Comparison of characteristics and outcomes by initial study contact (website versus staff) for participants enrolled in a weight management study

Abstract

Background: Traditional recruitment methods for clinical trials, such as telephone, mail, and print media, are often inefficient, costly, and use large amounts of staff time and resources.

Purpose: This analysis was conducted to determine whether retention, demographics, and outcomes differed between enrolled participants who responded to recruitment outreach using an Internet-based information and registration system and enrollees whose first contact was with study staff via telephone.

Methods: We identified potentially eligible participants from Kaiser Permanente Northwest (KPNW) databases and mailed brochures inviting them to participate in the Life weight loss maintenance study. We also used employee newsletters, a member-directed website, and messages to employee email distribution lists to publicize the study. All outreach methods contained both a website address and a telephone number through which respondents could register for an information session. The website contained the same information as was provided by staff over the telephone.

Results: Out of 2122 potential participants who expressed interest in the study, 70% did so through the website. There was no difference in retention rates between enrollees who initiated contact through the website (WEB = 308) and enrollees who contacted the study by telephone (staff = 161). The WEB group was younger (p = 0.01), had higher income (p = 0.01) and education (p < 0.01) levels, and lower body mass index (BMI; p < 0.01). There was a trend toward greater weight loss in the WEB group (p = 0.06).

Limitations: We did not conduct a formal cost analysis of the two methods. Also, the population for this analysis was mostly Caucasian and middle income; thus, we cannot draw conclusions about the generalizability of our findings to more racially and economically diverse populations.

Conclusion: Enrolled participants who used a website to register for an initial study information session had similar study retention and outcome performance as enrollees who used a more traditional telephone method. For larger clinical trials, a website may help researchers more efficiently and cost-effectively achieve recruitment, eligibility, and randomization goals. More research is needed to determine whether similar recruitment and retention patterns are observed among racially and economically diverse populations when these and similar methods are compared.