An interventional study of Knowing your body and Healthy Lifestyle in Pregnancy, sponsored by Calvin College. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-11.
Sponsored by Calvin College · Not applicable, Interventional, and Prevention
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.
This is the only study on the registry with Calvin College as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
60 women randomly assigned to the control group
Behavioral: Healthy Lifestyle
60 women randomly assigned to intervention group
Other: Knowing your body · Behavioral: Healthy Lifestyle
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.
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.
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.
Time frame: Baseline, 3, 6, 12, 18 and 24 months
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18months, 24 months
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.
Time frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months
This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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