PregnancyPREKNOPNCT01849900
Preconception Reproductive Knowledge Promotion (PREKNOP)
A study testing Knowing your body and Healthy Lifestyle in people with Pregnancy, run by Calvin College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Knowing your body and Healthy Lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to 30 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- low-income women of childbearing age
Who cannot join
- Menopause
- Hysterectomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Calvin College Nursing Department Community sites
Grand Rapids, Michigan, 49546
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Knowing your body, Healthy Lifestyle
- Keywords
- Menstrual cycle, Ovulation time, pregnancy recognition, Community-based participatory research, Unintended pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowing your bodyOther
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 LifestyleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Lifestyle | Other | 60 women randomly assigned to the control group Receives: Behavioral: Healthy Lifestyle |
| Knowing your body | Other | 60 women randomly assigned to intervention group Receives: Other: Knowing your body; Behavioral: Healthy Lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3, 6, 12, 18 and 24 months
Secondary outcomes (1)
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.
Measured: Baseline, 3 months, 6 months, 12 months, 18months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startFeb 2013
- Primary completion30 Apr 2017 (estimated)
- Study completion30 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Calvin College
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Adejoke Ayoola, Calvin College
- Investigators
- Adejoke B Ayoola, RN, PhD, Principal investigator, Calvin College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849900
- Sponsor's protocol ID
- 70315
- Acronym
- PREKNOP
- Status last verified
- Apr 2017
- First submitted
- 1 May 2013
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17439376Nettleman 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.
PubMed 17434017Finer 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.
PubMed 22018121Dott 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.
PubMed 19252975Ayoola 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.
PubMed 24958447Ayoola 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.
PubMed 23879232
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of the Preconception Reproductive Knowledge Promotion Intervention
- ClinicalTrials.gov ID
- NCT01849900
- Acronym / sponsor ID
- PREKNOP / 70315
- Conditions
- Pregnancy
- Keywords
- Menstrual cycle, Ovulation time, pregnancy recognition, Community-based participatory research, Unintended pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Calvin CollegeUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Feb 2013
- Primary completion
- 30 Apr 2017 (estimated)
- Study completion
- 30 Jun 2017 (estimated)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Lifestyle | Other | Behavioral: Healthy Lifestyle60 women randomly assigned to the control group |
| Knowing your body | Other | Other: Knowing your body, Behavioral: Healthy Lifestyle60 women randomly assigned to intervention group |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- low-income women of childbearing age
Key exclusion criteria (2 listed)
- Menopause
- Hysterectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowing your bodyWomen 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. | Other | Knowing your body |
| Healthy LifestyleWomen 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. | Behavioural | Healthy Lifestyle, Knowing your body |
Primary outcome
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.
1 secondary outcome
Change from baseline number of unplanned pregnancies
Time frame: Baseline, 3 months, 6 months, 12 months, 18months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Background: PubMed 17439376Ayoola 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.
- Background: PubMed 17434017Nettleman 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.
- Background: PubMed 22018121Finer 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.
- Background: PubMed 19252975Dott 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.
- Background: PubMed 24958447Ayoola 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.
- Background: PubMed 23879232Ayoola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adejoke B Ayoola, RN, PhD principal investigator
Calvin College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowing your body and Healthy Lifestyle in people with Pregnancy, run by Calvin College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01849900, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017; AzTrials last refreshed its copy on 30 Oct 2026.