This is the first report of findings from the CePAWHS randomized, controlled trial assessing the effectiveness of a behavior change intervention designed to improve the health of preconceptional and interconceptional women. The Strong Healthy Women intervention is a unique group format program targeting multiple health-related behaviors that are related to pregnancy outcomes. This initial randomized trial with pre- and interconceptional women recruited in low-income rural communities demonstrated a number of positive effects. The findings suggest that participation in the Strong Healthy Women intervention can significantly improve self-efficacy and behavioral intentions related to several risk factors for adverse pregnancy outcomes, as well as induce actual behavior change. Key attitudinal and behavior changes achieved were related to nutrition (including reading nutritional food labels and using folic acid supplementation, but not nutritional intake related to specific food groups) and physical activity levels. These are important findings; folic acid intake is associated with reduction in certain birth defects, and nutrition and physical activity are related to important areas of health risk, including overweight and obesity, diabetes, and cardiovascular health.
In addition, evidence was found for a dose–response effect in that the number of intervention sessions attended was linked with the strength of the intervention impact. Additional dose–response analyses were performed categorizing the number of sessions attended (data not shown). For several outcomes, intervention effects among those attending 3 sessions were significantly better than for those attending ≤2; also, the effects among those attending 3 sessions were not significantly different than for those attending ≥4 sessions. Hence, 3 sessions seems to be the optimum number of sessions. Feedback from the group facilitators and a sample of participants as part of a process evaluation provided some information about which modules were perceived as most interesting and effective, but there was no evidence that specific 2-hour sessions were less important than others. To assess this further, our future research will develop and test a 3-session version of the Strong Healthy Women intervention that covers the same topic areas but in a more compact format.
No significant differences in changes in anthropometric and biomarker measures were identified. We attribute these null findings to the relatively short interval of time between pre- and posttest (i.e., 14 weeks between baseline and follow-up risk assessments). Although it is possible to see changes in anthropometric and biomarker measures over this time period, such change would require relatively rapid and substantial change in behavior, rather than a gradual change, which is more realistic and attainable. In fact, the program content explicitly fostered gradual change by introducing potential behavior change in stages and providing support for the frequently tentative nature of initial change attempts. It is more likely that assessment after a longer follow-up period would allow detection of changes in these biomarkers. In future studies, we intend to conduct biomarker assessments over a 6-month follow-up period.
Other null findings are worth noting. The intervention had no significant effects on self-efficacy, behavioral intention, or behavior change in the areas of tobacco exposure (cigarette smoking and exposure to tobacco smoke in the home) and alcohol use. These are notoriously difficult behaviors to change, and it could be that the relatively brief attention to these topics within the context of the 6-session intervention was not sufficient to produce desired changes. In addition, we found no significant effects for use of stress management techniques, perhaps because the intervention could not address the underlying levels of stress experienced by participants. Finally, the intervention did not impact the prevention of gynecologic infections through reducing the use of vaginal douching or obtaining more preventive gynecologic health care; the latter might not be expected over a 14-week study period, because research shows that women seek preventive gynecologic health care approximately every 1−2 years (Salganicoff, Ranji, & Wyn, 2005
). Our longer-term survey follow-up may show an impact on use of preventive health care. With modifications in the intervention, some of these topic areas could be addressed more effectively in future research.
The results of this randomized trial are promising for specific outcomes variables. However, although the sample was diverse with respect to socioeconomic status and rural–urban residence, the sample was racially homogenous (predominantly non-Hispanic white) owing to the demographic characteristics of the underlying rural Central Pennsylvania population. A goal of future research is to test the Strong Healthy Women intervention, after it has been modified based on our experience in this trial, in a more racial/ethnically and geographically diverse population.
The public health and policy implications of this study are noteworthy. The promising results of this initial field trial suggest that the health-related behaviors and health risks of pre- and interconceptional women can be addressed outside of the clinical setting in community-based behavior change programs. This is an important insight because effective behavior change programs are likely to be too time consuming and labor intensive for most clinical settings in which women receive routine health services before becoming pregnant. Furthermore, because this field trial recruited women in high-risk and geographically dispersed low-income rural communities, the findings also provide evidence that the behavior change intervention approach can be successful in challenging populations. Although policy and financing discussions about preconception health tend to focus on expanding access to clinical services, the public policy agenda could be broadened to include increasing the availability and financing of community-based approaches to preconception health promotion, particularly in underserved communities.
It is also noteworthy that women in the intervention group seem to have gained increased control over their own health. For example, the ability to read food labels was enhanced. This skill, which may be taken for granted, should be promoted at the community and population levels to increase the response efficacy associated with policies behind labeling. The findings can inform potential interventions related to enhanced health literacy in the nutritional domain.
The need to develop evidence-based programs to improve preconception health has been highlighted by the CDC (2006)
. This test of the Strong Healthy Women
intervention provides initial evidence of the effectiveness of a unique program for reducing risks of adverse pregnancy outcomes among pre- and interconceptional women in high-risk communities. The results reported here provide the basis for further refinements to the Strong Healthy Women
intervention as well as a model for future preconception health interventions.