Community-based recruitment and enrollment for a clinical trial on the sensitive issue of fecal incontinence: the Fiber study.

The recruitment of community-living participants for clinical trials of sensitive topics, when the population is largely hidden and reluctant to self-identify, and the study protocols and procedures intensive, creates significant challenges to researchers. The Fiber Study is an ongoing randomized controlled clinical trial conducted to compare the effectiveness of three dietary fibers with different levels of fermentability for symptom management in community-living adults with fecal incontinence. The researchers developed a staged approach to recruitment using three primary recruitment methods and a three-phase approach to the enrollment process. We have been successful in reaching, recruiting, and enrolling participants in a clinical trial, as well as in effectively managing study resources and staff time.

Recruitment to mail and telephone interventions for obesity in a managed care environment: the Weigh-To-Be project.

OBJECTIVE: To evaluate the success of mail- and telephone-based weight loss programs in recruiting a representative sample of overweight members of a managed care organization (MCO). STUDY DESIGN: Cross-sectional. PATIENTS AND METHODS: A total of 1801 members of an MCO were recruited by direct mail, clinic flier, and physician referral for a research study evaluating mail- and telephone-based weight loss programs; 412 additional overweight members of the same MCO were identified in a general member survey for comparison purposes. Body mass index, demographics, diet, and exercise habits were measured. RESULTS: Study volunteers were heavier, more likely to be women, more likely to be minorities, more educated, and younger than the general sample of overweight members. They also had a more extensive history of dieting, ate a diet higher in fat and lower in fruit and vegetables, and were more likely to report binge eating than the general sample. However, study volunteers reported a higher level of physical activity. CONCLUSIONS: Invitations to participate in weight loss programs can attract large numbers of people in a managed care setting. However, the participation bias in recruitment to such programs is similar to that seen in traditional face-to-face interventions. Women of higher socioeconomic status who are severely obese and who have an extensive history of weight control efforts are more likely to participate. Additional research is needed to find ways to reach more men and older adults.