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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Glucose control [Срок оценки: At the end of the intervention in gestational weeks 36-37]
• HbA1c [Срок оценки: At the end of the intervention in gestational weeks 36-37]

Вторичные конечные точки (12)

• Diet intake quality using three dietary recalls by means of the Riksmaten Flex method [Срок оценки: At the end of the intervention in gestational weeks 36-37]
• Physical activity using accelerometry [Срок оценки: At the end of the intervention in gestational weeks 36-37]
• Incidence of pre-eclampsia [Срок оценки: Up to delivery]
• Incidence of Caesarean sections [Срок оценки: Up to delivery]
• Incidence of pregnancy induced hypertension [Срок оценки: Up to delivery]
• Metformin/insulin treatment [Срок оценки: Up to delivery]
• Preterm birth [Срок оценки: Up to delivery]
• Gestational weight gain [Срок оценки: From pre-prepregnancy up to 40 weeks of gestation]
• Infant birth weight [Срок оценки: At birth]
• Infant birth length [Срок оценки: At birth]
• Infant Apgar score [Срок оценки: At birth]
• Incidence of large-for gestational-age infant [Срок оценки: At birth]

Критерии участия

Критерии включения

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

Критерии исключения

• known pre-pregnancy diabetes
• twin pregnancy
• <18 years of age
• severe co-morbidities that would limit participation or a previously diagnosed severe psychiatric illness.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Швеция · 1 центр

• Maternity health care, Region Östergötland — Linköping

Публикации

• Lilliecreutz C, Soderstrom E, Ersson M, Bendtsen M, Brown V, Kaegi-Braun N, Linder R, Maddison R, Chisalita SI, Lof M. SPARK: an mHealth intervention for self-management and treatment of gestational diabetes mellitus in Sweden - protocol for a randomised controlled trial. BMJ Open. 2025 Mar 3;15(3):e089355. doi: 10.1136/bmjopen-2024-089355. PMID 40032379

Идентификаторы

NCT: NCT05348863 · 2021-03093

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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