Reproductive Life Plan-based Counseling With Men

Study Overview
=================
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.

Official Title
-----------------
Reproductive Life Plan-based Counseling With Men

Conditions
-----------------
Sexual Behavior, Lifestyle, Fertility, Pregnancy, Gender Role

Intervention / Treatment
-----------------
* Behavioral: Reproductive Life Plan (RLP)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br>The intervention group answered a baseline questionnaire in the waiting room and received the intervention (Reproductive Life Plan) in addition to standard care. | Behavioral: Reproductive Life Plan (RLP)<br>* A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.<br>|
| No Intervention: Control group<br>The control group answered a baseline questionnaire in the waiting room and received standard care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall experiences of the intervention (Likert-scale) | 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) | 2-3 months after the intervention | 
| Experience of discussing reproductive life plan (RLP) with a midwife (Likert-scale) | 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) | 2-3 months after the intervention | 
| Generating new thoughts (Likert-scale) | 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) | 2-3 months after the intervention | 
| Generating further knowledge seeking (Likert-scale) | 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) | 2-3 months after the intervention | 
| Implications for future health care seeking (Likert-scale) | 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) | 2-3 months after the intervention | 
| Implications for implementing RLP-counseling as a routine (yes/no) | 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) | 2-3 months after the intervention | 
| Likelihood of future lifestyle change (Likert-scale) | 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) | 2-3 months after the intervention | 
| Importance of discussing fertility and preconception health with men (Likert-scale) | 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) | 2-3 months after the intervention |