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Reproductive Life Plan-based Counseling With Men

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ClinicalTrials.gov Identifier: NCT02736214
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Maja Bodin, 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.

Condition or disease Intervention/treatment Phase
Sexual Behavior Lifestyle Fertility Pregnancy Gender Role Behavioral: Reproductive Life Plan (RLP) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The randomization was blind to the participants, but they were made aware of their allocation during the intervention
Primary Purpose: Prevention
Official Title: Reproductive Life Plan-based Counseling With Men
Study Start Date : October 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : April 25, 2016

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.



Primary Outcome Measures :
  1. Knowledge of reproduction, measured by a total knowledge score [ Time Frame: 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


  2. 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 ]

    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 :
  1. Overall experiences of the intervention (Likert-scale) [ Time Frame: 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)


  2. Experience of discussing reproductive life plan (RLP) with a midwife (Likert-scale) [ Time Frame: 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)


  3. Generating new thoughts (Likert-scale) [ Time Frame: 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)


  4. Generating further knowledge seeking (Likert-scale) [ Time Frame: 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)


  5. Implications for future health care seeking (Likert-scale) [ Time Frame: 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)


  6. Implications for implementing RLP-counseling as a routine (yes/no) [ Time Frame: 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)


  7. Likelihood of future lifestyle change (Likert-scale) [ Time Frame: 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)


  8. Importance of discussing fertility and preconception health with men (Likert-scale) [ Time Frame: 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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-Swedish speaking
  • Female gender identity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736214


Locations
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Sweden
The RFSU clinic
Stockholm, Sweden, 118 26
Flogsta Mansmottagning
Uppsala, Sweden, 75272
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: Maja Bodin Uppsala University, Sweden
Study Director: Margareta Larsson, PhD Uppsala University, Sweden