Preconception Reproductive Knowledge Promotion (PREKNOP)

NCT01849900 | Unknown DMC

• 1 other identifier: 70315
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines the efficacy of the "Preconception Reproductive Knowledge Promotion (PREKNOP)" intervention, designed to promote women's reproductive health and positive pregnancy outcomes. The study's goal is to educate low-income women about reproductive changes related to their menstrual cycle. The main hypothesis of the study is that women who receive the PREKNOP intervention will report reduced risk of unplanned pregnancy and increased reproductive knowledge, self-efficacy about that knowledge, and pregnancy planning ability.

Conditions

Pregnancy

Keywords

Menstrual cycle; Ovulation time; pregnancy recognition; Community-based participatory research; Unintended pregnancy

Outcome Measures

Primary Outcomes (1)

• Change from baseline reproductive knowledge of ovulation, menstrual cycle, peak fertile times, and early signs of pregnancy.

  The investigators will measure if there is an increase in reproductive knowledge of ovulation time, menstrual cycle, peak fertile times, and early signs of pregnancy among the 120 participants in the study. The investigators will compare if there is higher increase in knowledge among the intervention group compared to the 60 participants in control group.

  Baseline, 3, 6, 12, 18 and 24 months

Secondary Outcomes (1)

• Change from baseline number of unplanned pregnancies

  Baseline, 3 months, 6 months, 12 months, 18months, 24 months

Other Outcomes (1)

• Change in self-efficacy about reproductive knowledge and pregnancy planning ability

  Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

Study Arms (2)

Healthy Lifestyle

OTHER

60 women randomly assigned to the control group

Behavioral: Healthy Lifestyle

Knowing your body

OTHER

60 women randomly assigned to intervention group

Other: Knowing your body; Behavioral: Healthy Lifestyle

Interventions

Knowing your body OTHER

Women will receive the "Knowing your body" kit. The kit contains: 6 ovulation test strips, a 12 month menstrual log sheet/calendar, and a thermometer to help women determine their body temperature; and educational materials that contain information on female body parts involved in pregnancy, hormones and the menstrual cycle, how birth control works, body temperature changes, characteristics of cervical fluid, and adapting to pregnancy during the first trimester. Participants will receive a total of 10 visits. During the first visit, the nursing student/community health workers team will review the intervention kit and continue to discuss topics related to women's health during subsequent visits.

Knowing your body

Healthy Lifestyle BEHAVIORAL

Women will receive educational materials on healthy lifestyle such as maintaining good nutrition and the importance of folic acid for women of childbearing age during the first visit. Participants will receive a total of 10 visits. The nursing student/community health workers team will continue to discuss topics related to promoting healthy lifestyle during subsequent visits.

Healthy Lifestyle; Knowing your body

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• low-income women of childbearing age

You may not qualify if:

• Menopause
• Hysterectomy

Sponsors & Collaborators

• Calvin College: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Calvin College Nursing Department Community sites

Grand Rapids, Michigan, 49546, United States

Location

Related Publications (6)

• Ayoola AB, Nettleman M, Brewer J. Reasons for unprotected intercourse in adult women. J Womens Health (Larchmt). 2007 Apr;16(3):302-10. doi: 10.1089/jwh.2007.0210.

  PMID: 17439376 BACKGROUND

• Nettleman MD, Chung H, Brewer J, Ayoola A, Reed PL. Reasons for unprotected intercourse: analysis of the PRAMS survey. Contraception. 2007 May;75(5):361-6. doi: 10.1016/j.contraception.2007.01.011. Epub 2007 Mar 12.

  PMID: 17434017 BACKGROUND

• Finer LB, Zolna MR. Unintended pregnancy in the United States: incidence and disparities, 2006. Contraception. 2011 Nov;84(5):478-85. doi: 10.1016/j.contraception.2011.07.013. Epub 2011 Aug 24.

  PMID: 22018121 BACKGROUND

• Dott M, Rasmussen SA, Hogue CJ, Reefhuis J; National Birth Defects Prevention Study. Association between pregnancy intention and reproductive-health related behaviors before and after pregnancy recognition, National Birth Defects Prevention Study, 1997-2002. Matern Child Health J. 2010 May;14(3):373-81. doi: 10.1007/s10995-009-0458-1. Epub 2009 Feb 28.

  PMID: 19252975 BACKGROUND

• Ayoola AB, Zandee GL, Johnson E, Pennings K. Contraceptive use among low-income women living in medically underserved neighborhoods. J Obstet Gynecol Neonatal Nurs. 2014 Jul-Aug;43(4):455-64. doi: 10.1111/1552-6909.12462. Epub 2014 Jun 24.

  PMID: 24958447 BACKGROUND

• Ayoola AB, Zandee GL. Low-income women's recommendations for promoting early pregnancy recognition. J Midwifery Womens Health. 2013 Jul-Aug;58(4):416-22. doi: 10.1111/jmwh.12078. Epub 2013 Jul 23.

  PMID: 23879232 BACKGROUND

Study Officials

• Adejoke B Ayoola, RN, PhD

  Calvin College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 9, 2013
• Study Start: February 1, 2013
• Primary Completion: April 30, 2017
• Study Completion: June 30, 2017
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

US (1)