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

NCT05348863 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-01-22

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Region Östergötland

    collaborator OTHER

  • Linkoeping University

    collaborator OTHER_GOV

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Marie Löf, Professor · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-28
Primary Completion
2025-12-31
Completion
2026-12-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05348863 on ClinicalTrials.gov