The effect of a community-based health behaviour intervention on health-related quality of life in people with Type 2 diabetes in Nepal: a Cluster Randomized Controlled Trial

Purpose: Little is known about the effectiveness of health behaviour intervention in improving health-related quality of life (HRQOL) despite HRQOL being an important outcome in Type 2 diabetes (T2DM) management. This study examined the effectiveness of a culturally appropriate health behavioural intervention in improving HRQOL of people with T2DM in Nepal. Methods: A cluster randomized controlled trial was conducted among 481 people with T2DM from 30 randomly selected healthcare facilities in Kavrepalanchok and Nuwakot districts. The intervention group received 12 culturally tailored and group-based intervention sessions for six months whereas, the control group received usual care. The primary outcomes of this study were changes in the EuroQOL (EQ5D-3L) index score and EuroQOL visual analogue scale (EQVAS) score between baseline and six-month post-intervention. The intervention effect was assessed using generalized estimating equation models. Results: At six-months post-intervention, there was a positive and statistically significant effect on EQVAS (β₁ = 3.61, 95%CI: 0.05, 7.17) in the intervention group compared to control group. No statistically significant effect was observed in EQ5D-3L index score. A statistically significant increase in EQVAS score of 0.5 was observed per session attended by the study participants (β₁ = 0.49, 95%CI: 0.01, 0.98). Conclusion: The health behaviour intervention led to improved HRQOL. An increase in the number of intervention sessions attended was significantly associated with higher EQVAS scores, emphasizing the need for longer-term and engaging interventions that are well adhered to. Longer term assessment of change in HRQOL outcomes are needed when actual changes in HRQOL are more likely to be observed. Trial registration: Australia and New Zealand Clinical Trial Registry (ACTRN12621000531819).