• Thirunavukkarasu Sathish, Zahra Aziz, Pilvikki Absetz, Kavumpurathu Raman Thankappan, Robyn Jennifer Tapp, Sajitha Balachandran, Suman Surendra Shetty, and Brian Oldenburg.
• Melbourne School of Population and Global Health, The University of Melbourne, 235 Bouverie St, Carlton, VIC, 3053, Australia.
• Contemp Clin Trials Commun. 2019 Sep 1; 15: 100382.

BackgroundData on participant recruitment into diabetes prevention trials are limited in low- and middle-income countries (LMICs). We aimed to provide a detailed analysis of participant recruitment into a community-based diabetes prevention trial in India.MethodsThe Kerala Diabetes Prevention Program was conducted in 60 polling areas (electoral divisions) of the Neyyatinkara taluk (subdistrict) in Trivandrum district, Kerala state. Individuals (age 30-60 years) were screened with the Indian Diabetes Risk Score (IDRS) at their homes followed by an oral glucose tolerance test (OGTT) at community-based clinics. Individuals at high-risk of developing diabetes (IDRS score ≥60 and without diabetes on the OGTT) were recruited.ResultsA total of 1007 participants (47.2% women) were recruited over nine months. Pilot testing, personal contact and telephone reminders from community volunteers, and gender matching of staff were effective recruitment strategies. The major recruitment challenges were: (1) during home visits, one-third of potential participants could not be contacted, as they were away for work; and (2) men participated less frequently in the OGTT screening than women (75.2% vs. 84.2%). For non-participation, lack of time (42.0%) was most commonly cited followed by 'I am already feeling healthy' (30.0%), personal reasons (24.0%) and 'no benefit to me or my family' (4.0%). An average of 17 h were spent to recruit one participant with a cost of US$23. The initial stage of screening and recruitment demanded higher time and costs.ConclusionsThis study provides valuable information for future researchers planning to implement community-based diabetes prevention trials in India or other LMICs.Trial RegistrationAustralia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

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