Gestational Diabetes MellitusNCT03073551
The Impact of Activity Promoting Video Games on Glycemic Control in Gestational Diabetes Mellitus
A study testing Wii Group in people with Gestational Diabetes Mellitus, run by Unity Health Toronto.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Wii Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 27 Jul 2010to 1 Aug 2022
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women diagnosed with gestational diabetes and a singleton pregnancy at 24-36 weeks of gestation.
Who cannot join
- Multiple gestation
- Pre-gestational diabetes
- Unable to provide informed consent
- Any contraindication to performing physical activity in pregnancy (e.g. increased risk of preterm delivery)
- Has and regularly uses a Nintendo Wii console
- Presence of co-morbidities including: Hypertension (systolic pressure > 160 mmHg and/or diastolic pressure > 100 mmHg), alcohol abuse (i.e. 2 glasses alcohol or more per day); drug abuse, use of the medication that affects insulin secretion or insulin sensitivity (antiviral, corticosteroids, antihypertensive drugs, all concomitant medication will be discussed); serious pulmonary (COPD, exercise induced asthma), cardiac, hepatic or renal (serum creatinine > 150 μmol/l) impairment; malignant disease; serious mental or physical impairment (limiting the ability to understand or implement the study protocol).
About this study
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 Wii™ activity promoting gaming platform will increase activity levels, improve glycemic control of sugar levels and decrease the need for supplementary insulin treatment.
Read the detailed description
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:
- Control - routine GDM care as mentioned above.
- Intervention - This group will undergo all aspects of routine GDM care but will also receive a Nintendo Wii gaming console + Wii Fit activity platform. The games provided include "Wii sport" and Wii Fit Plus". Each participant will receive a 30-60 minute guided information session to ensure that she is able to install the console at home and to set up her personal login information. At this session an overview of the available Wii activities will be presented. Each participant will receive a telephone number to call in case technical difficulties are encountered at home. At 36 weeks of gestation, the Wii hardware and programs will be returned to the investigators. Participants will be instructed to note the following warning signs for termination of the exercise session; vaginal bleeding, dyspnea before exertion, dizziness, headache, chest pain, muscle weakness, calf pain or swelling, preterm labor, decreased fetal movement, and amniotic fluid leakage.
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.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Wii Group
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wii GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Wii Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose levels
Mean fasting and post-prandial glucose levels
Measured: Measured from study intake date until 36 weeks gestation
Secondary outcomes (3)
Insulin therapy
Need for insulin therapy to control insulin levels
Measured: Measured from study intake date until 36 weeks gestation
Activity level
Level of daily physical activity performed
Measured: 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
Measured: Weight gained during pregnancy, measured from start of pregnancy (1 week gestation) to end of pregnancy (up to 40 weeks gestation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start27 Jul 2010
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Berger, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073551
- Sponsor's protocol ID
- 10-188
- Status last verified
- Apr 2020
- First submitted
- 3 Feb 2017
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Activity Promoting Video Games on Glycemic Control in Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03073551
- Acronym / sponsor ID
- 10-188
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 27 Jul 2010 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 8 Mar 2017 (actual)
- 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.
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 Wii™ activity promoting gaming platform will increase activity levels, improve glycemic control of sugar levels and decrease the need for supplementary insulin treatment.
Detailed description
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:
- Control - routine GDM care as mentioned above.
- Intervention - This group will undergo all aspects of routine GDM care but will also receive a Nintendo Wii gaming console + Wii Fit activity platform. The games provided include "Wii sport" and Wii Fit Plus". Each participant will receive a 30-60 minute guided information session to ensure that she is able to install the console at home and to set up her personal login information. At this session an overview of the available Wii activities will be presented. Each participant will receive a telephone number to call in case technical difficulties are encountered at home. At 36 weeks of gestation, the Wii hardware and programs will be returned to the investigators. Participants will be instructed to note the following warning signs for termination of the exercise session; vaginal bleeding, dyspnea before exertion, dizziness, headache, chest pain, muscle weakness, calf pain or swelling, preterm labor, decreased fetal movement, and amniotic fluid leakage.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Wii GroupParticipants 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women diagnosed with gestational diabetes and a singleton pregnancy at 24-36 weeks of gestation.
Key exclusion criteria (6 listed)
- Multiple gestation
- Pre-gestational diabetes
- Unable to provide informed consent
- Any contraindication to performing physical activity in pregnancy (e.g. increased risk of preterm delivery)
- Has and regularly uses a Nintendo Wii console
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 |
|---|---|---|
| Wii GroupParticipants 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. | Other | Wii Group |
Primary outcome
Glucose levels
Time frame: Measured from study intake date until 36 weeks gestation
Mean fasting and post-prandial glucose levels
3 secondary outcomes
Insulin therapy
Time frame: Measured from study intake date until 36 weeks gestation
Activity level
Time frame: Measured from study intake date until 36 weeks gestation
Maternal weight gain
Time frame: Weight gained during pregnancy, measured from start of pregnancy (1 week gestation) to end of pregnancy (up to 40 weeks gestation).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Howard Berger, MD principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Wii Group in people with Gestational Diabetes Mellitus, run by Unity Health Toronto.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Glucose levels (time frame: Measured from study intake date until 36 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2020.