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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Other: Pregnant+ app for smartphone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant+ app for smartphone (Gravid+)<br>The intervention consists of the Pregnant+app downloaded on women's smartphone. The app contains culturally adapted information about physical activity, diet and management of GDM. The Gravid+app will be available in Norwegain, Urdu and Somali. Women will have the opportunity to automatically transfer their blood glucose levels to their smartphones via Bluetooth. | Other: Pregnant+ app for smartphone<br>* The Pregnant+app for smartphone with information about a healthy diet, physical activity and management of gestational diabetes mellitus.<br>|
| No Intervention: No admission to Pregnant+ app (Gravid+)<br>The control group will receive standard care at the outpatient departments. Participants to not receive the Pregnancy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral glucose tolerance test (OGTT), fasting and 2 hours blood glucose level after intake up til 75gr glucose (1.75gr/kg body weight) | Part of routine care for women who had GDM, is an OGTT about three months postpartum, taken at their laboratory and reported to the investigators.Number of participants with level below 7.5 mmol | Approximately three months after delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of pregnancy | Raised BP, vaginal bleeding, amniotic fluid leakage, preeclampsia, nausea and vomitting, Braxton Hicks Contractions, UTI, Candida vaginal infection, pelvic girdle pain | Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum | 
| Dietary intake measured by Fit for fødsel Food questionnaire | Fit for fødsel Food questionnaire, 41 questions. Number of participants following ten items of advice on low glucose, high fiber diet. | Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum | 
| Knowledge of gestational diabetes | 7 questions assessing knowledge of gestational diabetes and understanding of glucose measurements and control of those. Number of participants with high understanding of GDM at 36 weeks, and number of participants with increasing knowledge. | Data will be collected prior to 33 weeks gestation, and at 36 weeks gestation | 
| Physical activity | PPAQ:Pregnancy Physical Activity Questionnaire (37 questions). Comparison of participants in both arms of the study for Level of physical activity. Number of participants with low, moderate or high level of activity. | Data wil be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum | 
| Depression | Edinburgh Depression Scale- short version, 5 questions. Number of participants with depression. Cut-off at either total score of 7 or 8. | Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum | 
| Motivation for physical activity | 4 questions assessing women's motivation to be physically active, number of women with high score and increasing score. | Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum | 
| Motivation for eating healthy | 3 questions assessing women's motivation to eat healthy, number of women with high score and increasing score. | 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 | From the Medical records, number of women for each group: induction, mode of delivery, shoulderdystocia, postpartum haemorrhage, Sphincter rupture, episiotomi, manual removal of placenta, Hb below 11 gr/dl, infection, removal of retained products. | at birth | 
| Complications for the newborn | Number of newborns who were transferred to intensive care unit, who were diagnosed with hypoglycaemia, information from the Medical records. | at birth | 
| Condition of the newborn | Number of newborns with Apgar score below 7 at 5 minutes, birth weight above different cut-offs (3.5 kg and 4kg), full breastfeeding and other nutrition from pasient notes and 3 months postpartum questionnaire. | at birth and approx three months postpartum | 
| Starting medication for controlling blood glucose levels for the pregnant woman | Number of patients who start to use insulin or Metformin during pregnancy, information from the patient notes | during pregnancy | 
| Blood glucose control during pregnancy | Number of patients with, fasting glucose over 5.5 gr/dl, HbA1c above 7.0% at 30,32,34,36,38 and 40 weeks | during pregnancy | 
| HbA1c | Measured at home by visiting researcher, finger prick blood. | Approx three months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gestational diabetes, app, RCT, diet, physical activity