Reproductive Life Plan-based Counseling With Men

NCT ID: NCT02736214

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-04-25

Brief Summary

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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

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Conditions

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Sexual Behavior Lifestyle Fertility Pregnancy Gender Role

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The randomization was blind to the participants, but they were made aware of their allocation during the intervention

Study Groups

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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.

Group Type EXPERIMENTAL

Reproductive Life Plan (RLP)

Intervention Type BEHAVIORAL

A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.

Control group

The control group answered a baseline questionnaire in the waiting room and received standard care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Reproductive Life Plan (RLP)

A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Non-Swedish speaking
* Female gender identity
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Maja Bodin

PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maja Bodin

Role: PRINCIPAL_INVESTIGATOR

Uppsala University, Sweden

Margareta Larsson, PhD

Role: STUDY_DIRECTOR

Uppsala University, Sweden

Locations

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The RFSU clinic

Stockholm, , Sweden

Site Status

Flogsta Mansmottagning

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 23471934 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23842564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19081435 (View on PubMed)

Related Links

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http://kbh.uu.se

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

Other Identifiers

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RLP-man-RCT

Identifier Type: -

Identifier Source: org_study_id

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