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Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

Primary Purpose

Life Stress, Smoking Cessation, Poor Nutrition

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Healthy Pregnancy: Step by Step
Sponsored by
Pro-Change Behavior Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Life Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years old
  • Speak and read either English or Spanish
  • Consent to the research.

Exclusion Criteria:

  • More than 18 weeks gestation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Healthy Pregnancy: Step by Step

    Usual Care

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery
    Health risks were defined as not meeting criteria for smoking (not smoking), fruit and vegetable consumption (eating at least 5 servings a day), and stress management (effectively managing stress).
    Change in number of minutes spent on stress management each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery
    Change in number of servings of fruits and vegetables consumed each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery

    Secondary Outcome Measures

    Proportion who progress to the action criteria for effectively managing stress (at baseline not meeting criteria)
    Assessed by readiness to effectively manage stress each day.
    Proportion who progress to the action criteria for eating enough fruits and vegetables (at baseline not meeting criteria)
    Assessed by readiness to eat at least 5 servings of fruits and vegetables each day.

    Full Information

    First Posted
    November 22, 2013
    Last Updated
    November 22, 2013
    Sponsor
    Pro-Change Behavior Systems
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01997151
    Brief Title
    Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention
    Official Title
    Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2011 (undefined)
    Primary Completion Date
    August 2013 (Actual)
    Study Completion Date
    August 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pro-Change Behavior Systems

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This program of research tested the effectiveness of an iPad delivered multiple behavior intervention grounded in the Transtheoretical Model of Behavior Change for pregnant women. It was hypothesized that the intervention would reduce the number of health behavior risks reported by pregnant women in the treatment group. The target behaviors of the intervention are smoking cessation and relapse prevention, stress management, and fruit and vegetable consumption.
    Detailed Description
    Promoting health behaviors during pregnancy has tremendous public health significance. Poor health behaviors are associated with pregnancy complications, birth outcomes, and the health of the child. They influence infant birthweight, premature birth, and infant mortality rates, all of which continue to be public health concerns, reflected in the goals of Healthy People 2020. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Life Stress, Smoking Cessation, Poor Nutrition

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    374 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Pregnancy: Step by Step
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Healthy Pregnancy: Step by Step
    Primary Outcome Measure Information:
    Title
    Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery
    Description
    Health risks were defined as not meeting criteria for smoking (not smoking), fruit and vegetable consumption (eating at least 5 servings a day), and stress management (effectively managing stress).
    Time Frame
    Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
    Title
    Change in number of minutes spent on stress management each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery
    Time Frame
    Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
    Title
    Change in number of servings of fruits and vegetables consumed each day from Baseline at third trimester, 1 month post delivery, and 4 months post delivery
    Time Frame
    Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
    Secondary Outcome Measure Information:
    Title
    Proportion who progress to the action criteria for effectively managing stress (at baseline not meeting criteria)
    Description
    Assessed by readiness to effectively manage stress each day.
    Time Frame
    Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery
    Title
    Proportion who progress to the action criteria for eating enough fruits and vegetables (at baseline not meeting criteria)
    Description
    Assessed by readiness to eat at least 5 servings of fruits and vegetables each day.
    Time Frame
    Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years old Speak and read either English or Spanish Consent to the research. Exclusion Criteria: More than 18 weeks gestation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leanne D Mauriello, Ph.D.
    Organizational Affiliation
    Pro-Change Behavior Systems Inc.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21323854
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22092465
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26305603
    Citation
    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.
    Results Reference
    derived

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    Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

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