The role of participation in the women's health trial: feasibility study in minority populations

Abstract

Background: This paper examines participation rates and the association between participation and study outcomes (% energy from fat) among participants in the Women's Health Trial: Feasibility Study in Minority Populations, a randomized clinical trial to determine if ethnically and socioeconomically diverse women could be recruited and make significant dietary changes.

Methods: Women (n = 2,208) were recruited from three clinical centers and randomized to either an intervention group or a control group. Multiple measures were collected at 6 months.

Results: Participation rates for follow-up data collection activities were high (average participation 79%). Hispanics and lower educational groups participated significantly less (59% for Hispanics vs 86% for blacks and whites; 78% for lowest educational group vs 84% for highest educational group). Intervention participation significantly predicted change in percentage energy from fat (P < 0.001), accounting for an additional 8% of variance after background variables were controlled for.

Conclusions: These data suggest that intervention participation is positively related to dietary change, but they cannot rule out the possibility that other factors may influence both of these factors.