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

NCT ID: NCT05348863

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-28
• Study Completion Date: 2026-12-30

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.

Conditions

Gestational Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SPARK app

Access to the SPARK app which will provide support for a healthier diet and increased physical activity as well as daily monitoring of blood glucose levels.

Group Type: EXPERIMENTAL

SPARK

Intervention Type: BEHAVIORAL

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.

Control arm

Standard care i.e., the routine treatment program for GDM delivered by the care provider.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Region Östergötland

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Marie Löf, docent

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Löf, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Maternity health care, Region Östergötland

Linköping, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Marie Löf, Professor

Role: CONTACT

marie.lof@ki.se

+46 734 426417

Facility Contacts

Caroline Lilliecreutz, MD, Associate professor

Role: primary

References

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.

Reference Type: DERIVED

PMID: 40032379 (View on PubMed)

Other Identifiers

2021-03093

Identifier Type: -

Identifier Source: org_study_id