Determining the impact of the lifestyle modification educational package on childbearing
Design
The study will be conducted on 260 women who are randomly placed in two intervention and control groups. Block randomization method will be used for randomization using internet tools.
Settings and conduct
Sampling will be done in health centers located in the west and east of Karaj. At first, the researcher calls the eligible people using the phone number listed in their file and after explaining about the objectives and method of conducting the research and the confidentiality of the obtained information, she invites the eligible people to complete the questionnaires online. Each eligible person is placed in a list with a row number, block randomization is used for random allocation (block randomization internet tool).
Participants/Inclusion and exclusion criteria
Women aged 18-45, not suffering from chronic mental or physical illnesses، willingness to participate, not participating in similar educational-counseling programs
Intervention groups
This research is a randomized clinical trial study on married women referring to the West and East Karaj Health Center, who have the characteristics of the research unit, will be conducted from 08/30/1401. In the intervention group, group meetings will be held in 5 groups of 26 people. In order to implement the lifestyle modification training package in the intervention group, 5 sessions of 30-45 minutes each week will be held by a midwife and a psychiatrist with experience in the field of lifestyle modification training and with the coordination of the patients in a group.
Main outcome variables
Increasing awareness and desire for childbearing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220704055367N4
Registration date:2022-12-09, 1401/09/18
Registration timing:registered_while_recruiting
Last update:2022-12-09, 1401/09/18
Update count:0
Registration date
2022-12-09, 1401/09/18
Registrant information
Name
Fatemeh Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86701
Email address
fatemeh.abdi87@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the lifestyle modification educational package on the attitude to childbearing
Public title
Designing an educational package for increasing childbearing
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being married
Interest in participation in the study
Being able to read and write
Exclusion criteria:
Suffering from chronic mental or psychical disorder
Participation in other similar programs
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is used in the present study. This will be done using a random block internet tool via http://www.sealedenvelope.com/simple-randomiser/v1/lists. Block size is determined 4 and allocation was done upon arranges of codes in the blocks. Randomization will concealed in sequentially numbered, sealed, opaque envelopes. After producing randomization sequence, 112 opaque envelopes will be provided and each randomization sequence is recorded on a card, then placed in the envelope in order. To keep concealment, envelopes are numbered too. The envelope is sealed and placed in a box in order. At the beginning of the registration of participants, according to the order of entry of eligible participants to study, one of the envelopes will be opened and the assigned group of the participant will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a blinded clinical trial. Therefore, blinding will be implemented in the evaluators who will analyze the study data. For this purpose, the questionnaires that will be completed by the researchers in all three groups, in the form of a contract between the researchers. Also, it will be specified with one of the English letters above it, which questionnaire was completed by the participants of which of the study groups; However, the evaluators of the data analysis will not be aware of the English letter of agreement between the researchers assigned to each group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Alborz University of Medical Sciences
Street address
Alborz University of Medical Sciences, Shahrake Edari, North Taleghani, Azimieh, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-11-12, 1401/08/21
Ethics committee reference number
IR.ABZUMS.REC.1401.218
Health conditions studied
1
Description of health condition studied
childbearing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The average score of the questionnaire of childbearing desire developed by Ganjovi
Timepoint
Before the intervention and 1 month after the end of the intervention
Method of measurement
Ganjovi's questionnaire of childbearing desire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In order to implement the lifestyle modification training package in the intervention group, 5 sessions of 30-45 minutes each week will be held by a midwife and a psychiatrist with experience in the field of lifestyle modification training and with the coordination of patients in a group. The content of the lifestyle modification package from the pre-pregnancy diet chapter from the pregnancy nutrition book: a complete guide to healthy eating translated by Akram and Karmi, the pre- and post-pregnancy care book translated by Fatemeh Sohba and the pre-pregnancy exercise chapter from The book Motherhood (before pregnancy) written by Flora Tajiki will be prepared. The content of the sessions will include the following: Session 1: introduction and familiarization, stating the general goals of the intervention, stating how to perform the interventions, stating the topics of the sessions. Session 2: Pyramid of food, vitamins and minerals. Session 3: Start proper nutrition. Session 4: Suitable sports. Session 5: Teaching health tips.
Category
Lifestyle
2
Description
Control group: Receive routine services of selected centers
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centres located in west and east of Karaj
Full name of responsible person
Fatemeh Abdi
Street address
Resalat crossroad
City
Karaj
Province
Alborz
Postal code
3154646695
Phone
+98 26 3254 6372
Email
emamali@abzums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Razieh Lotfi
Street address
Alborz Univeirsity of Medical Sciences (ABZUMS), Northern Taleghani boulevard,Taleghani square
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
info@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Taleghani Boulevard,Taleghani square ,Karaj,Iran
City
Karaj
Province
Alborz
Postal code
45453424242
Phone
+98 26 3419 7000
Fax
Email
fatemeh.abdi87@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of nursing, Eshteraki street, Baghestan BLVD, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3433 6007
Email
fatemeh.abdi87@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Fatemeh Abdi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of nursing, Eshteraki street, Baghestan BLVD, Karaj, Iran
City
Karaj
Province
Alborz
Postal code
3146883811
Phone
+98 26 3433 6007
Email
fatemeh.abdi87@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to the main outcome and general demographic information can be shared.
When the data will become available and for how long
The access period starts 3 months after the results are published
To whom data/document is available
Doctors, nurses, midwives, researchers working in universities and medical centers and hospitals, Policy-makers
Under which criteria data/document could be used
In order to use it for scientific purposes and by mentioning the source used and requesting the journal in which the article will be published.
From where data/document is obtainable
Communication through e-mail (if possible to share information from a legal and ethical point of view, such as sharing the primary outcome of the study) To receive information, contact the following email address: fatemeh.abdi87@yahoo.com In the case of sending letter with regard to the current study, the following postal address of the corresponding author is available: School of nursing, Eshteraki street, Takhti Park, Baghestan BLVD
What processes are involved for a request to access data/document
Finding the responsible author's email, stating the reason, complying with ethical and legal issues; In this case, a quick response will be given to the requester.