NCT03893084

Brief Summary

H0: Preconceptional preparatory training period between pregnancies with and without women is no difference in terms of changes in health behavior. H1: Preconceptional preparatory training period between pregnancies with and without women there is a difference in terms of changes in health behavior.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

1 year

First QC Date

March 7, 2019

Last Update Submit

August 28, 2024

Conditions

Keywords

preconceptionperiodeducationmidwfiery

Outcome Measures

Primary Outcomes (3)

  • Women's behavior change phase

    The research was conducted by the researcher to evaluate the stages of behavior change related to the topics covered in preconceptional care. With the response to the questions, it is possible to determine which behavior change stage of the individuals. Women's behavioral changes were evaluated according to the five change stages on the transtheventional model. For the detailed evaluation of the individuals who are in the process of moving and maintaining, open-ended questions specific to each subject were asked.

    eight weeks

  • Healthy Lifestyle Behavior Scale-II

    Walker et al. (1987) developed a scale to evaluate health-promoting behaviors related to the individual's healthy lifestyle. Validity and reliability study was conducted by Bahar et al. (2008). The scale consists of 52 items and all items are positive. The rating is in the form of a four-point likert (1), sometimes (2), often (3), regularly (4). The lowest score is 52 and the highest score is 208. The total score of the scale determines the healthy lifestyle behavior score. The scale consists of six sub-dimensions: Health responsibility, Physical activity, Nutrition, Spiritual development, Interpersonal relations, Stress management.

    eight weeks

  • General Self-Efficacy Scale

    The scale was developed by Ralf Schwarzer and Mattihias Jerusalem (1995) in order to make a general assessment of perceived self-efficacy. The validity and reliability study of the scale was conducted by Aypay (2010). The scale applied to individuals aged 12 years or older consisted of 10 items. Self-sufficiency scale scores vary from 1 to 4 each. The lowest total score obtained from the scale is 10 and the highest score is 40. The high score from the self-efficacy scale indicates that the self-efficacy level is high.

    eight weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Preconception guidance prepared by reference to the guidelines published in the literature, women were given pre-pregnancy training.

Other: Pregnancy preparation training

Control

NO INTERVENTION

The women in the control group were not given training, and routine practice was performed.

Interventions

Pregnancy preparation education; folic acid use, physical activity, nutrition, addictions counseling issues are included.

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnancy education was given to women.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Accept to participate in the research and have signed the informed consent form,
  • Being over 18 years old,
  • To be literate,
  • Lack of a psychological diagnosis,
  • To be married,
  • Having no pregnancy,
  • Pregnancy is thought.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

17 Number Family Health Center

Konya, 42250, Turkey (Türkiye)

Location

Related Publications (7)

  • ACOG Committee Opinion No. 442: Preconception and prenatal carrier screening for genetic diseases in individuals of Eastern European Jewish descent. Obstet Gynecol. 2009 Oct;114(4):950. doi: 10.1097/AOG.0b013e3181bd12f4.

    PMID: 19888064BACKGROUND
  • Committee on Obstetric Practice. ACOG Committee Opinion No. 521: Update on immunization and pregnancy: tetanus, diphtheria, and pertussis vaccination. Obstet Gynecol. 2012 Mar;119(3):690-1. doi: 10.1097/AOG.0b013e31824e1327.

    PMID: 22353979BACKGROUND
  • Atrash HK, Johnson K, Adams M, Cordero JF, Howse J. Preconception care for improving perinatal outcomes: the time to act. Matern Child Health J. 2006 Sep;10(5 Suppl):S3-11. doi: 10.1007/s10995-006-0100-4. Epub 2006 Jun 14. No abstract available.

    PMID: 16773452BACKGROUND
  • Bhutta ZA, Das JK, Bahl R, Lawn JE, Salam RA, Paul VK, Sankar MJ, Blencowe H, Rizvi A, Chou VB, Walker N; Lancet Newborn Interventions Review Group; Lancet Every Newborn Study Group. Can available interventions end preventable deaths in mothers, newborn babies, and stillbirths, and at what cost? Lancet. 2014 Jul 26;384(9940):347-70. doi: 10.1016/S0140-6736(14)60792-3. Epub 2014 May 19.

    PMID: 24853604BACKGROUND
  • de Weerd S, Steegers EA. The past and present practices and continuing controversies of preconception care. Community Genet. 2002;5(1):50-60. doi: 10.1159/000064631.

    PMID: 14960900BACKGROUND
  • Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.

    PMID: 3644262BACKGROUND
  • Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. J. Weinman, S. Wright, & M. Johnston (Eds.), Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37.).

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The women who came to the institution were evaluated in terms of sample criteria and randomized sampling was divided into two groups. In order to be able to perform randomized sampling, random number table was obtained automatically by means of programs on internet sites by specifying the number of samples. The selection of the groups to the intervention and control group was determined by throwing a coin. In the data collection phase of the study, 218 women were evaluated in terms of sampling criteria. 10 women (who did not meet the criteria or refused to participate) were excluded from the study. 208 randomized women were divided into two groups as intervention and control group. During the follow-up, 15 women in the intervention group and 13 women in the control group were excluded from the study or were excluded because of pregnancy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2019

First Posted

March 28, 2019

Study Start

June 1, 2018

Primary Completion

June 1, 2019

Study Completion

July 16, 2019

Last Updated

August 30, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations