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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03893084
• Other study ID #: 0000-0002-7453-1205
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 16, 2019

Study information

• Verified date: February 2020
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 16, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Education
• Pregnancy
• Women

Intervention

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

Locations

Country	Name	City	State
Turkey	17 Number Family Health Center	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

ACOG Committee on Genetics. 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):950-3. doi: 10.1097/AOG.0b013e3181bd12f4. — View Citation

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. Epub 2006 Jun 14. Review. — View Citation

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. Review. Erratum in: Lancet. 2014 Jul 26;384(9940):308. Sankar, Jeeva M [corrected to Sankar, M Jeeva]. — View Citation

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. — View Citation

de Weerd S, Steegers EA. The past and present practices and continuing controversies of preconception care. Community Genet. 2002;5(1):50-60. — View Citation

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.).

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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