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Promoting Health During Pregnancy: A Multiple Behavior Computer Tailored Intervention

Pro-Change Behavior Systems logo

Pro-Change Behavior Systems

Status

Completed

Conditions

Life Stress
Smoking Cessation
Poor Nutrition

Treatments

Behavioral: Healthy Pregnancy: Step by Step

Study type

Interventional

Funder types

Other

Identifiers

NCT01997151
GRANT10236132
5R44DP001115-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

374 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

374 participants in 2 patient groups

Healthy Pregnancy: Step by Step
Experimental group
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.
Treatment:
Behavioral: Healthy Pregnancy: Step by Step
Usual Care
No Intervention group
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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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