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| Name | Class |
|---|---|
| Robert Wood Johnson Foundation | OTHER |
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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.
This study is a randomized, controlled trial of the PREKNOP intervention in a sample of 120 women 18-44 years old. Teams of nursing students and community health workers will administer the 12-month intervention. In addition to 10 home visits during which women will receive information on the female reproductive system and the expected monthly cyclical changes, PREKNOP will consist of use of ovulation test kits, a 12-month menstrual calendar, a digital thermometer, and educational brochures covering: the female reproductive anatomy, hormones and menstrual cycle, how to recognize ovulation period, various methods of birth control and how they work, and early pregnancy symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Lifestyle | Other | 60 women randomly assigned to the control group |
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| Knowing your body | Other | 60 women randomly assigned to intervention group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline number of unplanned pregnancies | The investigators will measure if there is a change in the number of unplanned pregnancies among the intervention group compared to the control group. | Baseline, 3 months, 6 months, 12 months, 18months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-efficacy about reproductive knowledge and pregnancy planning ability | The investigators will measure if there is an increase in self-efficacy score among the 120 participants in the study. The investigators will compare if there is higher increase among the 60 participants in the intervention group compared to the 60 participants in the control group. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adejoke B Ayoola, RN, PhD | Calvin College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calvin College Nursing Department Community sites | Grand Rapids | Michigan | 49546 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17439376 | Background | 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. | |
| 17434017 | 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. |
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| 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. |
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| 22018121 | 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. |
| 19252975 | 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. |
| 24958447 | 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. |
| 23879232 | 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. |