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The effect of an educational intervention based on the integration of the theory of planned behavior and the theory of social cognition on performing health behaviors before pregnancy of single-child couples: a clinical trial

Protocol summary

Study aim
Determining the effect of the educational intervention based on the integration of the theory of planned behavior and the theory of social cognition on performing health behaviors before pregnancy of single-child couples
Design
Clinical trial with control group, with parallel groups, randomized
Settings and conduct
This study will be conducted in Mashhad. Eligible people for the study will be extracted through the electronic system in health centers and will be randomly divided into two intervention and control groups, the intervention group will receive the designed training. The control group will also receive routine pre-pregnancy care in women.
Participants/Inclusion and exclusion criteria
inclusion criteria:Iranians and residents of Mashhad city, age 15-50 for men and 18-45 years for women with a single child at least 12 months old, having a health record in comprehensive health service centers, having at least elementary education. Declaration of consent to participate in Research. Criteria for exclusion from the study: withdrawal of one or both of the couples from continuing to cooperate in the research, secondary infertility, failure to participate in one or more of the training sessions, absolute and relative prohibition for pregnancy, incomplete completion of the questionnaire
Intervention groups
The intervention group will receive group training with lectures, group discussions and questions and answers. The control group will receive routine pre-pregnancy education
Main outcome variables
awareness, attitude, self-efficacy, behavioral intention, abstract norm, outcome expectation, facilitating conditions, Health behavior before pregnancy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220629055321N1
Registration date: 2022-09-14, 1401/06/23
Registration timing: registered_while_recruiting

Last update: 2022-09-14, 1401/06/23
Update count: 0
Registration date
2022-09-14, 1401/06/23
Registrant information
Name
Fatemeh Ghaffari sardasht
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
ghaffarif891@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-11, 1401/06/20
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an educational intervention based on the integration of the theory of planned behavior and the theory of social cognition on performing health behaviors before pregnancy of single-child couples: a clinical trial
Public title
The effect of educational intervention on performing health behaviors before pregnancy of single-child couples: a clinical trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranians and residents of Mashhad Age 15 to 50 years for men and women 18 to 45 years with only one child at least 12 months old Having health records in comprehensive health service centers Having at least primary education Declaration of consent to participate in the research
Exclusion criteria:
Secondary infertility Relative or absolute prohibition for pregnancy
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of fertile age couples to intervention and control groups will be done randomly with a random sequence generated using the randomization site, in such a way that for random assignment to the number of samples, we will get a code (code A and B) from the randomization site and We put these codes in a separate envelope in the same order as we got them from the site. Then we stack the envelopes in the order of the codes obtained from the aforementioned website. It should be noted that before starting the sampling, we will conduct a lottery to determine which of the A and B codes obtained from the randomization site will be considered as the intervention group and which code will be considered as the control group. During sampling, the first person who agrees to participate in the intervention takes the first envelope, and after opening the envelope, it is determined whether he is part of the control group or the intervention, and in the same way random allocation for all study samples. will be done. It should be noted that the person who creates the random sequence is different from the person who is involved in the registration process or allocation of participants.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants do not know in which group (intervention and control) they will be placed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
hafte-tir square
City
shahroud
Province
Semnan
Postal code
73943- 36147
Approval date
2019-05-08, 1398/02/18
Ethics committee reference number
IR.SHMU.REC.1398.025

Health conditions studied

1

Description of health condition studied
Performing the health behaviors before pregnancy
ICD-10 code
Z34
ICD-10 code description
Encounter for supervision of normal pregnancy

Primary outcomes

1

Description
Knowledge about health care before pregnancy, which is a set of health information to promote health before pregnancy.
Timepoint
Before, immediately and one month after the intervention
Method of measurement
A person's knowledge of pre-pregnancy health care is based on answering the questions in the knowledge section. which is given "one point" for correct answer to each question and "zero point" for each wrong answer or I don't know. The tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014

2

Description
Attitude towards pre-pregnancy health behaviors, which is the degree of desirability or undesirability of pre-pregnancy health behavior from a person's point of view.
Timepoint
Before, immediately and one month after the intervention
Method of measurement
The person's attitude is investigated with a questionnaire based on a 7-point Likert scale with a completely correct to completely incorrect spectrum, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014

3

Description
The abstract norm about pre-pregnancy health behaviors expresses the understanding of approval or rejection from family, friends or health workers to perform pre-pregnancy care.
Timepoint
Before, immediately and one month after the intervention
Method of measurement
The abstract norm in the individual is investigated with a questionnaire based on a 7-point Likert scale with a completely correct to completely incorrect spectrum, the tool usde psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014

4

Description
Perceived behavioral control regarding pre-pregnancy health behaviors refers to a person's understanding of the difficulty or ease of doing a task.
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Perceived behavioral control in a person is investigated with a questionnaire based on a 7-point Likert scale with a completely correct to completely incorrect range, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014

