Preconception Reproductive Knowledge Promotion (PREKNOP) (PREKNOP)

April 8, 2017 updated by: Adejoke Ayoola, Calvin College

Efficacy Study of the Preconception Reproductive Knowledge Promotion Intervention

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Calvin College Nursing Department Community sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • low-income women of childbearing age

Exclusion Criteria:

  • Menopause
  • Hysterectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
OTHER: Knowing your body
60 women randomly assigned to intervention 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3, 6, 12, 18 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months, 12 months, 18months, 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 6 months, 12 months, 18 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Calvin College

Collaborators

Robert Wood Johnson Foundation

Investigators

  • Principal Investigator: Adejoke B Ayoola, RN, PhD, Calvin College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

April 30, 2017

Study Completion (ANTICIPATED)

June 30, 2017

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (ESTIMATE)

May 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 8, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 70315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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