SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes
ConditionGestational Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorKarolinska Institutet
About this trial
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
This trial accepts healthy volunteersQualifiers
a confirmed diagnosis of GDM detected by oral glucose tolerance test in accordance with the World Health Organization guidelines
Disqualifiers
known pre-pregnancy diabetes
twin pregnancy
<18 years of age
severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.
Trial design
Design model
Parallel
Treatments tested in this trial
SPARK
BehavioralThe 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.
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: SPARK appExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Glucose control
Time in Range percent of time for glucose levels within clinical target levels using continous glucose monitoring
Time frame
At the end of the intervention in gestational weeks 36-372
HbA1c
Glycosylated hemoglobulin
Time frame
At the end of the intervention in gestational weeks 36-37Secondary outcomes
1
Diet intake quality using three dietary recalls by means of the Riksmaten Flex method
Diet intake quality will be assessed using three 24 hour dietary recalls by means of the Riksmaten Flex web-based dietary recall method.
Time frame
At the end of the intervention in gestational weeks 36-372
Physical activity using accelerometry
Time spent on physical activity at different levels (sedentary, light, moderate, vigorous) in minutes per day will be assessed using accelerometry collected during 7 days
Time frame
At the end of the intervention in gestational weeks 36-373
Incidence of pre-eclampsia
Diagnosis of pre-eclampsia
Time frame
Up to delivery4
Incidence of Caesarean sections
Delivery by caesarean sections
Time frame
Up to deliverySponsors and contacts
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Source ClinicalTrials.gov