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PregnancyNCT03893084

Women's Health Behaviors Stages of Change (Transtheoretical Model) in Preconception Period

A study testing Pregnancy preparation training in people with Pregnancy and Women, run by Ege University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy, Women, Education
What is being tested?
Pregnancy preparation training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2018to 16 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • 17 Number Family Health Center

    Konya, 42250

Other trials in Turkey (Türkiye)

About this study

Official title: Women's Health Behaviors Stages of Change (Transtheoretical Model) in Preconception Period: A Randomized Control Study

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.

Read the detailed description

In order to reach for the second follow-up of women both her and her partner/mother phone number were registered.

Being tested
Pregnancy preparation training
Keywords
preconception, period, education, midwfiery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pregnancy preparation trainingOther

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

Study groups in NCT03893084
Study groupRoleWhat they receive
InterventionExperimentalPreconception guidance prepared by reference to the guidelines published in the literature, women were given pre-pregnancy training.
Receives: Other: Pregnancy preparation training
ControlNo interventionThe women in the control group were not given training, and routine practice was performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: eight weeks

  2. 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.

    Measured: eight weeks

  3. 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.

    Measured: eight weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2019
  2. Study start1 Jun 2018
  3. Primary completion1 Jun 2019
  4. Study completion16 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03893084
Sponsor's protocol ID
0000-0002-7453-1205
Status last verified
Aug 2024
First submitted
7 Mar 2019
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19888064

  • 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.

    PubMed 22353979

  • 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.

    PubMed 16773452

  • 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.

    PubMed 24853604

  • 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.

    PubMed 14960900

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

    PubMed 3644262

  • 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.).

Questions about this trial

What is this clinical trial studying?

A study testing Pregnancy preparation training in people with Pregnancy and Women, run by Ege University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Women's behavior change phase (time frame: eight weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03893084, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.

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