title: Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.
abstract: The promotion of a healthy diet, physical activity and measurement of blood glucose levels are essential components in the care for women with gestational diabetes mellitus (GDM). Smartphones offer a new way to promote health behaviour. The main aim is to investigate if the use of the Pregnant+ app, in addition to standard care, results in better blood glucose levels compared with current standard care only, for women with GDM.
  
  
  
  This randomised controlled trial will include 230 pregnant women with GDM followed up at 5 outpatient departments (OPD) in the greater Oslo Region. Women with a 2-hour oral glucose tolerance test (OGTT) ≥9 mmol/L, who own a smartphone, understand Norwegian, Urdu or Somali and are <33 weeks pregnant, are invited. The intervention group receives the Pregnant+ app and standard care. The control group receives standard care only. Block randomisation is performed electronically. Data are collected using self-reported questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. Groups will be compared using linear regression for the main outcome and χ2test for categorical data and Student's t-test or Mann-Whitney-Wilcoxon test for skewed distribution. The main outcome is the glucose level measured at the 2-hour OGTT 3 months postpartum. Secondary outcomes are a change in health behaviour and knowledge about GDM, quality of life, birth weight, mode of delivery and complications for mother and child.
  
  
  
  The study is exempt from regional ethics review due to its nature of quality improvement in patient care. Our study has been approved by the Norwegian Social Science Data Services and the patient privacy protections boards governing over the recruitment sites. Findings will be presented in peer-reviewed journals and at conferences.
  
  
  
  NCT02588729, Post-results.
authors.affiliation: Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
authors.forename: Iren
authors.initials: I
authors.lastname: Borgen
authors.affiliation: Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
authors.forename: Lisa Maria
authors.initials: LM
authors.lastname: Garnweidner-Holme
authors.affiliation: University of Oslo, Oslo, Norway.
authors.forename: Anne Flem
authors.initials: AF
authors.lastname: Jacobsen
authors.affiliation: Division of Medicine, Section of Dietetics, Oslo University Hospital, Oslo, Norway.
authors.forename: Kirsti
authors.initials: K
authors.lastname: Bjerkan
authors.affiliation: University Graduate Centre, Kjeller, Norway.
authors.forename: Seraj
authors.initials: S
authors.lastname: Fayyad
authors.affiliation: Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
authors.forename: Pål
authors.initials: P
authors.lastname: Joranger
authors.affiliation: Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Lilleengen
authors.affiliation: The Norwegian Knowledge Centre for the Health Services, Oslo, Norway.
authors.forename: Annhild
authors.initials: A
authors.lastname: Mosdøl
authors.affiliation: University Graduate Centre, Kjeller, Norway.
authors.forename: Josef
authors.initials: J
authors.lastname: Noll
authors.affiliation: Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
authors.forename: Milada Cvancarova
authors.initials: MC
authors.lastname: Småstuen
authors.affiliation: Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
authors.forename: Laura
authors.initials: L
authors.lastname: Terragni
authors.affiliation: Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
authors.forename: Liv Elin
authors.initials: LE
authors.lastname: Torheim
authors.affiliation: Faculty of Health Sciences, Oslo and Akershus University College of Applied Sciences, Oslo, Norway.
authors.forename: Mirjam
authors.identifier: 0000-0002-9873-4023
authors.initials: M
authors.lastname: Lukasse
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000378:metabolism; D001786:Blood Glucose / Q000378:metabolism*; D002985:Clinical Protocols; D016640:Diabetes, Gestational; D000072001:Diet, Healthy; D015444:Exercise; D005260:Female; D005951:Glucose Tolerance Test; D007722:Health Knowledge, Attitudes, Practice; D006293:Health Promotion; D006801:Humans; D063731:Mobile Applications / Q000706:statistics & numerical data; D009664:Norway / Q000453:epidemiology; D011247:Pregnancy; D037841:Pregnant People; D015397:Program Evaluation; D000068997:Smartphone / Q000706:statistics & numerical data; D016387:Women's Health
chemical_list: D015415:Biomarkers; D001786:Blood Glucose
keywords: diet; gestational diabetes mellitus; physical activity; pregnancy; randomized controlled trial; smartphone application