Clinical trial NCT02588729: A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With GDM - RCT
Official title: A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With Gestational Diabetes Mellitus - RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational diabetes
app
RCT
diet
physical activity
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Universitetssenteret på Kjeller
name: Oslo University Hospital
name: Vestre Viken Hospital Trust
name: University Hospital, Akershus
name: The Norwegian Centre for Minority Health Research
First posted: 2015-10-28
Enrollment: 238
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, the investigators will test a new way to communicate advice on diet and lifestyle to women with gestational diabetes mellitus by app downloaded on women's smartphone. The app wishes to motivate women to have a healthy diet, and be physically active. It allows automatic transfer of blood glucose measures from the glucose meter to the smartphone. The women will answer questionnaires during pregnancy and be followed up three months postpartum.

Detailed description: Gestational diabetes mellitus (GDM), diabetes occuring for the first time during pregnancy, is an increasing problem worldwide. It may affect both the woman's and their offspring's health. Women with GDM have an increased risk of developing type 2 diabetes later in life. Pregnancy, offers a window of opportunity to instigate lasting changes beneficial for them and their families. Considering new technology available and used by women generally, new methods to communicate lifestyle and dietary advice are required.

The present study, a multi-center, randomised controlled trial includes five outpatients clinics in the greater Oslo Region and will include 230 pregnant women with gestational diabets mellitus. Data will be collected by three questionnaires during the study period, one at entry, before 33+0 weeks of gestation, one at 36 weeks and the last questionnaire at around three months postpartum. During pregnancy, the questionniares will be answered using an iPad while the last questionnaire will be on a website or through an interview.

Additional information will be collected from the women's medical record.

The intervention in this study is an app, called the Pregnant+ app (Gravid+) for smartphone. The app aims to reach women who are fluent in either Norwegian, Urdu or Somali. It has been translated from Norwegian and culturally adapted to women speaking Urdu or Somali. Women participating in the study can choose between different food cultures and they can set their personal lifestyle goals. Information about gestational diabetes, psysical activity, diet and food recipes are provided in the app. Half of the women in this study, will be given the app, downloaded on their smartphone.The opportunity to automatically transfer bloodglucose measures to the smartphone, presented in either a list or a graph, gives women an overview and therefore easier controll over their glucose levels.

The intervention will take place in the ordinary consultation at the outpatient clinics and no extra consultation are needed.

The data will be analysed according to intention to treat methods and with a parcicipatin rate on 75% it will take approximately 20 months to recruite 230 pregnant women. To detect a differences of 10% between the intervention group and the control group, 115 women are required in each group.

The Regional Committees for Medical and Health Research Ethics South East, (REK) reviewed the investigators' application and deemed ethical approval not required as the investigators' study does not test new medication or treatment, nor seeks to find new information about GDM but only tests a new way of communicating known and approved lifestyle advice to women with GDM.

For each hospital the investigators received approval from the appropriate Board for patient privacy protection (PVO: Personvernombud). The study was approved at each hospital by the responsible medical officer.

The investigators' study has been approved by the Norwegian Social Science Data Services.

The RCT will be published in an international peer-reviewed scientific journal.

Eligibility criteria: Inclusion Criteria:

* First visit with gestational diabetes in this pregnancy
* Has her own smartphone
* Pregnancy up to 32 weeks and 6 days of gestation
* Fluent in Norwegian, Urdu or Somali
* Aged 18 years old and older

Exclusion Criteria:

* Pregnant with more than one fetus
* Lactose or gluten intolerance
* Known type 1 diabetes (insulin dependent)
* Known type 2 diabetes

Primary outcomes:
measure: Oral glucose tolerance test (OGTT), fasting and 2 hours blood glucose level after intake up til 75gr glucose (1.75gr/kg body weight)
timeFrame: Approximately three months after delivery.
Secondary outcomes:
measure: complications of pregnancy
timeFrame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum
measure: Dietary intake measured by "Fit for fødsel Food questionnaire"
timeFrame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum
measure: Knowledge of gestational diabetes
timeFrame: Data will be collected prior to 33 weeks gestation, and at 36 weeks gestation
measure: Physical activity
timeFrame: Data wil be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum
measure: Depression
timeFrame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum
measure: Motivation for physical activity
timeFrame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum
measure: Motivation for eating healthy
timeFrame: Data will be collected prior to 33 weeks gestation, at 36 weeks, up to 4 months postpartum
measure: Mode of delivery and complications at birth for the mother
timeFrame: at birth
measure: Complications for the newborn
timeFrame: at birth
measure: Condition of the newborn
timeFrame: at birth and approx three months postpartum
measure: Starting medication for controlling blood glucose levels for the pregnant woman
timeFrame: during pregnancy
measure: Blood glucose control during pregnancy
timeFrame: during pregnancy
measure: HbA1c
timeFrame: Approx three months postpartum
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital
Study officials:
affiliation: Oslo Metropolitan University
name: Mirjam Lukasse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garnweidner-Holme LM, Borgen I, Garitano I, Noll J, Lukasse M. Designing and Developing a Mobile Smartphone Application for Women with Gestational Diabetes Mellitus Followed-Up at Diabetes Outpatient Clinics in Norway. Healthcare (Basel). 2015 May 21;3(2):310-23. doi: 10.3390/healthcare3020310.
citation: Garnweidner-Holme L, Henriksen L, Bjerkan K, Lium J, Lukasse M. Factors associated with the level of physical activity in a multi-ethnic pregnant population - a cross-sectional study at the time of diagnosis with gestational diabetes. BMC Pregnancy Childbirth. 2022 Jan 3;22(1):1. doi: 10.1186/s12884-021-04335-x.
citation: Garnweidner-Holme L, Henriksen L, Torheim LE, Lukasse M. Effect of the Pregnant+ Smartphone App on the Dietary Behavior of Women With Gestational Diabetes Mellitus: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Nov 4;8(11):e18614. doi: 10.2196/18614.
citation: Borgen I, Smastuen MC, Jacobsen AF, Garnweidner-Holme LM, Fayyad S, Noll J, Lukasse M. Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway. BMJ Open. 2019 Nov 11;9(11):e030884. doi: 10.1136/bmjopen-2019-030884.
citation: Borgen I, Garnweidner-Holme LM, Jacobsen AF, Bjerkan K, Fayyad S, Joranger P, Lilleengen AM, Mosdol A, Noll J, Smastuen MC, Terragni L, Torheim LE, Lukasse M. Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial. BMJ Open. 2017 Mar 27;7(3):e013117. doi: 10.1136/bmjopen-2016-013117.