A digital health-supported community pharmacy-based lifestyle intervention program for overweight or obese adults with prediabetes, the PRediabetes Intervention, Management and Evaluation (PRIME) Program: A cluster randomized controlled trial

Abstract

Background: Evidence on the impact of using digital health tools to facilitate prediabetes management in community pharmacies is lacking. This study aimed to evaluate the effects of a digital health-supported and community pharmacy-based lifestyle intervention (PRIME) program on individuals with prediabetes in Malaysia.

Methods: A two-arm cluster randomised controlled trial was conducted in 16 community pharmacies from two states in Malaysia and included people with prediabetes that were overweight or obese. The intervention group received support of in-depth counselling from pharmacists, in-app prediabetes education modules, and peer support, while the usual care group received counselling based on pharmacists' usual practice. The primary outcomes were the proportion of participants achieving ≥5 % weight loss and differential change in weight. All analyses were performed using intention to treat analyses with mixed effect modelling.

Findings: Ninety-one participants (intervention, n = 46; usual care n = 45) were recruited. At the end of study, participants in the intervention group were twice as likely compared to the usual care group to report a minimum 5 % weight loss (21 % intervention and 7.5 % usual care participants, odds ratio: 2.5, p = 0.266). Intervention group participants also reported a larger weight loss, with a mean difference of 1.26 kg (95 %CI -2.36 kg to -0.15 kg) between groups. These differences were more significant especially among those who were more engaged with PRIME.

Conclusion: The intervention showed greater weight loss than the usual care, but the proportion of individuals achieving clinically meaningful weight loss (≥5 %) was not significant. PRIME program can be an important and useful tool to improve risk factors among individuals with prediabetes especially in a low-resource setting. Further research is needed to determine the economic and long-term sustainability of such programs.

Keywords: Behaviour; Clinical trials; Diabetes; Epidemiology; Primary prevention; eHealth.