Reproductive Life Plan-based Counseling With Men
1 other identifier
interventional
229
1 country
2
Brief Summary
Many women and men in fertile age are at risk for sexual transmitted infections and unwanted pregnancies, and have insufficient knowledge of health promoting lifestyle prior to conception. There is a need to increase awareness among people in fertile age about how sexual risk-taking and unhealthy lifestyle can negatively affect fertility and pregnancy outcomes. Previous studies on preconception health and care have mainly focused on women. The aim of our study was to investigate if Reproductive Life Plan-based counseling with a midwife could increase men's reproductive knowledge. The second aim was to evaluate men's experiences of the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2016
CompletedMay 5, 2017
May 1, 2017
1.4 years
April 1, 2016
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Knowledge of reproduction, measured by a total knowledge score
Knowledge of reproduction will be measured by knowledge of the following items: * the viability of an ovum * the viability of sperm * how likely it is that a 25-year old women gets pregnant if she has unprotected intercourse at the time of ovulation * at what age there is a marked decline in women's ability to become pregnant * the proportion of infertility-cases that are caused by a male factor * success rate of IVF-treatment The outcome will be given as a total score, based on number of correct answers to the items above, and compared to the total score at baseline
2-3 months after the intervention
Knowledge of lifestyle related factors that can affect fertility, measured by the total number of factors mentioned
The participants will be asked to mention as many factors as they can remember that * can impair male fertility * could be modified in the preconception period to increase the chances of conception and having a healthy offspring The number of factors mentioned after the intervention will be compared to the number of factors mentioned at baseline
2-3 months after the intervention
Secondary Outcomes (8)
Overall experiences of the intervention (Likert-scale)
2-3 months after the intervention
Experience of discussing reproductive life plan (RLP) with a midwife (Likert-scale)
2-3 months after the intervention
Generating new thoughts (Likert-scale)
2-3 months after the intervention
Generating further knowledge seeking (Likert-scale)
2-3 months after the intervention
Implications for future health care seeking (Likert-scale)
2-3 months after the intervention
- +3 more secondary outcomes
Study Arms (2)
Lifestyle counseling
EXPERIMENTALThe intervention group answered a baseline questionnaire in the waiting room and received the intervention (Reproductive Life Plan) in addition to standard care.
Control group
NO INTERVENTIONThe control group answered a baseline questionnaire in the waiting room and received standard care.
Interventions
A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.
Eligibility Criteria
You may qualify if:
- Visitors at drop-in hours at two clinics testing for sexually transmitted infections
You may not qualify if:
- Non-Swedish speaking
- Female gender identity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The RFSU clinic
Stockholm, 118 26, Sweden
Flogsta Mansmottagning
Uppsala, 75272, Sweden
Related Publications (3)
Warner JN, Frey KA. The well-man visit: addressing a man's health to optimize pregnancy outcomes. J Am Board Fam Med. 2013 Mar-Apr;26(2):196-202. doi: 10.3122/jabfm.2013.02.120143.
PMID: 23471934BACKGROUNDStern J, Larsson M, Kristiansson P, Tyden T. Introducing reproductive life plan-based information in contraceptive counselling: an RCT. Hum Reprod. 2013 Sep;28(9):2450-61. doi: 10.1093/humrep/det279. Epub 2013 Jul 10.
PMID: 23842564BACKGROUNDFrey KA, Navarro SM, Kotelchuck M, Lu MC. The clinical content of preconception care: preconception care for men. Am J Obstet Gynecol. 2008 Dec;199(6 Suppl 2):S389-95. doi: 10.1016/j.ajog.2008.10.024.
PMID: 19081435BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maja Bodin
Uppsala University, Sweden
- STUDY DIRECTOR
Margareta Larsson, PhD
Uppsala University, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The randomization was blind to the participants, but they were made aware of their allocation during the intervention
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD-student
Study Record Dates
First Submitted
April 1, 2016
First Posted
April 13, 2016
Study Start
October 1, 2014
Primary Completion
March 1, 2016
Study Completion
April 25, 2016
Last Updated
May 5, 2017
Record last verified: 2017-05