Effectiveness of a group-based Diabetes Prevention Education Program (DiPEP) in a population with pre-diabetes: A cluster randomised controlled trial in Nepal

Abstract

Background Although several lifestyle intervention studies have been conducted in low/middle-income countries, there were no such studies in Nepal. Therefore, a group-based culturally tailored Diabetes Prevention Education Program (DiPEP) was conducted recently. The study aimed to evaluate the effect of DiPEP in glycated haemoglobin (HbA1c), weight, waist circumference, physical activity and diet among population with pre-diabetes. Method A two-arm cluster randomised controlled trial was conducted in 12 clusters of two urban areas in Nepal. The DiPEP was a 6 month intervention (four 1-hour weekly educational sessions and 5 months of follow-up by community health workers/volunteers (CHW/Vs)). A postintervention assessment was done after 6 months. Linear mixed model was used to estimate the mean difference in primary outcome (HbA1c) and secondary outcomes (weight, waist circumference, physical activity and diet) between intervention and control arms, adjusted for baseline measure. Results In intention-to-treat analysis with a total of 291 participants, the estimated mean difference in HbA1c was found to be 0.015 percentage point (95% CI -0.074 to 0.104) between the intervention arm and the control arm, while it was -0.077 (95% CI -0.152 to -0.002) among those who attended at least 3 out of 4 educational sessions. The estimated mean difference in weight (in participants who attended ≥1 educational session) was -1.6 kg (95% CI -3.1 to -0.1). A significantly lower grain consumption was found in intervention arm (-39 g/day, 95% CI -65 to -14) compared with the control arm at postintervention assessment. Conclusion Although compliance was affected by COVID-19, individuals who participated in ≥3 educational sessions had significant reduction in HbA1c and those who attended ≥1 educational session had significant weight reduction. Grain intake was significantly reduced among the intervention arm than the control arm. Hence, group-based lifestyle intervention programmes involving CHW/vs is recommended for diabetes prevention. Trial registration number NCT04074148.