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The Impact of Activity Promoting Video Games on Glycemic Control in Gestational Diabetes Mellitus

Primary Purpose

Gestational Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wii Group
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gestational Diabetes Mellitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women diagnosed with gestational diabetes and a singleton pregnancy at 24-36 weeks of gestation.

Exclusion Criteria:

  • 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Control Group

    Wii Group

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Glucose levels
    Mean fasting and post-prandial glucose levels

    Secondary Outcome Measures

    Insulin therapy
    Need for insulin therapy to control insulin levels
    Activity level
    Level of daily physical activity performed
    Maternal weight gain
    Measured as the amount of weight gained from time of conception to time of delivery

    Full Information

    First Posted
    February 3, 2017
    Last Updated
    April 28, 2020
    Sponsor
    Unity Health Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03073551
    Brief Title
    The Impact of Activity Promoting Video Games on Glycemic Control in Gestational Diabetes Mellitus
    Official Title
    The Impact of Activity Promoting Video Games on Glycemic Control in Gestational Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 27, 2010 (Actual)
    Primary Completion Date
    August 1, 2022 (Anticipated)
    Study Completion Date
    August 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Unity Health Toronto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    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
    Arm Title
    Wii Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Wii Group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Glucose levels
    Description
    Mean fasting and post-prandial glucose levels
    Time Frame
    Measured from study intake date until 36 weeks gestation
    Secondary Outcome Measure Information:
    Title
    Insulin therapy
    Description
    Need for insulin therapy to control insulin levels
    Time Frame
    Measured from study intake date until 36 weeks gestation
    Title
    Activity level
    Description
    Level of daily physical activity performed
    Time Frame
    Measured from study intake date until 36 weeks gestation
    Title
    Maternal weight gain
    Description
    Measured as the amount of weight gained from time of conception to time of delivery
    Time Frame
    Weight gained during pregnancy, measured from start of pregnancy (1 week gestation) to end of pregnancy (up to 40 weeks gestation).

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Participants must be pregnant women
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women diagnosed with gestational diabetes and a singleton pregnancy at 24-36 weeks of gestation. Exclusion Criteria: 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Howard Berger, MD
    Organizational Affiliation
    Unity Health Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Impact of Activity Promoting Video Games on Glycemic Control in Gestational Diabetes Mellitus

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