Determining effect of counseling by motivational interview approach on lifestyle in preventing gestational obesity
Design
First, all pregnant women who meet the criteria for entering the study will be checked by the available sampling method, and if they are eligible, after explaining the goals and stages of the study and obtaining a written informed consent, the people included in the study and the study questionnaires by Contributors will be completed. A total of 188 people will be allocated to one of the two groups 1-control 2-intervention with a ratio of 1:1 using a random method with blocks of six, so that the researcher cannot predict which group the next person will be in. is placed.
Settings and conduct
The research environment will include midwifery clinics of Rouhani and Yahainejad hospitals in Babol city. intervention group, in addition to usual care, will be given health promotion lifestyle counseling with a motivational interview approach, and control group will only receive routine pregnancy care by gynecologists and midwives in clinics will be mentioned.
Participants/Inclusion and exclusion criteria
Inclusion criteria: a singleton pregnancy without complications, gestational age less than 14 weeks, having a normal body mass index (18.5-24.9), and having a smartphone. Exclusion criteria: history of eating disorders or bariatric surgery, serious medical and mental illness, history of mood disorders in the last three months, drug abuse and abortion
Intervention groups
In addition to routine care, the intervention group will receive health-promoting lifestyle counseling with a motivational interview approach, and the control group will only receive routine pregnancy care by gynecologists and midwives in the aforementioned clinics.
Main outcome variables
Gestational obesity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200122046228N6
Registration date:2024-04-21, 1403/02/02
Registration timing:prospective
Last update:2024-04-21, 1403/02/02
Update count:0
Registration date
2024-04-21, 1403/02/02
Registrant information
Name
Fatemeh Nasiri Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3230 2823
Email address
f.nasiri@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-29, 1403/02/10
Expected recruitment end date
2024-11-30, 1403/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with a motivational interview approach on health-promoting lifestyles in preventing of gestational obesity
Public title
The effect of counseling with a motivational interview approach on health-promoting lifestyles in preventing of gestational obesity
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
singleton pregnancy without complications
gestational age less than 14 weeks
having a normal body mass index (18.5-24.9)
having a smartphone
Exclusion criteria:
History of eating disorders
Medical diseases such as diabetes and high blood pressure,
History of mental disorders in the last three months
Drug abuse
Abortion
history of bariatric surgery
serious mental illness
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
In this parallel randomized controlled trial study, due to the fact that not all people are included in the study at the same time, and the researchers cannot predict in advance which group each patient will belong to. To assign each sample to one of the two groups, the block randomization method will be used. In order to hide the random allocation, the codes created by the software will be placed in opaque envelopes so that it is not clear which group the next person will be assigned to. Block random division (produced by Random Allocation Software) will be assigned to one of the two control and intervention groups with a ratio of 1:1 and in blocks of six, so that the researcher cannot predict which one the next person will be in. The intervention group is placed. The codes will be placed in the opaque envelopes, and with the entry of each new person, the envelope will be opened and the person's belonging to the relevant group will be determined.
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 Institute Babol University of Medcal Sciences
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
7176-47745
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.255
Health conditions studied
1
Description of health condition studied
excessive weight gain in pregnancy
ICD-10 code
O26.0
ICD-10 code description
Excessive weight gain in pregnancy
Primary outcomes
1
Description
Frequency of Excessive weight gain in pregnant women
Timepoint
Before the intervention at a gestational age of less than 14 weeks, after the end of the intervention at the 28th week of pregnancy and the 37th week of pregnancy
Method of measurement
Weight measurement using a seca height and weight scale made in Germany
Secondary outcomes
1
Description
Health promoting behaviors
Timepoint
At the beginning of the study and eight weeks after the end of the last intervention session and six weeks after delivery
Method of measurement
Health Promoting Lifestyle Profile (HPLP-2)
2
Description
General health
Timepoint
At the beginning of the study and eight weeks after the end of the last intervention session and six weeks after delivery
Method of measurement
General health questionnaire ( GHQ-28 )
3
Description
Pregnancy outcomes including type of delivery, weight at birth, age at birth and hospitalization of the neonate in the intensive care unit
Timepoint
24 hours after birth
Method of measurement
By calling and asking the mother
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to the usual pregnancy care, they will be given health-promoting lifestyle counseling with a motivational interview approach. The counseling training sessions of the health promoting lifestyle program will be conducted during six consecutive weeks from the 14th week on wards; The first, third and fifth sessions are face-to-face and the rest of the sessions each week are 15 minutes of online video counseling with WhatsApp, Eata, ... social networks, and 30 minutes of content will be audio and text. Having internet and a smartphone can open the file. To ensure that the content is read by the client, a follow-up call is made two days after the content is posted. In this way, the researcher will have the opportunity to provide individual counseling with each client. Face-to-face meetings will also be held individually for 50 minutes in one of the clinic rooms, observing all the necessary points for a reasonable consultation environment, including physical quality, no traffic of clients and no noise. It should be noted that before starting work, midwife counseling students learn the motivational interviewing approach under the supervision of a psychology consultant, and after gaining proficiency in the techniques of this approach and the approval of the relevant professors, Sampling begins under the supervision of professors. Also, during the implementation of the trial, telephone supervision will be done on a weekly basis.
Category
Prevention
2
Description
Control group: The control group will receive only usual prenatal care
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Azita Ghanbarpour
Street address
Babol, University Square, Ganj Afrooz St., Ayatollah Rouhani Hospital