A randomized controlled trial (RCT) was conducted to assess the effectiveness of the home visiting program "Pro Kind". A total of 755 primiparae with multiple risk factors were recruited through the end of 2009 in three German federal states (Lower Saxony, Bremen, Saxony) and were randomized into one of two research groups. All participants had access to standard community service; women in the treatment group also received a program of home visitation over a period of 2.5 years. Primary objectives were improvement of maternal health behavior during pregnancy and birth of a healthy child. Long-term objectives are better outcomes of child health and development. To date, significant group differences in the primary objective variables are not detectable. Interim analyses at the ages of 6 and 12 months showed a tendency for a positive treatment effect on cognitive development. Methodological and practical limitations are critically discussed.