers. The method of allocation of subjects to experimental and control groups was simple randomly with sealed envelopes.
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Vice Chancellor for Research and Technology
City
hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2018-12-01, 1397/09/10
Ethics committee reference number
IR.UMSHA.REC.1397.617
Health conditions studied
1
Description of health condition studied
Nutritional behavior
ICD-10 code
Z71.3
ICD-10 code description
Dietary counseling and surveillance
Primary outcomes
1
Description
Investigating Nutritional Behavior
Timepoint
Before the intervention and 4 weeks later
Method of measurement
Using a researcher-made questionnaire Based on health belief model
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group: routine care of pregnancy and group counseling of 60-45 minutes per week for 4 weeks based on health belief model by presenting pamphlets and educational pamphlets
Category
Other
2
Description
Control group: There was no intervention and only prenatal care was performed. After the end of the study, the consultations provided to the case group, will also be placed in pamphlet and pamphlets at the discretion of the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health centers in Kermanshah
Full name of responsible person
Sahar Saadatnia
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Faculty of midwife nursing
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 83 3839 2625
Email
saharsaadatnia@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Science
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sahar Saadatnia
Position
دانشجوی کارشناسی ارشد مشاوره در مامایی
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences, Faculty of Nursing midwifery
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 83 3839 2625
Email
saharsaadatnia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Farzaneh Soltani
Position
Reproductive health specialist
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
خیابان شهید فهمیده,دانشگاه علوم پزشکی همدان,دانشکده پرستاری مامایی
City
Hamadan
Province
Hamadan
Postal code
651738695
Phone
+98 81 3838 0572
Email
farzanehsoltani2008@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sahar Saadatnia
Position
MSC Student in midwifery counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
ُShahid Fahmideh St, Hamadan University of Medical Sciences, Faculty of Nursing midwifery
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 83 3839 2625
Email
saharsaadatnia@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