跳至主要内容
临床试验/NCT03073551
NCT03073551Unknown不适用

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

Unity Health Toronto0 个研究点目标入组 150 人开始时间: 2010年7月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
Glucose levels

研究概览

简要总结

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.

详细描述

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:

  1. Control - routine GDM care as mentioned above.
  2. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

Glucose levels

时间窗: Measured from study intake date until 36 weeks gestation

Mean fasting and post-prandial glucose levels

次要结局

  • Insulin therapy(Measured from study intake date until 36 weeks gestation)
  • Activity level(Measured from study intake date until 36 weeks gestation)
  • Maternal weight gain(Weight gained during pregnancy, measured from start of pregnancy (1 week gestation) to end of pregnancy (up to 40 weeks gestation).)

研究者

申办方类型
Other
责任方
Sponsor

相似试验