Gestational Diabetes Mellitus Clinical Trial
Official title:
A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With Gestational Diabetes Mellitus - RCT
Verified date | April 2018 |
Source | Oslo and Akershus University College of Applied Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 238 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo university hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo and Akershus University College of Applied Sciences | Oslo University Hospital, The Norwegian Centre for Minority Health Research, Universitetssenteret på Kjeller, University Hospital, Akershus, Vestre Viken Hospital Trust |
Norway,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | HbA1c | Measured at home by visiting researcher, finger prick blood. | Approx three months postpartum |
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