Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

Smoking Cessation Clinical Trial

Official title:

Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997151
• Other study ID #: GRANT10236132
• Secondary ID: 5R44DP001115-03
• Status: Completed
• Phase: N/A
• First received: November 22, 2013
• Last updated: November 22, 2013
• Start date: December 2011
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Pro-Change Behavior Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Life Stress
• Malnutrition
• Poor Nutrition
• Smoking Cessation

Intervention

Behavioral:
• Healthy Pregnancy: Step by Step

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pro-Change Behavior Systems

References & Publications (2)

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. — View Citation

Prochaska JM, Mauriello L, Dyment S, Gökbayrak 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Third trimester of pregnancy, 1 month post delivery, 4 months post delivery	No
Primary	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	No
Primary	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	No
Secondary	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.	Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery	No
Secondary	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.	Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery	No