Problem/Objective: This 3 year quasi-experimental study evaluates the effectiveness of the Baby&Me Tobacco Free Program, a multi-pronged intervention that includes cessation counseling, biomarker feedback and an incentive program to facilitate prenatal and post-partum smoking cessation.

Methods: The intervention includes 4 face-to-face contacts prenatally with a cessation specialist who does counseling and carbon monoxide testing. The settings include 22 sites (WIC offices, obstetric and other clinics) in upstate New York. For 1 year post-partum, mothers are tested for carbon monoxide every 3 to 4 weeks and, if negative, receive a diaper voucher. To validate negative carbon monoxide tests, a random sample of women are tested for salivary cotinine. Primary outcomes include biochemically validated monthly abstinence rates ascertained by voucher receipt and a self reported quit rate at 12 months post-partum ascertained by telephone interview. To ensure implementation fidelity, program checklists are completed quarterly during site visits by supervisors. Monthly feedback on process indicators is provided. Three comparison groups have been selected to be as similar contextually as possible to the intervention sites while not being exposed to the intervention. Projecting a sample of 400 women in the intervention and 200 in the comparison groups, subgroup analyses will examine the differential effectiveness of the intervention by program intensity, implementation model and several potential confounding variables.

Results: 12 month follow-up results will be available for 41 study participants in October 2007.

Conclusions: This evaluation design causally attributes primary outcomes to program components, improves implementation through feedback, safeguards implementation fidelity and provides data to justify further investment.