Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Poor Nutrition; Life Stress
• Intervention / Treatment: Behavioral: Healthy Pregnancy: Step by Step

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 Type: Interventional
• Enrollment (Actual): 374
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Healthy Pregnancy: Step by Step
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Pro-Change Behavior Systems
• Investigators: Principal Investigator: Leanne D Mauriello, Ph.D., Pro-Change Behavior Systems Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 27, 2013

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 22, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Nutrition Disorders; Stress, Psychological; Malnutrition
• Other Study ID Numbers: GRANT10236132; 5R44DP001115-03 (U.S. NIH Grant/Contract)