Actively Recruiting
SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes
Led by Karolinska Institutet · Updated on 2025-01-22
360
Participants Needed
1
Research Sites
217 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Östergötland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A confirmed diagnosis of gestational diabetes mellitus detected by oral glucose tolerance test according to World Health Organization guidelines
- Female participants aged 18 to 50 years
You will not qualify if you...
- Known diabetes diagnosed before pregnancy
- Twin pregnancy
- Younger than 18 years old
- Severe co-morbidities limiting participation or previously diagnosed severe psychiatric illness
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maternity health care, Region Östergötland
Linköping, Sweden, 58185
Actively Recruiting
Research Team
M
Marie Löf, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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