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Randomized Controlled Trial
. 2011 Jan;32(1):40-9.
doi: 10.1016/j.cct.2010.10.006. Epub 2010 Oct 23.

Healthy Living Partnerships to Prevent Diabetes: recruitment and baseline characteristics

Caroline S Blackwell  1 , Kara A Foster, Scott Isom, Jeffrey A Katula, Mara Z Vitolins, Erica L Rosenberger, David C Goff Jr
Affiliations
Randomized Controlled Trial

Healthy Living Partnerships to Prevent Diabetes: recruitment and baseline characteristics

Caroline S Blackwell et al. Contemp Clin Trials. 2011 Jan.

Abstract

Healthy Living Partnerships to Prevent Diabetes (HELP PD) is a randomized controlled trial designed to translate the Diabetes Prevention Program (DPP) lifestyle intervention into a community setting using community health workers engaged through an existing Diabetes Care Center (DCC). Overweight and obese (BMI 25-40 kg/m²) individuals with pre-diabetes (fasting blood glucose 95-125 mg/dl) with no medical contraindications to participate in a lifestyle intervention were recruited for participation in this study. Standard recruitment strategies were employed, including mass mailing, direct provider referral, and community events. Participant recruitment and randomization for this trial began in 2007 and was concluded in 2009. 1818 screenings were conducted; of these, 326 (17.9%) qualified and 301 (16.6%) participants were randomized over a 21 month period. 23.8% of potential participants were excluded during the initial telephone screening, primarily for BMI and recent history of CVD. The majority of participants (220, 73.1%) reported mass mailing as their primary source of information about the study. Mass mailing was more effective with participants who identified themselves as white when compared to African-Americans. The cost of recruitment per randomized participant was $816, which includes direct costs and staff effort. 41% of the randomized participants were male and approximately 27% reported a race or ethnicity other than white. In comparison to the DPP study cohort, the HELP PD population is older, more educated and predominately white. These differences, reflecting in part the community in which HELP PD was conducted, may have implications for retention and adherence in the lifestyle intervention group.

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Figures

Figure 1
Figure 1
Cumulative number randomized versus study goal for randomization period (August 2007- August 2009) in the HELP PD study.
Figure 2
Figure 2
Screening flow through randomization, including exclusion criteria for HELP PD.
Figure 2
Figure 2
Screening flow through randomization, including exclusion criteria for HELP PD.
See this image and copyright information in PMC

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