5

Description
Behavioral intention regarding pre-pregnancy health behaviors indicates the amount or extent of a person's motivation to perform health behaviors.
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Behavioral intention in a person is investigated with a questionnaire based on a 7-point Likert scale with a completely correct to completely incorrect range, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014

6

Description
Self-efficacy in performing prenatal health behaviors, which is one's perception or judgment of one's ability to perform a specific action successfully.
Timepoint
Before, immediately and one month after the intervention
Method of measurement
The self-efficacy in carrying out the health behavior of the person is investigated with a questionnaire according to a 7-point Likert scale with a completely correct to completely incorrect range, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014

7

Description
Expectancy of consequences regarding pre-pregnancy health behaviors, which represents the individual's opinion about the probability of various consequences of the behavior.
Timepoint
Before, immediately and one month after the intervention
Method of measurement
The expectation of the outcome in the individual is examined with a questionnaire based on a 7-point likert scale from completely agree to completely disagree.the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014

8

Description
Facilitating factors regarding the performance of pre-pregnancy health behaviors, which indicate a person's understanding of tools, resources or environmental changes that facilitate the formation of new behavior.
Timepoint
Before, immediately and one month after the intervention
Method of measurement
Facilitating factors in the individual are investigated with a questionnaire based on a 7-point Likert scale from completely agree to completely disagree, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014

Secondary outcomes

1

Description
Performing health behaviors before pregnancy
Timepoint
Before and one month after the intervention
Method of measurement
The health behavior questionnaire is divided into two parts. One section is about performing preconception health behaviors, which are answered as never, rarely, sometimes, often, and always. There are also some questions about pre-pregnancy care that can be answered with yes and no. The instrument used is a psychometric questionnaire to describe and predict health behavior before pregnancy based on the two theories of planned behavior and the theory of social cognition resulting from the doctorate thesis of Mrs. Ruqieh Bayrami in 2014

Intervention groups

1

Description
Intervention group: The intervention will be held in the form of 4 group training sessions (10 couples in each group) and in-person training using lecture, question and answer methods. The first session: the concept of health, physical and mental health, women's health, the importance of women's health, setting up a health plan, self-care, self-care areas, the second session: reproductive health, ovulation, menstrual cycle, reproductive life plan, age and fertility, reproductive period , the effect of age on fertility in men and women, pregnancy problems in old age (over 35 years) and young age (under 18 years old), the third session: having children, the effects and benefits of having children, the target group of having children, the appropriate age gap between children, the best time Having children, single children and its disadvantages, family planning and fertility control and the fourth session: Pre-pregnancy care, importance of pre-pregnancy care, importance of pre-pregnancy health, healthy lifestyle, pre-pregnancy health assessment, how to perform pre-pregnancy care In health centers, the method of physical and mental preparation for pregnancy (mental health, sexual health, oral and dental hygiene, nutrition and medicinal supplements, physical activities, smoking) was designed. The content of the educational intervention was designed based on the needs of couples (resulting from a qualitative study), experts' opinions, and the most up-to-date studies in the field of pre-pregnancy health.
Category
Other

2

Description
Control group: they will receive routine pre-pregnancy training from health centers. And the researcher will not interfere in their education.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
community health centre in Mashhad
Full name of responsible person
Zahra Motaghi
Street address
Hafte-tir Square, Shahroud University of Medical Sciences, Faculty of Medicine, Department of Reproductive Health
City
shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
zmotaghi8@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Hefte- Tir Square, Shahroud University of Medical Sciences and Health Care Services, Research and Technology Vice-Chancellor
City
shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
pishgiri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
zahra motaghi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Hafte-Tir Square, Shahrood University of Medical Sciences, Faculty of Medicine, Department of Reproductive Health
City
shahroud
Province
Semnan
Postal code
36147-73943
Phone
+98 23 3239 3962
Email
zmotaghi8@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
fatemeh ghaffari sardasht
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hafte-tir Square, Shahrood University of Medical Sciences, Faculty of Medicine, Department of Reproductive Health
City
shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 3962
Email
ghaffarif891@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
fatemeh ghaffari sardasht
Position
student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Hafte-Tir Square, Shahrood University of Medical Sciences, Faculty of Medicine, Department of Reproductive Health
City
shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 3962
Email
ghaffarif891@gmail.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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data can be published after the completion of the thesis
When the data will become available and for how long
One year after finishing the thesis
To whom data/document is available
Mashhad and Shahrood University of Medical Sciences - academic researchers
Under which criteria data/document could be used
After analysis, the data will be available to others through publication in scientific research journals.
From where data/document is obtainable
fatemeh ghaffari sardasht . Email: ghaffarif891@gmail.com
What processes are involved for a request to access data/document
Information will be available through printing the article. But if a person wants more information, he can express his request through email.
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