Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Gestational diabetes mellitus (GDM) affects up to 3-5% of all pregnancies. When diagnosed with GDM, women undergo nutritional counseling, blood sugars monitoring and are encouraged to exercise regularly. Women who do not meet therapeutic targets may need to add insulin injections. Activity promoting video games are an attractive possibility for improvement of exercise compliance. The objective of this study is to determine whether providing women recently diagnosed with GDM with a Nintendo Wiiâ„¢ activity promoting gaming platform will increase activity levels, improve glycemic control of sugar levels and decrease the need for supplementary insulin treatment.
As part of the standard of care, all pregnant women are screened with a 50 gram glucose challenge test between 24-28 weeks gestation. Women are diagnosed with GDM when they have two abnormal values on the 75 gram oral glucose tolerance test. Once a diagnosis of GDM has been made women are referred to the diabetes in pregnancy clinic within 1-2 weeks. All women initially undergo a group session with a clinical nutritionist and a registered nurse specializing in diabetic care. During this session women receive basic information regarding gestational diabetes, instruction regarding dietary management of GDM and standard recommendations regarding physical activity. Women also routinely receive a glucometer for self monitoring of glucose levels and are instructed regarding its use. One week after this group session an intake session with an endocrinologist and Maternal-Fetal Medicine specialist occurs and glycemic control is reviewed. Follow up visits are scheduled every 1-4 weeks depending on adequacy of glycemic control. Decisions regarding adequacy of dietary management and need for insulin therapy are made by the endocrinologist at each subsequent visit.
For the purpose of our study, patients will be approached after this group teaching session. Eligible patients who have consented to participate in the study will undergo randomization into two groups:
As mentioned, all participants in the study will be encouraged to be physically active. In order to independently calculate and compare the overall level of physical activity in both groups all participating women will receive a pedometer (StepsCount Digi-Walker SW700) and will be instructed to wear it daily during waking hours.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Participants in this group will receive diabetic care and education as per the standard of care. They will also be given a pedometer and will be instructed to record their number of steps at the end of each day | |
| Wii Group | Active Comparator | Participants in this group will receive diabetic care and education as per the standard of care. They will also be given a Wii console and game to take home. Participants will be instructed on how to set up and use the Wii. These participants will also be given a pedometer and will be instructed to record their number of steps at the end of each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wii Group | Other | Participants in the Wii group will be given a Wii console and video game to take home. The console includes a Wii balance board and remote controller. The Wii Fit game allows participants to choose different types of exercise such as yoga, aerobics, balance training, and more. Participant movements are shown on screen as they move with the balance board and remote control. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose levels | Mean fasting and post-prandial glucose levels | Measured from study intake date until 36 weeks gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin therapy | Need for insulin therapy to control insulin levels | Measured from study intake date until 36 weeks gestation |
| Activity level | Level of daily physical activity performed |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants must be pregnant women
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Howard Berger, MD | Unity Health Toronto | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
Not provided
Not provided
The control group will receive diabetes treatment and education as per standard of care.
The intervention group will receive diabetes treatment and education as per standard of care, and will also be given a Wii game console to bring home.
Not provided
Not provided
Not provided
Not provided
|
| Measured from study intake date until 36 weeks gestation |
| Maternal weight gain | Measured as the amount of weight gained from time of conception to time of delivery | Weight gained during pregnancy, measured from start of pregnancy (1 week gestation) to end of pregnancy (up to 40 weeks gestation). |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |