ClinicalTrials.gov
ClinicalTrials.gov Menu

Preconception Reproductive Knowledge Promotion (PREKNOP) (PREKNOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01849900
Recruitment Status : Active, not recruiting
First Posted : May 9, 2013
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Adejoke Ayoola, Calvin College

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.

Condition or disease Intervention/treatment Phase
Pregnancy Other: Knowing your body Behavioral: Healthy Lifestyle Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy Study of the Preconception Reproductive Knowledge Promotion Intervention
Study Start Date : February 2013
Estimated Primary Completion Date : April 30, 2017
Estimated Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

Arm Intervention/treatment
Healthy Lifestyle
60 women randomly assigned to the control group
Behavioral: 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.

Knowing your body
60 women randomly assigned to intervention group
Other: 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.

Behavioral: 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 Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Change from baseline number of unplanned pregnancies [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18months, 24 months ]
    The investigators will measure if there is a change in the number of unplanned pregnancies among the intervention group compared to the control group.


Other Outcome Measures:
  1. Change in self-efficacy about reproductive knowledge and pregnancy planning ability [ Time Frame: Baseline, 3 months, 6 months, 12 months, 18 months, 24 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • low-income women of childbearing age

Exclusion Criteria:

  • Menopause
  • Hysterectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849900


Locations
United States, Michigan
Calvin College Nursing Department Community sites
Grand Rapids, Michigan, United States, 49546
Sponsors and Collaborators
Calvin College
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Adejoke B Ayoola, RN, PhD Calvin College

Additional Information:
Publications:
Responsible Party: Adejoke Ayoola, Dr., Calvin College
ClinicalTrials.gov Identifier: NCT01849900     History of Changes
Other Study ID Numbers: 70315
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Adejoke Ayoola, Calvin College:
Menstrual cycle
Ovulation time
pregnancy recognition
Community-based participatory research
Unintended pregnancy