Mobile Exergaming in Type 2 Diabetes

NCT02657018 | Completed

• 1 other identifier: EKNZ 2015-424
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change from baseline daily physical activity at 24 weeks

  Measured as steps per day.

  Baseline and 24 weeks

Secondary Outcomes (1)

• Adherence to the intervention

  24 weeks

Other Outcomes (14)

• Change from baseline self-determination at 24 weeks

  Baseline and 24 weeks

• Change from baseline cardiorespiratory fitness at 24 weeks

  Baseline and 24 weeks

• Change from baseline six minute walking distance at 24 weeks

  Baseline and 24 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

MOBIGAME group

Device: MOBIGAME

Control

ACTIVE COMPARATOR

Lifestyle counseling group

Other: Control

Interventions

MOBIGAME 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.

Intervention

Control 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.

Control

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Basel: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

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

Basel, Canton of Basel-City, 4052, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 31128953 DERIVED

• 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.

  PMID: 30758293 DERIVED

• 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.

  PMID: 28264717 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Arno Schmidt-Trucksäss, MD, MA, FESC

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Arno Schmidt-Trucksäss MD, MA, FESC

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 15, 2016
• Study Start: August 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)