Reproductive Life Plan-based Counseling With Men

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Sexual Behavior; Fertility; Lifestyle; Gender Role
• Intervention / Treatment: Behavioral: Reproductive Life Plan (RLP)

• Study Type: Interventional
• Enrollment (Actual): 229
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 118 26
    • The RFSU clinic
  • Uppsala, Sweden, 75272
    • Flogsta Mansmottagning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Non-Swedish speaking
• Female gender identity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lifestyle counseling; 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); A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.
No Intervention: Control group; 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

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Maja Bodin, Uppsala University, Sweden; Study Director: Margareta Larsson, PhD, Uppsala University, Sweden

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Homepage of Department of Women's and Children's Health, Uppsala University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): April 25, 2016

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: RLP-man-RCT