Contemporary Clinical Trials Communications (Jun 2021)
Design and strategies used for recruitment and retention in a double blind randomized controlled trial investigating the effects of soluble corn fiber on bone indices in pre-adolescent children (PREBONE-Kids study) in Malaysia
Abstract
Background: Recruitment and retention in longitudinal nutrition intervention studies among children is challenging and scarcely reported. This paper describes the strategies and lessons learned from a 1-year randomized double-blind placebo-controlled trial among pre-adolescent children on the effects of soluble corn fiber (SCF) on bone indices (PREBONE-Kids). Methods: Participants (9–11 years old) were recruited and randomized into 4 treatment groups (600 mg calcium, 12 g SCF, 12 g SCF plus 600 mg calcium and placebo). Interventions were consumed as a fruit-flavored powdered drink for 1-year. School-based recruitment was effective due to support on study benefits from parents and teachers, peer influence and a 2-weeks study run-in for participants to assess their readiness to commit to the study protocol. Retention strategies focused on building rapport through school-based fun activities, WhatsApp messaging, providing health screening and travel reimbursements for study measurements. Compliance was enhanced by providing direct on-site school feeding and monthly non-cash rewards. Choice of 2 flavors for the intervention drinks were provided to overcome taste fatigue. Satisfaction level on the manner in which the study was conducted was obtained from a voluntary sub-set of participants. Results: The study successfully enrolled 243 participants within 6 months and retained 82.7% of the participants at the end of 1 year, yielding a drop-out rate of 17.3%. Compliance to the intervention drink was 85% at the start and remained at 78.7% at the end of 1 year. More than 95% of the participants provided good feedback on intervention drinks, rapport building activities, communication and overall study conduct. Conclusion: Successful strategies focused on study benefits, rapport building, frequent communication using social media and non-cash incentives helped improved compliance and retention rate. The lessons learned to maintain a high retention and compliance rate in this study provide valuable insights for future studies in a similar population.
