Los Angeles, California 90095


Purpose:

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.


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


Study is Available At:


Original ID:

IRB#15-001313


NCT ID:

NCT02529527


Secondary ID:


Study Acronym:


Brief Title:

Web-based Preconception Health Education Tool


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Los Angeles


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

340


Enrollment Type:

Anticipated


Overall Contact Information

Primary Contact:Priya Batra, MD, MS
3107942268
priyabatra@mednet.ucla.edu
Backup Contact:Tina Nguyen, MD
3107947274

Study Dates

Start Date:September 2015
Completion Date:September 2018
Completion Type:Anticipated
Primary Completion Date:September 2016
Primary Completion Type:Anticipated
Verification Date:February 2016
Last Changed Date:February 29, 2016
First Received Date:May 19, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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 sur
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Patient-reported discussion of preconception health with a provider at the primary care visit (measured by post-intervention patient survey: yes/no item)

Study Interventions

Intervention Type:Behavioral
Name:MyFamilyPlan
Description:Web-based preconception health education tool (interactive self-assessment) - to be completed by patient
Arm Name:MyFamilyPlan

Study Arms

Study Arm Type:No Intervention
Arm Name:Control
Description:Standard preconception health education document provided for participant review 7-10 days prior to a scheduled primary care visit.
Study Arm Type:Experimental
Arm Name:MyFamilyPlan
Description:Web-based health education tool (interactive self-assessment) provided for participant completion 7-10 days prior to a scheduled primary care visit.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Los Angeles

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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