Mobile Exergaming in Type 2 Diabetes

NCT ID: NCT02657018

Last Updated: 2018-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-04-30

Brief 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.

Detailed 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.

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

MOBIGAME group

Group Type: EXPERIMENTAL

MOBIGAME

Intervention Type: DEVICE

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.

Control

Lifestyle counseling group

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University of Basel

OTHER

Sponsor Role: lead

Responsible Party

Arno Schmidt-Trucksäss

Prof. Arno Schmidt-Trucksäss MD, MA, FESC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arno Schmidt-Trucksäss, MD, MA, FESC

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Locations

Division of Sports and Exercise Medicine, Department of Sport, Exercise and Health, University of Basel

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

References

Hochsmann C, Muller O, Ambuhl M, Klenk C, Konigstein K, Infanger D, Walz SP, Schmidt-Trucksass A. Novel Smartphone Game Improves Physical Activity Behavior in Type 2 Diabetes. Am J Prev Med. 2019 Jul;57(1):41-50. doi: 10.1016/j.amepre.2019.02.017. Epub 2019 May 22.

Reference Type: DERIVED

PMID: 31128953 (View on PubMed)

Hochsmann C, Infanger D, Klenk C, Konigstein K, Walz SP, Schmidt-Trucksass A. Effectiveness of a Behavior Change Technique-Based Smartphone Game to Improve Intrinsic Motivation and Physical Activity Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial. JMIR Serious Games. 2019 Feb 13;7(1):e11444. doi: 10.2196/11444.

Reference Type: DERIVED

PMID: 30758293 (View on PubMed)

Hochsmann C, Walz SP, Schafer J, Holopainen J, Hanssen H, Schmidt-Trucksass A. Mobile Exergaming for Health-Effects of a serious game application for smartphones on physical activity and exercise adherence in type 2 diabetes mellitus-study protocol for a randomized controlled trial. Trials. 2017 Mar 6;18(1):103. doi: 10.1186/s13063-017-1853-3.

Reference Type: DERIVED

PMID: 28264717 (View on PubMed)

Other Identifiers

EKNZ 2015-424

Identifier Type: -

Identifier Source: org_study_id