Web-based Preconception Health Education Tool

NCT ID: NCT02529527

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-06-01

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.

Conditions

Reproductive Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

MyFamilyPlan

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

Group Type: EXPERIMENTAL

MyFamilyPlan

Intervention Type: BEHAVIORAL

Web-based preconception health education tool (interactive self-assessment) - to be completed by patient

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MyFamilyPlan

Web-based preconception health education tool (interactive self-assessment) - to be completed by patient

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

References

Batra P, Mangione CM, Cheng E, Steers WN, Nguyen TA, Bell D, Kuo AA, Gregory KD. A Cluster Randomized Controlled Trial of the MyFamilyPlan Online Preconception Health Education Tool. Am J Health Promot. 2018 May;32(4):897-905. doi: 10.1177/0890117117700585. Epub 2017 Apr 10.

Reference Type: DERIVED

PMID: 28391703 (View on PubMed)

Other Identifiers

IRB#15-001313

Identifier Type: -

Identifier Source: org_study_id