CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
NCT Number: NCT04887077
Overweight and obesity are today considered among the most important health risks facing humanity with more than one in two adults overweight or obese in western countries. In addition, Type 2 diabetes mellitus (T2DM) is a common comorbidity associated with overweight and obesity and counts for 5% of the French population under 65 years of age and 15% in people over 65 years old. Despite the accumulation of scientific evidence supporting the benefits of physical activity, obese and diabetic people remain insufficiently active and current programs struggle to engage and sustain physical activity of patients over long periods of time. It is therefore urgent to develop interventions that can effectively change individuals' behavior. In this context, "e-health" interventions and gamification appear to be a particularly promising avenue to improve physical activity and reduce attrition rates of current programs.
This clinical trial aim to test the effectiveness of a digital intervention based on gamification and teamwork in comparison to a supervised physical activity program. The investigators hypothesized that the intervention will be efficient by the development of a self-determined motivation through the process of gamification on the one hand. On the other hand, through the in-group collaboration with other people who share the same stigmatized criteria that will help participants to overcome weight stigmas, acting generally as physical activity barriers.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Clermont-Ferrand, 63000, France
This trial is a randomized, two-arm intervention design that will examine the efficacy of a digital group-based intervention based on gamification and teamwork among obese and T2DM patients. The experimental arm will be compared to an active control group representing the traditional care program (supervised physical activity).
The digital intervention is composed of four components within a smartphone application: a) a gamification of PA, b) a remote adapted physical activity program with telecoaching sessions, c) an interface for exchange and conversation and, d) an activity monitoring tool. Accelerometer data, self-reported PA, body composition, and physical capacities will be assessed before, at the end of the intervention and then at the issue of a 6-month follow up. To advance our understanding of complex interventions like gamified and group-based ones, this study will explore several psychological mediators relative to motivation, enjoyment, in-group identification, or perceived weight stigma. Finally, to assess a potential superior efficiency compared to the current treatment (face-to-face supervised PA), this study will include a cost-utility analysis between the two conditions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Kiplin intervention will be composed of four components within a smartphone application: a) a gamification of Physical Activity through multiple games called "animations", b) a remote adapted physical activity program with telecoaching sessions, c) an interface for exchange and conversation and, d) an activity monitoring tool.
three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions.
Time frame: Month 3
The primary outcome will be the change of daily physical activity measured as the daily step count assessed via the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)
Time frame: Month 9
in kg/m2
Time frame: Month 9
evaluated by bioelectrical impedance analysis
Time frame: Month 9
measured as the daily step count assessed via the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)
Time frame: Month 9
total physical activity (minutes/day) measured using the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)
Time frame: Month 9
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Time frame: Month 9
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Time frame: Month 9
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Time frame: Month 9
measured using the RPAQ
Time frame: Month 9
measured via the 6-minute walking test
Time frame: Month 9
measured via handgrip measurements
Time frame: Month 9
measured via isokinetic dynamometer
Time frame: Month 3
number of APA sessions attended. Application engagement and utilization for the experimental group only
Time frame: Month 9
measured via the EQ-5D
Time frame: Month 9
measured using incremental cost-effectiveness ratio between the average difference in cost and the average difference in effectiveness (QALY) observed between the two arms
Time frame: Month 3
measured using the Physical Activity Enjoyment Scale (PACES)
Time frame: Month 3
measured via the In-group identification questionnaire
Time frame: Month 3
measured via the Psychological Need Satisfaction in Exercise Scale (PNSES)
Time frame: Month 9
Autonomous and controlled motivation toward physical activity via the EMAPS.
Time frame: Month 9
measured using the scale developed by Hunger and Major
Time frame: Month 9
measured via the everyday discrimination scale
Time frame: Month 9
measured via the Modified Weight Bias Internalization Scale (WBIS-M)
Time frame: Month 9
measured using the perceived vulnerability questionnaire
Time frame: Month 9
measured using a single item
Time frame: Month 3
measured via the Borg scale
University Hospital, Clermont-Ferrand
Other
Digital Intervention Promoting Physical Activity Among Obese People Randomized Controlled Trial: Assessing the Effects of a Digital Intervention to Promote Physical Activity in Patients With Obesity and/or Type 2 Diabetes Mellitus
Acronym: DIPPAO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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