Gestational Diabetes MellitusNCT02588729
A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With GDM - RCT
A study testing Pregnant+ app for smartphone in people with Gestational Diabetes Mellitus, run by Oslo Metropolitan University at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Pregnant+ app for smartphone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant with more than one fetus
- Lactose or gluten intolerance
- Known type 1 diabetes (insulin dependent)
- Known type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With Gestational Diabetes Mellitus - RCT
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.
Read the 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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Pregnant+ app for smartphone
- Keywords
- Gestational diabetes, app, RCT, diet, physical activity
- Medical subject headings
- Diabetes, Gestational, Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant+ app for smartphoneOther
The Pregnant+app for smartphone with information about a healthy diet, physical activity and management of gestational diabetes mellitus.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant+ app for smartphone (Gravid+) | Experimental | 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. Receives: Other: Pregnant+ app for smartphone |
| No admission to Pregnant+ app (Gravid+) | No intervention | The control group will receive standard care at the outpatient departments. Participants to not receive the Pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately three months after delivery.
Secondary outcomes (13)
complications of pregnancy
Raised BP, vaginal bleeding, amniotic fluid leakage, preeclampsia, nausea and vomitting, Braxton Hicks Contractions, UTI, Candida vaginal infection, pelvic girdle pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: during pregnancy
HbA1c
Measured at home by visiting researcher, finger prick blood.
Measured: Approx three months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitetssenteret på Kjeller, Oslo University Hospital, Vestre Viken Hospital Trust, University Hospital, Akershus, The Norwegian Centre for Minority Health Research
- Responsible party
- Principal investigator, Mirjam Lukasse, Oslo Metropolitan University
- Investigators
- Mirjam Lukasse, PhD, Principal investigator, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588729
- Sponsor's protocol ID
- 38942
- Status last verified
- Apr 2018
- First submitted
- 31 Aug 2015
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27417764Garnweidner-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.
PubMed 34979996Garnweidner-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.
PubMed 33146620Borgen 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.
PubMed 31719080Borgen 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.
PubMed 28348183
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With Gestational Diabetes Mellitus - RCT
- ClinicalTrials.gov ID
- NCT02588729
- Acronym / sponsor ID
- 38942
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- Gestational diabetes, app, RCT, diet, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Universitetssenteret på Kjeller, Oslo University Hospital, Vestre Viken Hospital Trust, University Hospital, Akershus, The Norwegian Centre for Minority Health Research
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant+ app for smartphone (Gravid+) | Experimental | Other: Pregnant+ app for smartphoneThe 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. |
| No admission to Pregnant+ app (Gravid+) | No intervention | –The control group will receive standard care at the outpatient departments. Participants to not receive the Pregnancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant with more than one fetus
- Lactose or gluten intolerance
- Known type 1 diabetes (insulin dependent)
- Known type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnant+ app for smartphoneThe Pregnant+app for smartphone with information about a healthy diet, physical activity and management of gestational diabetes mellitus. | Other | Pregnant+ app for smartphone (Gravid+) |
Primary outcome
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
13 secondary outcomes
complications of pregnancy
Time frame: 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"
Time frame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation and up to 4 months postpartum
Knowledge of gestational diabetes
Time frame: Data will be collected prior to 33 weeks gestation, and at 36 weeks gestation
Physical activity
Time frame: Data wil be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum
Depression
Time frame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum
Motivation for physical activity
Time frame: Data will be collected prior to 33 weeks gestation, at 36 weeks gestation, up to 4 months postpartum
Motivation for eating healthy
Time frame: 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
Time frame: at birth
Complications for the newborn
Time frame: at birth
Condition of the newborn
Time frame: at birth and approx three months postpartum
Starting medication for controlling blood glucose levels for the pregnant woman
Time frame: during pregnancy
Blood glucose control during pregnancy
Time frame: during pregnancy
HbA1c
Time frame: Approx three months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 27417764Garnweidner-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.
- Derived from this study: PubMed 34979996Garnweidner-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.
- Derived from this study: PubMed 33146620Garnweidner-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.
- Derived from this study: PubMed 31719080Borgen 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.
- Derived from this study: PubMed 28348183Borgen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Lukasse, PhD principal investigator
Oslo Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pregnant+ app for smartphone in people with Gestational Diabetes Mellitus, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02588729, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.