To determine the effect of Prenatal Yoga on weight gain and maternal anxiety of pregnant women with excessive gestational weight gain that referred to Comprehensive health centers in Qom
Design
Sampling is Convenience but assigning individuals to the control and intervention groups is random
Settings and conduct
Participants will be accessed through Comprehensive health centers in Qom which are centers for pregnancy, new born and early parenting .After specifying the groups, we will have a weekly weight check. And our intervention, which was a yoga class, will be done in groups
Participants/Inclusion and exclusion criteria
Inclusion criteria :Primiparous women 18-46 years of age/ Diagnosed with (EGWG)/being at 24-30 weeks of gestation / healthy Singleton pregnancy/ Wiling to participate in the study / ability to attend at least one yoga per week for majority of intervention (i.e., at least 70% of sessions)/ do not already have a specific disease before pregnancy/No special complications in pregnancy/ have not participated in similar yoga or exercise courses
Exclusion:the patients will be excluding if they skip the yoga trainings for more than once during the intervention also in case of the occurrence of any conditions that turn the pregnancy into a high-risk condition.
Intervention groups
we have two groups :the control and intervention group .In addition to receiving routine care, the participants in the intervention group will contracted to perform Prenatal yoga group exercises for 6 weeks
Main outcome variables
Decrease Weight gain-Decrease anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110621006854N5
Registration date:2022-06-17, 1401/03/27
Registration timing:registered_while_recruiting
Last update:2022-06-17, 1401/03/27
Update count:0
Registration date
2022-06-17, 1401/03/27
Registrant information
Name
Elham Ebrahimi
Name of organization / entity
Azad University
Country
Iran (Islamic Republic of)
Phone
+98 22 1522 3903
Email address
ebrahimi_308@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Yoga on weight gain and maternal anxiety in women with excessive gestational weight gai
Public title
Yoga and maternal weight gain and anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous women 18-46 years of age
Diagnosed with (EGWG)
being at 24-30 weeks of gestation
healthy Singleton pregnancy
Wiling to participate in the study
ability to attend at least one yoga per week for majority of intervention
do not already have a specific disease before pregnancy and No special complications in pregnancy
have not participated in similar yoga or exercise courses
Exclusion criteria:
if they skip the yoga trainings for more than once during the intervention
in case of the occurrence of any conditions that turn the pregnancy into a high-risk condition.
Age
From 18 years old to 46 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Participants randomly using the site www.random.org and through Stratification quota random blocking with 4 and 6 block sizes and with ratio
1: 1 allocation to control and intervention groups (yoga receiving group and control group) (routine care)
Were allocated. Blocking was performed by a person not involved in sampling and data analysis. Direction
Hide allocation, type of intervention written on a piece of paper and inside opaque envelopes
Was numbered. These random envelopes after signing a written consent in
The presence of the mother was opened and the type of group was specified and the mother was informed.
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 the School of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Tehran School of Nursing and Midwifery, East Nosrat Street ,Tohid Square,Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-05-21, 1401/02/31
Ethics committee reference number
IR.TUMS.FNM.REC.1401.023
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
2
Description of health condition studied
Overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Overweight
Timepoint
6 weeks
Method of measurement
a research grade scale (Tanita WB-800S digital weight scale)
2
Description
Anxiety
Timepoint
6 weeks
Method of measurement
The State Trait Anxiety Inventory (STAI) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: yoga exercises twice a week for 6 weeks(includes yoga exercises with breathing exercises and relaxation). The names of each of these weeks are as follows:1) opening greeting/intention setting, 2) pranayama (i.e., breathing exercises), 3) warm-up/sun salutations (i.e., flowing sequence), 4) prenatal yoga sequence (e.g., combination of sun salutations, vinyasa (i.e., movement between poses), and standing, seated, and/or balancing poses), 5) cool-down 6) Savasana (i.e., final resting pose)
Category
Treatment - Other
2
Description
Control group: not doing yoga exercises(Routine pregnancy care with weekly weight check)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive health center of Qom province
Full name of responsible person
Dr. Bahareh Zare
Street address
Qom Health Center, facing Alley 6,20 meters from Beheshti Street, Imam Khomeini Street, Qom
City
Qom
Province
Ghoum
Postal code
3719714953
Phone
+98 25 3660 0017
Email
toghajalal@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tuqa Jalal Jumaah
Street address
first unit/tasnim apatment/Shahid taqi khosrobigi street/15khordad blv
City
Qom
Province
Ghoum
Postal code
3714861813
Phone
+98 25 3355 4721
Email
toghajalal@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
pPersonal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Elham Ebrahimi
Position
Professor and Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
The first door of a rural house,Haj Amini Alley,Farhang Street, Farameh Square, Damavand, Tehran
City
Qom
Province
Tehran
Postal code
۳۹۷۱۷۱۳۹۶۷
Phone
0253354721
Email
ebrahimi_308@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Elham Ebrahimi
Position
Professor and Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
The first door of a rural house,Haj Amini Alley,Farhang Street, Farameh Square, Damavand, Tehran
City
Tehran
Province
Tehran
Postal code
۳۹۷۱۷۱۳۹۶۷
Phone
+98 25 3355 4721
Email
ebrahimi_308@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tuqa Jalal Jumaah
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
first unit/tasnim apatment/Shahid taqi khosrobigi street/15khordad blv
City
Qom
Province
Ghoum
Postal code
3714861813
Phone
+98 25 3355 4721
Email
toghajalal@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participants information is protected and their names are not required.
When the data will become available and for how long
1401
To whom data/document is available
Reputable journals
Under which criteria data/document could be used
niversities of Medical Sciences
From where data/document is obtainable
Try not to use the documents personally
What processes are involved for a request to access data/document