SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes

Official title

SPARK: Smart Phone App for Gestational Diabetes Patients Supporting Key Lifestyle Behaviors and Glucose Control

Overview

Gestational diabetes mellitus (GDM) is an increasing public health challenge. Innovative, effective and scalable lifestyle interventions to support women with GDM to manage their disease and to prevent adverse obstetric and neonatal outcomes as well as later morbidity are requested.The aim of this project is to evaluate whether a novel, mobile health (mHealth) platform (SPARK) can improve self-management of GDM and prevent adverse maternal and offspring outcomes. SPARK is a multi-centre randomised controlled trial recruiting women diagnosed with GDM in South Eastern Sweden. Women will be randomised to the control or intervention group. All women will receive standard care. The intervention group will also receive support through the SPARK platform for healthy eating, physical activity and glycaemic control. Pregnancy outcomes are glycaemic control (primary), diet, physical activity, metabolic and inflammatory biomarkers in gestational week 36-37 as well as adverse obstetric and neonatal outcomes. Secondary outcomes also include cardiometabolic risk, physical activity and healthy eating behaviours one-year postpartum.

Interventions

• Behavioral SPARK
  The SPARK digital platform provides support to the patient (shown as an app) as well as provides the possibility for the health care provider to review and give feedback on blood glucose levels through the care giver interface of the platform.

Primary outcome measures

• Glucose control [Time frame: At the end of the intervention in gestational weeks 36-37]
• HbA1c [Time frame: At the end of the intervention in gestational weeks 36-37]

Secondary outcome measures (12)

• Diet intake quality using three dietary recalls by means of the Riksmaten Flex method [Time frame: At the end of the intervention in gestational weeks 36-37]
• Physical activity using accelerometry [Time frame: At the end of the intervention in gestational weeks 36-37]
• Incidence of pre-eclampsia [Time frame: Up to delivery]
• Incidence of Caesarean sections [Time frame: Up to delivery]
• Incidence of pregnancy induced hypertension [Time frame: Up to delivery]
• Metformin/insulin treatment [Time frame: Up to delivery]
• Preterm birth [Time frame: Up to delivery]
• Gestational weight gain [Time frame: From pre-prepregnancy up to 40 weeks of gestation]
• Infant birth weight [Time frame: At birth]
• Infant birth length [Time frame: At birth]
• Infant Apgar score [Time frame: At birth]
• Incidence of large-for gestational-age infant [Time frame: At birth]

Eligibility criteria

Inclusion criteria

• a confirmed diagnosis of GDM detected by oral glucose tolerance test in accordance with the World Health Organization guidelines

Exclusion criteria

• known pre-pregnancy diabetes
• twin pregnancy
• <18 years of age
• severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Sweden · 1 center

• Maternity health care, Region Östergötland — Linköping

Publications

• Lilliecreutz C, Soderstrom E, Ersson M, Bendtsen M, Brown V, Kaegi-Braun N, Linder R, Maddison R, Chisalita SI, Lof M. SPARK: an mHealth intervention for self-management and treatment of gestational diabetes mellitus in Sweden - protocol for a randomised controlled trial. BMJ Open. 2025 Mar 3;15(3):e089355. doi: 10.1136/bmjopen-2024-089355. PMID 40032379

Identifiers

NCT: NCT05348863 · 2021-03093

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