Abstract
INTRODUCTION: Alcohol and tobacco use are common among U.S. women, yet if used during pregnancy these substances present significant preventable risks to prenatal and perinatal health. Because use of alcohol and tobacco often continue into the first trimester and beyond, especially among women with unintended pregnancies, effective evidence-based approaches are needed to decrease these risk behaviors. This study was designed to test the efficacy of CHOICES Plus, a preconception intervention for reducing the risk of alcohol- and tobacco-exposed pregnancies (AEPs and TEPs). STUDY DESIGN: RCT with two intervention groups: CHOICES Plus (n=131) versus Brief Advice (n=130). Data collected April 2011 to October 2013. Data analysis finalized February 2016. SETTING/PARTICIPANTS: Settings were 12 primary care clinics in a large Texas public healthcare system. Participants were women who were non-sterile, non-pregnant, aged 18-44 years, drinking more than three drinks per day or more than seven drinks per week, sexually active, and not using effective contraception (N=261). Forty-five percent were smokers. INTERVENTION: Interventions were two CHOICES Plus sessions and a contraceptive visit or Brief Advice and referral to community resources. MAIN OUTCOME MEASURES: Primary outcomes were reduced risk of AEP and TEP through 9-month follow-up. RESULTS: In intention-to-treat analyses across 9 months, the CHOICES Plus group was more likely than the Brief Advice group to reduce risk of AEP with an incidence rate ratio of 0.620 (95% CI=0.511, 0.757) and absolute risk reduction of -0.233 (95% CI=-0.239, -0.226). CHOICES Plus group members at risk for both exposures were more likely to reduce TEP risk (incidence rate ratio, 0.597; 95% CI=0.424, 0.840 and absolute risk reduction, -0.233; 95% CI=-0.019, -0.521). CONCLUSIONS: CHOICES Plus significantly reduced AEP and TEP risk. Addressing these commonly co-occurring risk factors in a single preconception program proved both feasible and efficacious in a low-income primary care population. Intervening with women before they become pregnant could shift the focus in clinical practice from treatment of substance-exposed pregnancies to prevention of a costly public health concern. TRIAL REGISTRATION: This study is registered at clinicaltrials.gov NCT01032772.