title: Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting.
abstract: OBJECTIVE
  To describe recruitment challenges in a randomized controlled translational trial (RCTT) of diabetes prevention in India.
  
  
  METHODS
  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).
  
  
  RESULTS
  Individuals from the community (n=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.
  
  
  CONCLUSIONS
  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.
authors: Madras Diabetes Research Foundation & Dr. Mohan's Diabetes Specialities Centre, Chennai, India. Electronic address: ranjani@mdrf.in.
authors: H
authors: H
authors: Ranjani
authors: Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
authors: M B
authors: MB
authors: Weber
authors: Madras Diabetes Research Foundation & Dr. Mohan's Diabetes Specialities Centre, Chennai, India.
authors: R M
authors: RM
authors: Anjana
authors: Madras Diabetes Research Foundation & Dr. Mohan's Diabetes Specialities Centre, Chennai, India.
authors: N
authors: N
authors: Lakshmi
authors: Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, USA.
authors: K M Venkat
authors: KMV
authors: Narayan
authors: Madras Diabetes Research Foundation & Dr. Mohan's Diabetes Specialities Centre, Chennai, India.
authors: V
authors: V
authors: Mohan
mesh_terms: D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000191:economics / Q000517:prevention & control*; D005260:Female; D006295:Health Resources / Q000600:supply & distribution; D006801:Humans; D007194:India / Q000453:epidemiology; D008019:Life Style; D008297:Male; D008875:Middle Aged; D050177:Overweight / Q000453:epidemiology / Q000523:psychology; D018579:Patient Selection; D011204:Poverty Areas; D011236:Prediabetic State / Q000191:economics / Q000453:epidemiology / Q000523:psychology; D055815:Young Adult
keywords: Challenges; Diabetes prevention; High risk; India; Prediabetes; Recruitment strategies