Reproductive Life Plan-based Counseling With Men

Not Applicable

Completed

• Conditions: Lifestyle; Pregnancy; Fertility; Gender Role; Sexual Behavior
• Interventions: Behavioral: Reproductive Life Plan (RLP)

• Registration Number: NCT02736214
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Primary Completion: 2016-03
• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-13
• Study Completion: 2016-04-25
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-02
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 229

Inclusion Criteria

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

Exclusion Criteria

• Non-Swedish speaking
• Female gender identity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Reproductive Life Plan (RLP)	The intervention group answered a baseline questionnaire in the waiting room and received the intervention (Reproductive Life Plan) in addition to standard care.

Primary Outcome Measures

Name	Time	Method
Knowledge of reproduction, measured by a total knowledge score	2-3 months after the intervention	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
Knowledge of lifestyle related factors that can affect fertility, measured by the total number of factors mentioned	2-3 months after the intervention	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

Secondary Outcome Measures

Name	Time	Method
Overall experiences of the intervention (Likert-scale)	2-3 months after the intervention	Experience of the intervention is measured on a Likert-scale by the question of; - The participants overall experience of the intervention (very positive - very negative)
Generating new thoughts (Likert-scale)	2-3 months after the intervention	If the intervention could generate new thoughts on reproduction is measured on a Likert-scale by the question; - Has the intervention brought new thoughts about reproduction (In very large extent - in very small extent)
Generating further knowledge seeking (Likert-scale)	2-3 months after the intervention	If the intervention could lead to further knowledge seeking is measured on by the question; - Did the discussion with the midwife lead to a search for more information about reproduction (A lot more - some more - not at all)
Experience of discussing reproductive life plan (RLP) with a midwife (Likert-scale)	2-3 months after the intervention	Experience of discussing RLP with a midwife is measured on a Likert-scale by the question; - How was the experience of talking to a midwife about the reproductive life plan (very positive - very negative)
Implications for future health care seeking (Likert-scale)	2-3 months after the intervention	Whether the availability of discussing RLP with a midwife would be of future interest is measured on a Likert-scale by the question; - The likelihood of approaching a midwife if more questions about reproduction occured (Very likely - Very unlikely)
Implications for implementing RLP-counseling as a routine (yes/no)	2-3 months after the intervention	The acceptance of implementing RLP-counselling as a routine is measured by the question; - Should midwives or other health care professionals routinely discuss the Reproductive Life Plan with their patients (yes/no)
Likelihood of future lifestyle change (Likert-scale)	2-3 months after the intervention	Whether participants would consider making a preconception lifestyle change is measured on a Likert-scale by the question; - The likelihood among of making a lifestyle change in the future when planning for a pregnancy (Very likely - Very unlikely)
Importance of discussing fertility and preconception health with men (Likert-scale)	2-3 months after the intervention	The perceived significance of RLP-counselling is measured on a Likert-scale by the question; - The importance of informing/educating men about fertility and preconception health issues (Very important - Very unimportant)

Trial Locations

Locations (2)

The RFSU clinic; 🇸🇪 Stockholm, Sweden

Flogsta Mansmottagning; 🇸🇪 Uppsala, Sweden