Clinical trial NCT01997151: 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
Overall status: COMPLETED
Phase: NA
Conditions: Life Stress
Smoking Cessation
Poor Nutrition
Lead sponsor: Pro-Change Behavior Systems
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 374
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery
timeFrame: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
measure: 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
timeFrame: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
measure: 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
timeFrame: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery
Secondary outcomes:
measure: Proportion who progress to the action criteria for effectively managing stress (at baseline not meeting criteria)
timeFrame: Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery
measure: Proportion who progress to the action criteria for eating enough fruits and vegetables (at baseline not meeting criteria)
timeFrame: Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery
Other outcomes:
Locations:
Study officials:
affiliation: Pro-Change Behavior Systems Inc.
name: Leanne D Mauriello, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.