Participant recruitment into a community-based diabetes prevention trial in India: Learnings from the Kerala Diabetes Prevention Program

Thirunavukkarasu Sathish, Zahra Aziz, Pilvikki Absetz, Kavumpurathu Raman Thankappan, Robyn Jennifer Tapp, Sajitha Balachandran, Suman Surendra Shetty, Brian Oldenburg

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Background: Data 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. Methods: The 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. Results: A 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. Conclusions: This study provides valuable information for future researchers planning to implement community-based diabetes prevention trials in India or other LMICs. Trial registration: Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

Original languageEnglish
Article number100382
Number of pages6
JournalContemporary Clinical Trials Communications
Publication statusPublished - 1 Sept 2019
Externally publishedYes


  • Challenges
  • Costs
  • Diabetes
  • India
  • Recruitment
  • Staff time

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