Clinical trial NCT02736214: Reproductive Life Plan-based Counseling With Men
Official title: Reproductive Life Plan-based Counseling With Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Lifestyle
Fertility
Pregnancy
Gender Role
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 229
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Visitors at drop-in hours at two clinics testing for sexually transmitted infections

Exclusion Criteria:

* Non-Swedish speaking
* Female gender identity

Primary outcomes:
measure: Knowledge of reproduction, measured by a total knowledge score
timeFrame: 2-3 months after the intervention
measure: Knowledge of lifestyle related factors that can affect fertility, measured by the total number of factors mentioned
timeFrame: 2-3 months after the intervention
Secondary outcomes:
measure: Overall experiences of the intervention (Likert-scale)
timeFrame: 2-3 months after the intervention
measure: Experience of discussing reproductive life plan (RLP) with a midwife (Likert-scale)
timeFrame: 2-3 months after the intervention
measure: Generating new thoughts (Likert-scale)
timeFrame: 2-3 months after the intervention
measure: Generating further knowledge seeking (Likert-scale)
timeFrame: 2-3 months after the intervention
measure: Implications for future health care seeking (Likert-scale)
timeFrame: 2-3 months after the intervention
measure: Implications for implementing RLP-counseling as a routine (yes/no)
timeFrame: 2-3 months after the intervention
measure: Likelihood of future lifestyle change (Likert-scale)
timeFrame: 2-3 months after the intervention
measure: Importance of discussing fertility and preconception health with men (Likert-scale)
timeFrame: 2-3 months after the intervention
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: The RFSU clinic
city: Uppsala
country: Sweden
facility: Flogsta Mansmottagning
Study officials:
affiliation: Uppsala University, Sweden
name: Maja Bodin
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University, Sweden
name: Margareta Larsson, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Stern 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.
citation: Frey 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.