Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

Not Applicable

Completed

• Conditions: Life Stress; Smoking Cessation; Poor Nutrition

• Registration Number: NCT01997151
• Lead Sponsor: Pro-Change Behavior Systems

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.

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-11
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-22
• Last Update Submitted: 2013-11-22
• Study First Posted: 2013-11-27
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 374

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery	Third trimester of pregnancy, 1 month post delivery, 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	Third trimester of pregnancy, 1 month post delivery, 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	Third trimester of pregnancy, 1 month post delivery, 4 months post delivery

Secondary Outcome Measures

Name	Time	Method
Proportion who progress to the action criteria for effectively managing stress (at baseline not meeting criteria)	Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery	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)	Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery	Assessed by readiness to eat at least 5 servings of fruits and vegetables each day.