Clinical trial NCT05348863: SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes
Official title: SPARK: Smart Phone App for Gestational Diabetes Patients Supporting Key Lifestyle Behaviors and Glucose Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Östergötland
name: Linkoeping University
First posted: 2022-04-27
Enrollment: 360
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Glucose control
timeFrame: At the end of the intervention in gestational weeks 36-37
measure: HbA1c
timeFrame: At the end of the intervention in gestational weeks 36-37
Secondary outcomes:
measure: Diet intake quality using three dietary recalls by means of the Riksmaten Flex method
timeFrame: At the end of the intervention in gestational weeks 36-37
measure: Physical activity using accelerometry
timeFrame: At the end of the intervention in gestational weeks 36-37
measure: Incidence of pre-eclampsia
timeFrame: Up to delivery
measure: Incidence of Caesarean sections
timeFrame: Up to delivery
measure: Incidence of pregnancy induced hypertension
timeFrame: Up to delivery
measure: Metformin/insulin treatment
timeFrame: Up to delivery
measure: Preterm birth
timeFrame: Up to delivery
measure: Gestational weight gain
timeFrame: From pre-prepregnancy up to 40 weeks of gestation
measure: Infant birth weight
timeFrame: At birth
measure: Infant birth length
timeFrame: At birth
measure: Infant Apgar score
timeFrame: At birth
measure: Incidence of large-for gestational-age infant
timeFrame: At birth
measure: Infant shoulder dystocia
timeFrame: At birth
measure: Infant hypoglycaemia
timeFrame: At birth
measure: Glucose control
timeFrame: From inclusion (baseline) to end of intervention in gestational week 36-37
measure: Glycaemic variability I
timeFrame: At the end of the intervention in gestational week 36-37
measure: Glycaemic variability II
timeFrame: At the end of the intervention in gestational week 36-37
measure: Delivery complications
timeFrame: At delivery
measure: Hospital stay
timeFrame: The first week post partum
measure: Glucose- insulin treatment during delivery
timeFrame: During delivery
measure: Metabolic and inflammatory biomarkers I
timeFrame: At gestational weeks 36-37
measure: Metabolic and inflammatory biomarkers II
timeFrame: At gestational weeks 36-37
measure: Metabolic and inflammatory biomarkers III
timeFrame: At gestational week 36-37
measure: Metabolic and inflammatory biomarkers IV
timeFrame: At gestational week 36-37
measure: Metabolic and inflammatory biomarkers V
timeFrame: At gestational week 36-37
measure: Maternal cardiometabolic risk profile
timeFrame: One year post partum
measure: Diet intake quality using three dietary recalls by means of the Riksmaten Flex method
timeFrame: One year post partum
measure: Physical activity using accelerometry
timeFrame: One year post partum
measure: Metabolic and inflammatory biomarkers VI
timeFrame: At gestational week 36-37
measure: Glycaemic variability III
timeFrame: Full intervention period (up to 3 months)
measure: Microvascular function I
timeFrame: One year post partum
measure: Microvascular function II
timeFrame: One year post partum
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Maternity health care, Region Östergötland
Study officials:
affiliation: Karolinska Institutet
name: Marie Löf, Professor
role: PRINCIPAL_INVESTIGATOR
References: