Mobile app plus group sessions showed feasibility in Malaysian women with gestational diabetes

This feasibility randomized controlled trial evaluated a digital health intervention among 60 women with gestational diabetes mellitus in Malaysia. The study population consisted of women who were eligible for the trial, from which 60 (9%) consented and were randomised out of 294 eligible participants. The intervention comprised mobile application modules addressing diet, physical activity, and mental health, combined with dietitian-led group sessions and motivational text messages. The comparator group received usual gestational diabetes care.

The primary outcome measured feasibility metrics, including consent, eligibility, randomisation, and provision of outcome data. Secondary outcomes included biomedical and mental health measures. At each follow-up, 85% of participants completed biomedical outcomes. The study followed participants for 6.0 months. No treatment effect was observed for biomedical outcomes or mental health outcomes. Absolute numbers for these secondary results were not reported.

Safety and tolerability data were not reported, and discontinuations were not reported. The study was a feasibility trial, meaning effectiveness is unclear. Key limitations include the feasibility-only design and the absence of reported adverse events. The primary outcomes were feasibility metrics rather than clinical efficacy. Funding or conflicts of interest were not reported.

The practice relevance suggests feasibility to conduct a full-scale RCT. However, the effectiveness of diabetes prevention interventions post-GDM in this setting is unclear. The study does not establish causality for the intervention on biomedical or secondary outcomes.