Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO) (NCT04887077) | Clinical Trial Compass
CompletedNot Applicable
Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO)
France56 participantsStarted 2021-06-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject affected for obesity (BMI ≥30 kg/m² and \<45 kg/m²) and/or T2DM.
* Subject treated at the University Hospital of Clermont-Ferrand.
* The participants must have an iOS (at least iOS8 version) or Android (at least version 5) smartphone.
* Subjects must also be able to provide informed consent to participate in the research and be covered by health social security.
* Subjects must be native to any physical activity intervention.
* Sufficient proficiency of French will be required to ensure the understanding of the questionnaires.
Exclusion Criteria:
* Medical or surgical history judged by the investigator to be incompatible with the study.
* Subject with an unstable psychiatric condition.
* Pregnant or breastfeeding women.
* Heavy alcohol consumption (\> 2 to 3 drinks per day depending on gender) or drug addiction.
* Disability or contraindication to PA.
* Subject with cardiorespiratory and/or osteoarticular disorders that limit their ability to perform physical tests or moderate PA for 30 minutes.
* Subject with progressive cardiovascular or neoplastic disease.
* Subject who has presented a major infection in the 3 months prior to inclusion.
* Subject with a known neuro-muscular pathology (i.e., myopathy, myasthenia, rhabdomyolysis, paraplegia, hemiplegia).
* Subject with chronic or acute inflammatory pathology within 3 months prior to inclusion.
* Subject diagnosed and/or treated for schizophrenia, bipolar disorder, major depression.
* Subject …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in daily physical activity from baseline to 3 months