Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting

• Published in: Diabetes research and clinical practice Vol. 110; no. 1; pp. 51 - 59
• Main Authors: Ranjani, H, Weber, M.B, Anjana, R.M, Lakshmi, N, Venkat Narayan, K.M, Mohan, V
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier B.V 01.10.2015
• Subjects: Adult; Aged; Challenges; Diabetes Mellitus, Type 2 - economics; Diabetes Mellitus, Type 2 - prevention & control; Diabetes prevention; Endocrinology & Metabolism; Female; Health Resources - supply & distribution; High risk; Humans; India; India - epidemiology; Life Style; Male; Middle Aged; Overweight - epidemiology; Overweight - psychology; Patient Selection; Poverty Areas; Prediabetes; Prediabetic State - economics; Prediabetic State - epidemiology; Prediabetic State - psychology; Recruitment strategies; Young Adult; India; High risk; Prediabetes; Diabetes prevention; Recruitment strategies; Challenges; India
• ISSN: 0168-8227; 1872-8227
• DOI: 10.1016/j.diabres.2015.07.013

Abstract Aim 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.