Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention
NCT ID: NCT01997151
Last Updated: 2013-11-27
Study Results
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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COMPLETED
NA
374 participants
INTERVENTIONAL
2011-12-31
2013-08-31
Brief Summary
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Detailed Description
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Pregnant women, particularly those from under-served populations, often have a multitude of health behavior risks that threaten positive pregnancy and birth outcomes, as well as the future health of mother and baby. Pregnancy offers a window of opportunity for behavioral intervention. The immediate health risk for the baby motivates most pregnant women to at least consider changing their behavior. Furthermore, the regular and continual medical care that most pregnant women receive allows optimal access for intervention. The circumstance of pregnancy can be used as a teachable moment to better the future health of women and children.
The primary goals of this study were to complete and enhance the development of an iPad delivered intervention and to assess the efficacy in a randomized clinical trial involving pregnant women from three federally-funded community health centers that treat under-served populations. Using interactive technology, users complete onscreen assessments and receive individually tailored feedback messages on key behavior change strategies identified by the Transtheoretical Model of Behavior Change and matched to their stage of readiness for each behavior. Supplemental intervention components were created including printed feedback reports, a multiple behavior stage-based manual, and Spanish versions of all intervention materials. This intervention offers a cost-effective, science based, and easily deliverable solution to improve multiple health behaviors, and overall health and well-being, of populations of pregnant women.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Healthy Pregnancy: Step by Step
Pregnant women interacted with a multiple behavior change iPad- delivered program at federally funded health centers. The 20-30 minute program offered onscreen assessments of Transtheoretical Model strategies of change, and then provided individually tailored feedback messages matched to their readiness to change for relevant target behaviors. The program addressed smoking cessation and relapse prevention, stress management, and fruit and vegetable consumption. The feedback screens were interactive and engaging. The messages were written at a 4th-5th grade level and were reviewed for multicultural relevancy. Participants in the treatment group interacted with the program up to 3 times during pregnancy. A printed multiple behavior change guide also was distributed. All program components are available in English and Spanish.
Healthy Pregnancy: Step by Step
Usual Care
Pregnant women received regular prenatal care as delivered by the health care center from where they were receiving care. Standard informational March of Dimes brochures related to the target behaviors were distributed to usual care participants.
No interventions assigned to this group
Interventions
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Healthy Pregnancy: Step by Step
Eligibility Criteria
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Inclusion Criteria
* Speak and read either English or Spanish
* Consent to the research.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Pro-Change Behavior Systems
OTHER
Responsible Party
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Leanne Mauriello
Vice President of Research and Product Development
Principal Investigators
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Leanne D Mauriello, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Pro-Change Behavior Systems Inc.
References
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Mauriello L, Dyment S, Prochaska J, Gagliardi A, Weingrad-Smith J. Acceptability and feasibility of a multiple-behavior, computer-tailored intervention for underserved pregnant women. J Midwifery Womens Health. 2011 Jan-Feb;56(1):75-80. doi: 10.1111/j.1542-2011.2010.00007.x.
Prochaska JM, Mauriello L, Dyment S, Gokbayrak S. Designing a health behavior change program for dissemination to underserved pregnant women. Public Health Nurs. 2011 Nov-Dec;28(6):548-55. doi: 10.1111/j.1525-1446.2011.00959.x. Epub 2011 Aug 1.
Mauriello LM, Van Marter DF, Umanzor CD, Castle PH, de Aguiar EL. Using mHealth to Deliver Behavior Change Interventions Within Prenatal Care at Community Health Centers. Am J Health Promot. 2016 Sep;30(7):554-62. doi: 10.4278/ajhp.140530-QUAN-248. Epub 2016 Jun 16.
Other Identifiers
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GRANT10236132
Identifier Type: -
Identifier Source: org_study_id