Overview

This trial is active, not recruiting.

Condition pregnancy
Treatments knowing your body, healthy lifestyle
Sponsor Calvin College
Collaborator Robert Wood Johnson Foundation
Start date February 2013
End date September 2016
Trial size 120 participants
Trial identifier NCT01849900, 70315

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Other)
60 women randomly assigned to the control group
healthy lifestyle
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.
(Other)
60 women randomly assigned to intervention group
knowing your body
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.
healthy lifestyle
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.

Primary Outcomes

Measure
Change from baseline reproductive knowledge of ovulation, menstrual cycle, peak fertile times, and early signs of pregnancy.
time frame: Baseline, 3, 6, 12, 18 and 24 months

Secondary Outcomes

Measure
Change from baseline number of unplanned pregnancies
time frame: Baseline, 3 months, 6 months, 12 months, 18months, 24 months

Eligibility Criteria

Female participants from 18 years up to 44 years old.

Inclusion Criteria: - low-income women of childbearing age Exclusion Criteria: - Menopause - Hysterectomy

Additional Information

Official title Efficacy Study of the Preconception Reproductive Knowledge Promotion Intervention
Principal investigator Adejoke B Ayoola, RN, PhD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Calvin College.