Mobile Exergaming in Type 2 Diabetes

Obesity Clinical Trial

— MOBIGAME  

Official title:

Mobile Exergaming for Health - Effects of a Serious Game Application for Smartphones on Physical Activity and Exercise Adherence in Type 2 Diabetes Mellitus (Randomized Controlled Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657018
• Other study ID #: EKNZ 2015-424
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: April 26, 2018
• Start date: August 2016
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate if MOBIGAME (an innovative, mobile phone-based game application) is suitable to increase daily physical activity and physical activity adherence as well as health parameters such as cardiorespiratory fitness, leg strength, glucose metabolism, vascular health and self-determination as well as health related quality of life in the course of a 24-week intervention in comparison to the control group receiving one-time lifestyle counseling.

Description:

In recent years, type 2 diabetes mellitus (T2DM) has grown into an emerging pandemic that is a key determinant of morbidity and mortality in both developed and developing countries worldwide. The successful treatment and prevention of T2DM is one of the biggest future health care challenges and most important to manage the enormous socio-economic burden that is associated with T2DM and its various comorbidities. Physical inactivity is known to be one of the most important risk factors for the development of obesity and T2DM. In contrast, increases in physical activity (PA) and fitness can lower the T2DM incidence, improve the patient's glucose metabolism and reduce morbidity and (premature) mortality, independent of body mass index (BMI) or other risk factors. Despite the obvious benefits of regular PA in the treatment and prevention of T2DM, most activity-promoting programs targeting T2DM patients are seldom successful in the long term due to diminishing patient motivation. A novel approach to motivate those individuals that are the least likely to engage in regular PA to be more physically active and adhere to regular PA are active video games or "exergames" that combine PA and video gaming. However, existing exergames do not offer fitness-level adjusted, individualized workouts and are normally stationary and bound to a TV, thus not enabling PA anywhere and at any time. To address these shortcomings, the investigators used sports scientific expertise to develop a smartphone-based, mobile gardening simulation game application, specifically designed for middle-aged T2DM patients, to induce a healthier, more active lifestyle as part of a successful T2DM treatment and management.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

• Informed Consent as documented by signature

• Non-insulin-dependent diabetes mellitus (doctor diagnosed)

• Body Mass Index >25 kg/m2

• Regular smartphone use during the last year before the study

• Motivation to participate in the study for its entire duration of 24 weeks

Exclusion Criteria:

• Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

• Previous enrolment into the current study

• Participation in other studies in the last four weeks

• Systolic blood pressure > 170mmHg, diastolic blood pressure > 100 mmHg

• Regular physical activity before the study (=150 min moderate intensity daily PA per week or >1 endurance or strength training session per week of more than 30 min in duration)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight

Intervention

Device:
• MOBIGAME
Mobile phone based game-like software application and platform (MOBIGAME) that includes individualized and structured exercise regimens (endurance, strength, balance and flexibility) that are based on the user's individual fitness evaluation (through established fitness tests) and incorporated into the story line of a gardening simulation game.

Other:
• Control
One-time standard lifestyle counseling including the promotion of baseline activities of daily life as well as a structured exercise plan including strength and endurance exercises with moderately increasing intensity and duration that is to be implemented autonomously.

Locations

Country	Name	City	State
Switzerland	Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
University of Basel	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline self-determination at 24 weeks	Self-determination (intrinsic motivation, perceived competence, perceived choice, perceived usefulness measured via the score in an abridged, 12-item version of the Intrinsic Motivation Inventory.	Baseline and 24 weeks
Other	Change from baseline cardiorespiratory fitness at 24 weeks	Aerobic capacity measured as VO2peak.	Baseline and 24 weeks
Other	Change from baseline six minute walking distance at 24 weeks	Measured via the Six Minute Walk Test	Baseline and 24 weeks
Other	Change from baseline isometric leg strength at 24 weeks	Measured as maximal isometric force and rate of force development.	Baseline and 24 weeks
Other	Change from baseline leg strength endurance at 24 weeks	Assessed as maximum number of repetitions in the Sit-to-Stand Test (STS)	Baseline and 24 weeks
Other	Change from baseline glucose metabolism at 24 weeks	Fasting glucose, glycated hemoglobin (HbA1c), fasting C-peptides, fasting insulin levels and insulin resistance, measured as homeostasis model assessment (HOMA) index.	Baseline and 24 weeks
Other	Change from baseline inflammatory markers at 24 weeks	Total cholesterol, LDL- and HDL-cholesterol, triglycerides, apolipoprotein B, irisin, adiponectin and interleukin-6	Baseline and 24 weeks
Other	Change from baseline central blood pressure at 24 weeks		Baseline and 24 weeks
Other	Change from baseline pulse wave reflection at 24 weeks	Measured as augmentation index.	Baseline and 24 weeks
Other	Change from baseline arterial stiffness at 24 weeks	Measured as aortic pulse wave velocity.	Baseline and 24 weeks
Other	Change from baseline microvascular function at 24 weeks	Measured as retinal vessel diameters.	Baseline and 24 weeks
Other	Change from baseline health-related quality of life (HRQOL) at 24 weeks	Assessed with score in the 36-item Short Form questionnaire (SF-36).	Baseline and 24 weeks
Other	Change from baseline fatigue at 24 weeks	Measured via the score in the 13-item FACIT Fatigue Scale.	Baseline and 24 weeks
Other	Perceived acceptance of intervention	Measured via the Technology Acceptance Model (TAM) questionnaire.	24 weeks
Primary	Change from baseline daily physical activity at 24 weeks	Measured as steps per day.	Baseline and 24 weeks
Secondary	Adherence to the intervention	Measured as usage log entries (intervention group) and self-reported exercise log entries (control group).	24 weeks