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

Ranjani, H and Weber, M B and Anjana, R M and Lakshmipriya, N and Venkat Narayan, K M and Mohan, V (2015) Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting. Diabetes Research and Clinical Practice, 110 (1). p. 51. ISSN 01688227

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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.

Item Type:Article
Official URL/DOI:
Uncontrolled Keywords:Challenges; Diabetes prevention; High risk; India; Prediabetes; Recruitment strategies
Subjects:Diabetes > Diabetes Risk Factors
Diabetes Epidemiology
Divisions:Department of Epidemiology
Department of Diabetology
ID Code:961
Deposited By:surendar radha
Deposited On:07 Jan 2016 12:47
Last Modified:07 Jan 2016 12:47

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