NCT05348863 SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes
| NCT ID | NCT05348863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Gestational Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2022-10-28 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2022-10-28 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Marie Löf, Professor
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT05348863 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Gestational Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05348863 currently recruiting?
Yes, NCT05348863 is actively recruiting participants. Contact the research team at marie.lof@ki.se for enrollment information.
Where is the NCT05348863 trial being conducted?
This trial is being conducted at Linköping, Sweden.
Who is sponsoring the NCT05348863 clinical trial?
NCT05348863 is sponsored by Karolinska Institutet. The principal investigator is Marie Löf, Professor at Karolinska Institutet. The trial plans to enroll 360 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.