A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With Gestational Diabetes Mellitus - RCT

Brief Summary

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.

Primary Outcomes

Secondary Outcomes

• complications of pregnancy(Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum)
• Depression(Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum)
• Knowledge of gestational diabetes(Data will be collected prior to 33 weeks gestation, and at 36 weeks gestation)
• Physical activity(Data wil be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum)
• Motivation for physical activity(Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum)
• Dietary intake measured by "Fit for fødsel Food questionnaire"(Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum)
• Complications for the newborn(at birth)
• Starting medication for controlling blood glucose levels for the pregnant woman(during pregnancy)
• Motivation for eating healthy(Data will be collected prior to 33 weeks gestation, at 36 weeks, up to 4 months postpartum)
• Mode of delivery and complications at birth for the mother(at birth)
• Condition of the newborn(at birth and approx three months postpartum)
• Blood glucose control during pregnancy(during pregnancy)
• HbA1c(Approx three months postpartum)