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IRCT20220704055367N4 IRCT 2022-12-09 Karaj University of Medical Sciences Designing an educational package for increasing childbearing The effect of the lifestyle modification educational package on the attitude to childbearing 2022-12-06 anticipated 260 Complete https://irct.ir/trial/66949 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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 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. N/A childbearing. Intervention 1: 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. Intervention 2: Control group: Receive routine services of selected centers. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the main outcome and general demographic information can be shared. When: The access period starts 3 months after the results are published To whom: Doctors, nurses, midwives, researchers working in universities and medical centers and hospitals, Policy-makers Conditions: 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. Where to obtain: 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 How to obtain: 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. Comments:
public Fatemeh Abdi
Taleghani Boulevard,Taleghani square ,Karaj,Iran
Karaj Iran (Islamic Republic of) 45453424242 +98 26 3419 7000 fatemeh.abdi87@yahoo.com Karaj University of Medical Sciences scientific Fatemeh Abdi
School of nursing, Eshteraki street, Baghestan BLVD, Karaj, Iran
Karaj Iran (Islamic Republic of) 3146883811 +98 26 3433 6007 fatemeh.abdi87@yahoo.com Karaj University of Medical Sciences Iran (Islamic Republic of) Being married Interest in participation in the study Being able to read and write 18 years 45 years Female Suffering from chronic mental or psychical disorder Participation in other similar programs Lifestyle N/A 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. Control group: Receive routine services of selected centers 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. Karaj University of Medical Sciences Approved 2022-11-12 Research Ethics Committee of Alborz University of Medical Sciences Alborz University of Medical Sciences, Shahrake Edari, North Taleghani, Azimieh, Karaj Karaj Alborz Iran (Islamic Republic of)