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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

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

Locations
Other Locations
Sweden
Maternity health care, Region Östergötland
RECRUITING
Linköping
Contact Information
Primary
Marie Löf, Professor
marie.lof@ki.se
+46 734 426417
Time Frame
Start Date: 2022-10-28
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 360
Treatments
Experimental: 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.
No_intervention: Control arm
Standard care i.e., the routine treatment program for GDM delivered by the care provider.
Related Therapeutic Areas
Sponsors
Collaborators: Linkoeping University, Region Östergötland
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov