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Web-based Preconception Health Education Tool

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02529527
Recruitment Status : Completed
First Posted : August 20, 2015
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
University of California, Los Angeles

Brief Summary:

Strong evidence supports that preconception care, or care to optimize a woman's health health prior to pregnancy, can improve birth outcomes. Preconception health counseling covers a broad range of topics, including: desire for pregnancy, obstetric history, nutrition, vaccinations, sexual health, chronic disease, substance abuse, mental health and contraception. Despite calls from public health organizations and experts in the field for universal access to preconception care, most US women do not receive any health counseling to prepare for pregnancy. Given that approximately half of US pregnancies are unintended, it is critical that routine primary care serve as a venue for the provision of this important service. From a patient's perspective, improving preconception health involves many health behavior changes. As such, patient engagement and education regarding preconception health must be a primary focus. Several preconception health promotion tools have been developed for patients to date; few are truly patient-centered and even fewer have been rigorously evaluated.

This study presents MyFamilyPlan - a novel, web-based, patient centered preconception health education tool designed for women of reproductive age receiving primary care. MyFamilyPlan is truly innovative in two key ways:

  • MyFamilyPlan is a web-based preconception health self-assessment. This will allow for the employment of skip logic to individualize the questionnaire and subsequent health recommendations for each patient.
  • Recognizing that preconception care is relevant to all women "at risk" of pregnancy, MyFamilyPlan has been designed for utilization in a primary care setting.

This preconception health education tool will be tested using a randomized controlled design. This study will measure whether or not exposure to MyFamilyPlan promotes the discussion of preconception health issues in primary care encounters (primary outcome). It will also evaluate whether the intervention affects participant self-efficacy in planning a healthy pregnancy, and relevant health behaviors (secondary outcome). The study proposed here will improve the quality of evidence for preconception health education tools. Should it demonstrate effectiveness, it will also result in a new tool that could be made more widely available to promote preconception health.


Condition or disease Intervention/treatment Phase
Reproductive Health Behavioral: MyFamilyPlan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Health Services Research
Official Title: MyFamilyPlan: A Patient-Centered Web-based Preconception Health Education Tool
Study Start Date : September 2015
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : June 1, 2016

Arm Intervention/treatment
Experimental: MyFamilyPlan
Web-based health education tool (interactive self-assessment) provided for participant completion 7-10 days prior to a scheduled primary care visit.
Behavioral: MyFamilyPlan
Web-based preconception health education tool (interactive self-assessment) - to be completed by patient

No Intervention: Control
Standard preconception health education document provided for participant review 7-10 days prior to a scheduled primary care visit.



Primary Outcome Measures :
  1. Proportion of women (intervention vs. control) reporting discussion of preconception health with provider at the primary care visit [ Time Frame: 7-10 days after exposure to intervention ]
    Patient-reported discussion of preconception health with a provider at the primary care visit (measured by post-intervention patient survey: yes/no item)


Secondary Outcome Measures :
  1. Numerical change in reported patient self-efficacy with respect to pregnancy planning before and after exposure to education tool (score range: 0-60) [ Time Frame: 7-10 days after exposure to intervention ]
    Change in self-efficacy score (patient-rated) after exposure to intervention or control (measured by change in 6-item validated Reproductive Health and Behaviors self-efficacy score between pre-intervention patient survey and post-intervention patient survey)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-45 years of age
  • English-speaking
  • Non-pregnant
  • Capable of pregnancy (i.e., no previous hysterectomy or sterilization procedure)
  • Scheduled primary care visit in health system in the upcoming 7-10 days
  • Active email address

Exclusion Criteria;

  • Currently pregnant

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): NCT02529527


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02529527    
Other Study ID Numbers: IRB#15-001313
First Posted: August 20, 2015    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017