Overview

This trial is active, not recruiting.

Conditions sexual behavior, lifestyle, fertility, pregnancy, gender role
Treatment reproductive life plan (rlp)
Sponsor Uppsala University
Start date October 2014
End date March 2016
Trial size 200 participants
Trial identifier NCT02736214, RLP-man-RCT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
The intervention group answered a baseline questionnaire in the waiting room and received the intervention (Reproductive Life Plan) in addition to standard care.
reproductive life plan (rlp)
A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.
(No Intervention)
The control group answered a baseline questionnaire in the waiting room and received standard care.

Primary Outcomes

Measure
Knowledge of reproduction, measured by a total knowledge score
time frame: 2-3 months after the intervention
Knowledge of lifestyle related factors that can affect fertility, measured by the total number of factors mentioned
time frame: 2-3 months after the intervention

Secondary Outcomes

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

Eligibility Criteria

Male participants from 18 years up to 50 years old.

Inclusion Criteria: - Visitors at drop-in hours at two clinics testing for sexually transmitted infections Exclusion Criteria: - Non-Swedish speaking - Female gender identity

Additional Information

Official title Reproductive Life Plan-based Counseling With Men
Principal investigator Maja Bodin
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Uppsala University.