Pilot randomized trial of cash transfer interventions to improve health outcomes in low income adults with poorly controlled type 2 diabetes: Study protocol and baseline characteristics

Background: Monetary interventions, such as cash transfers, have emerged as important intervention approaches to address the complex determinants at the structural and individual level impacting diabetes outcomes. Methods: This NIH funded (K01DK131319), pilot randomized controlled trial (RCT) is an ongoing 5 year study to evaluate the efficacy of two diabetes-tailored cash transfer interventions in low-income adults in which 1) cash transfers are conditional on participating in nurse-led, telephone-delivered diabetes education/skills training and stress/coping intervention delivered every 2 weeks for 6 months (DM-CCT); or 2) cash transfers are unconditional (DM-UCT), on clinical outcomes (HbA1c and blood pressure), and quality of life among 100 African Americans aged 18+ years with T2DM and HbA1c ≥8 %. Assessments will be conducted at baseline, 3-, and 6-months with primary outcome at 6 months post-randomization. Discussion: Recruitment began in March 2023 and was completed in February 2024. Average age was 51 years. Most participants were women (71.0 %). Mean HbA1c was 10.1±1.8 for DM-CCT group and 10.2±1.8 for DM-UCT group. Mean systolic and diastolic blood pressure was 128.0±22.7 mmHg and 80.2±13.7 mmHg for DM-CCT group and 133.5±22.2 mmHg and 83.7±13.7 mmHg for DM-UCT group. Mean BMI was 36.2±10.3 kg/m² for DM-CCT and 35.7±9.2 kg/m² for DM-UCT. This pilot RCT represents a promising intervention to address the underlying poverty driven social risk factors while simultaneously addressing diabetes specific behaviors to improve outcomes. Findings from this study will provide preliminary evidence on efficacy of cash transfer interventions to improve clinical outcomes in low-income adults with poorly controlled T2DM.