ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02588729
Recruitment Status : Completed
First Posted : October 28, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborators:
Universitetssenteret på Kjeller
Oslo University Hospital
Vestre Viken Hospital Trust
University Hospital, Akershus
The Norwegian Centre for Minority Health Research
Information provided by (Responsible Party):
Mirjam Lukasse, Oslo and Akershus University College of Applied Sciences

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Other: Pregnant+ app for smartphone Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With Gestational Diabetes Mellitus - RCT
Actual Study Start Date : October 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pregnant+ app for smartphone (Gravid+)
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
The Pregnant+app for smartphone with information about a healthy diet, physical activity and management of gestational diabetes mellitus.

No Intervention: No admission to Pregnant+ app (Gravid+)
The control group will receive standard care at the outpatient departments. Participants to not receive the Pregnancy



Primary Outcome Measures :
  1. Oral glucose tolerance test (OGTT), fasting and 2 hours blood glucose level after intake up til 75gr glucose (1.75gr/kg body weight) [ Time Frame: Approximately three months after delivery. ]
    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


Secondary Outcome Measures :
  1. complications of pregnancy [ Time Frame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum ]
    Raised BP, vaginal bleeding, amniotic fluid leakage, preeclampsia, nausea and vomitting, Braxton Hicks Contractions, UTI, Candida vaginal infection, pelvic girdle pain

  2. Dietary intake measured by "Fit for fødsel Food questionnaire" [ Time Frame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum ]
    Fit for fødsel Food questionnaire, 41 questions. Number of participants following ten items of advice on low glucose, high fiber diet.

  3. Knowledge of gestational diabetes [ Time Frame: Data will be collected prior to 33 weeks gestation, and at 36 weeks gestation ]
    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.

  4. Physical activity [ Time Frame: Data wil be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum ]

    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.


  5. Depression [ Time Frame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum ]
    Edinburgh Depression Scale- short version, 5 questions. Number of participants with depression. Cut-off at either total score of 7 or 8.

  6. Motivation for physical activity [ Time Frame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum ]
    4 questions assessing women's motivation to be physically active, number of women with high score and increasing score.

  7. Motivation for eating healthy [ Time Frame: Data will be collected prior to 33 weeks gestation, at 36 weeks, up to 4 months postpartum ]
    3 questions assessing women's motivation to eat healthy, number of women with high score and increasing score.

  8. Mode of delivery and complications at birth for the mother [ Time Frame: at birth ]
    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.

  9. Complications for the newborn [ Time Frame: at birth ]
    Number of newborns who were transferred to intensive care unit, who were diagnosed with hypoglycaemia, information from the Medical records.

  10. Condition of the newborn [ Time Frame: at birth and approx three months postpartum ]
    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.

  11. Starting medication for controlling blood glucose levels for the pregnant woman [ Time Frame: during pregnancy ]
    Number of patients who start to use insulin or Metformin during pregnancy, information from the patient notes

  12. Blood glucose control during pregnancy [ Time Frame: 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

  13. HbA1c [ Time Frame: Approx three months postpartum ]
    Measured at home by visiting researcher, finger prick blood.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588729


Locations
Norway
Oslo university hospital
Oslo, Norway, 4950
Sponsors and Collaborators
Oslo and Akershus University College of Applied Sciences
Universitetssenteret på Kjeller
Oslo University Hospital
Vestre Viken Hospital Trust
University Hospital, Akershus
The Norwegian Centre for Minority Health Research
Investigators
Principal Investigator: Mirjam Lukasse, PhD Oslo and Akershus University College of Applied Sciences

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mirjam Lukasse, Associate professor, Oslo and Akershus University College of Applied Sciences
ClinicalTrials.gov Identifier: NCT02588729     History of Changes
Other Study ID Numbers: 38942
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Keywords provided by Mirjam Lukasse, Oslo and Akershus University College of Applied Sciences:
Gestational diabetes
app
RCT
diet
physical activity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications