BACKGROUND: Women with a history of gestational diabetes mellitus (GDM) are at an increased risk of developing type 2 diabetes mellitus (T2DM). Lifestyle interventions aimed at postpartum weight loss to reduce T2DM risk have been reported, but poor compliance remains a barrier. Smartphone-based interventions may improve compliance, but data on its use in women with recent GDM are limited. OBJECTIVE: This trial aimed to investigate the efficacy of a smartphone app in restoring optimal weight following delivery in women with GDM, in the setting of a population with high rates of GDM and type 2 diabetes. METHODS: In this unblinded randomized controlled trial, 200 women with GDM were randomized to receive the intervention or standard care following delivery. The intervention enabled logging of weight, meals, and activity, with web-based interaction with a team comprising dieticians, a physiotherapist, and an occupational therapist. The primary outcome was an achievement of optimal weight (defined as the restoration of first trimester weight if first trimester BMI <= 23 kg/m2 or weight loss of at least 5% from first trimester weight if first trimester BMI > 23 kg/m2) at 4 months post partum. Secondary outcome measures included absolute weight loss, serum metabolic markers, self-reported nutritional intake, health education, and quality of life via questionnaires and user engagement in the intervention group. RESULTS: In total, 40% (38/96) of women in the intervention group achieved optimal weight at 4 months post delivery compared with 32% (28/93) in the control group (p = 0.27). Compared with the control group, women in the intervention group reported significantly reduced caloric intake at 4 months after delivery (p < 0.001) and higher health-directed behavior scores (p = 0.045). The intervention group also reported increased emotional distress scores (p = 0.01). At 4 months, participant engagement with the intervention was maintained at 60.8% (SD 33.9%). CONCLUSIONS: Although a statistically significant increase in women achieving healthy weight was not observed, this app remains promising, as women in the intervention group reported improved health behaviors and lower caloric intake. Importantly, the high retention rates suggest that a larger study with a longer follow-up period might confirm the effectiveness of this app for weight management. TRIAL REGISTRATION: ClinicalTrials.gov NCT03324737; https://ClinicalTrials.gov/ct2/show/NCT03324737. International Registered Report Identifier (IRRID) RR2-10.1186/s12889-019-7691-3.

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