Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting. Issue 1 (October 2015)

• Record Type: Journal Article
• Authors: Ranjani, H.; Weber, M.B.; Anjana, R.M.; Lakshmi, N.; Venkat Narayan, K.M.; Mohan, V.
• Is Part Of: Diabetes research and clinical practice. Volume 110:Issue 1(2015)
• Page Start: 51
• Page End: 59
• Publication Date: 2015-10
• Subjects: Diabetes -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462
• DOI: 10.1016/j.diabres.2015.07.013
• Languages: English
• ISSNs: 0168-8227

Abstract

<abstract abstract-type="author" id="abs0005"> <title id="sect0005">Abstract</title> <sec> <title id="sect0010">Aim</title> <p id="spar0005">To describe recruitment challenges in a randomized controlled translational trial (RCTT) of diabetes prevention in India.</p> </sec> <sec> <title id="sect0015">Methods</title> <p id="spar0010">The Diabetes Community Lifestyle Improvement Program (D-CLIP) is a RCTT, comparing standard of care to a step-wise model of diabetes prevention. Overweight adults with prediabetes were identified through a two-step screening process (1) field-based screening: minimal testing with a random capillary glucose measurement and (2) clinic-based screening including an Oral Glucose Tolerance Test (OGTT).</p> </sec> <sec> <title id="sect0020">Results</title> <p id="spar0015">Individuals from the community (<italic>n</italic> = 19377) were screened at residential locations, offices, educational institutions, places of worship, parks and beaches. Of these, 3535 (18.2%) 'high-risk' participants based on capillary glucose values were eligible for step 2 screening with OGTT. However, only 21.5% participated. An additional 521 participants directly entered step 2 via direct referrals from our clinical/research databases, study participant referrals and targeted advertisements. Of the 1285 individuals who underwent an OGTT, 710 (55.3%) were eligible for randomization, and 602 (84.8%) were randomized into the trial. The ratio of participants entering from step 1 to step 2 was 25:1 (3.9%) and from step 2 to randomization 2:1 (47%). Average staff time for recruitment was 350 h per week for an 11-person team.</p> </sec> <sec> <title id="sect0025">Conclusions</title> <p id="spar0020">Nearly 55 people needed to be screened with a questionnaire plus capillary glucose test to randomize one participant with prediabetes. Using a 2-step strategy requires additional staff time, but considerably reduces the need for OGTT's, thereby minimizing participant burden and study costs.</p> </sec> </abstract>