SPARK: an mHealth intervention for self-management and treatment of gestational diabetes mellitus in Sweden - protocol for a randomised controlled trial

Abstract

Introduction: Gestational diabetes mellitus (GDM) is increasingly becoming a serious public health challenge. Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their condition and prevent adverse obstetric and neonatal outcomes as well as later morbidity are required. This study aims to evaluate whether a novel, multilingual and scalable mobile health (mHealth) intervention (SPARK; SmartPhone App for gestational diabetes patients suppoRting Key lifestyle behaviours and glucose control) can improve self-management and treatment of GDM and prevent adverse maternal and offspring outcomes.

Methods/analyses: SPARK is a multicentre two-arm randomised controlled trial recruiting women diagnosed with GDM in south-eastern Sweden. A total of 412 women will be randomised to either standard care (control) or the SPARK intervention. The SPARK online platform (accessed through a mobile app) provides a behaviour change programme for healthy eating, physical activity and glycaemic control. To increase reach, SPARK is available in Swedish, English, Arabic and Somali. SPARK also comes with a clinician portal where healthcare professionals monitor and intervene when glycaemic control is unsatisfactory (above certain cut-offs). Primary outcomes are glycaemic control that is, time in range and HbA1c, while diet, physical activity (ActiGraph), gestational weight gain, metabolic and inflammatory biomarkers in weeks 37-38, adherence to protocol for daily glucose sampling, as well as adverse obstetric and neonatal outcomes are secondary outcomes. Secondary outcomes also include cardiometabolic risk evaluation, physical activity and healthy eating behaviours 1 year postpartum. A health economic evaluation of SPARK vs standard care will also be conducted.

Ethics and dissemination: This study has been approved by the Swedish Ethical Review Authority (2021-06627-01; 2022-03842-02; 2023-05911-02). Results will be disseminated through scientific papers in peer-reviewed journals, posts in traditional and social media, and presentations at scientific and healthcare professionals' conferences.

Trial registration number: This trial was registered at the ClinicalTrials.gov register platform (ID NCT05348863) 27 April 2022.

Keywords: Behavior; Cardiovascular Disease; Diabetes in pregnancy; Maternal medicine; Randomized Controlled Trial; eHealth.

Figure 1. Study outline for the SPARK randomised controlled trial.

Figure 2. The SPARK user interface (app) for the patients showing examples from (a) the home (starting) page; (b) blood glucose monitoring using a glucometer automatically transferred via Bluetooth with instant feedback and graphs visualising values over time; and (c) interventional content to support healthy eating and physical activity.