1. Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting.
- Author
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Ranjani, H., Weber, M.B., Anjana, R.M., Lakshmi, N., Venkat Narayan, K.M., Mohan, V., and Narayan, K M Venkat
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DIABETES prevention , *OVERWEIGHT persons , *PREDIABETIC state , *PEOPLE with diabetes , *MEASUREMENT of glucose in the body , *GLUCOSE tolerance tests , *TYPE 2 diabetes prevention , *OBESITY & psychology , *TYPE 2 diabetes , *POVERTY areas , *COMPARATIVE studies , *RESEARCH methodology , *MEDICAL care use , *MEDICAL cooperation , *OBESITY , *RESEARCH , *EVALUATION research , *LIFESTYLES , *PATIENT selection , *PSYCHOLOGY , *ECONOMICS - 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. [ABSTRACT FROM AUTHOR]- Published
- 2015
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