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Clinical Trials/NCT02529527
NCT02529527CompletedNot Applicable

MyFamilyPlan: A Patient-Centered Web-based Preconception Health Education Tool

University of California, Los Angeles1 site in 1 country292 target enrollmentStarted: September 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
292
Locations
1
Primary Endpoint
Proportion of women (intervention vs. control) reporting discussion of preconception health with provider at the primary care visit

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

MyFamilyPlan

Experimental

Web-based health education tool (interactive self-assessment) provided for participant completion 7-10 days prior to a scheduled primary care visit.

Intervention: MyFamilyPlan (Behavioral)

Control

No Intervention

Standard preconception health education document provided for participant review 7-10 days prior to a scheduled primary care visit.

Outcomes

Primary Outcomes

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 Outcomes

  • Numerical change in reported patient self-efficacy with respect to pregnancy planning before and after exposure to education tool (score range: 0-60)(7-10 days after exposure to intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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