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OpenTrials
Completed

NCT Number: NCT01997151

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.

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Key information

Conditions

Life Stress Behavior Behavioral Symptoms Health Behavior Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Poor Nutrition Smoking Cessation Stress, Psychological

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Pregnancy: Step by Step

Behavioral

Primary outcomes

  1. Change in number of health behavior risks from Baseline at third trimester, 1 month post delivery, and 4 months post delivery

    Time frame: 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).

  2. 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

    Time frame: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery

  3. 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

    Time frame: Third trimester of pregnancy, 1 month post delivery, 4 months post delivery

Secondary outcomes

  1. Proportion who progress to the action criteria for effectively managing stress (at baseline not meeting criteria)

    Time frame: Third trimester of pregnancy, 1 month post delivery, and 4 months post delivery

    Assessed by readiness to effectively manage stress each day.

  2. Proportion who progress to the action criteria for eating enough fruits and vegetables (at baseline not meeting criteria)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pro-Change Behavior Systems

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2013
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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