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

NCT03073551 | Unknown

• 1 other identifier: 10-188
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gestational Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Glucose levels

  Mean fasting and post-prandial glucose levels

  Measured from study intake date until 36 weeks gestation

Secondary Outcomes (3)

• 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).

Study Arms (2)

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.

Other: Wii Group

Interventions

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.

Wii Group

Eligibility Criteria

• Gender Eligibility Details: Participants must be pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Unity Health Toronto: lead

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Howard Berger, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: March 8, 2017
• Study Start: July 27, 2010
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share