ObesityDIPPAONCT04887077
Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO)
A study testing Kiplin and face-to-face in people with Obesity and Diabete Type 2, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Diabete Type 2
- What is being tested?
- Kiplin and face-to-face
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2021to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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 deprived of their liberty by judicial or administrative decision.
- Subject refusing to sign the written consent to participate.
- Subject participating in another study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Obesity, Diabete Type 2
- Being tested
- Kiplin, face-to-face
- Keywords
- eHealth, Physical activity, Gamification, Mobile app, Behavior change, Cost-utility, Weight stigma
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Motor Activity, Weight Prejudice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KiplinDevice
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.
face-to-faceBehavioural
three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Kiplin intervention | Experimental | Kiplin intervention composed of the access to a mobile app and to telecoaching sessions. The number of teleocaching sessions per week will decrease over 3 months. Receives: Device: Kiplin |
| face-to-face supervised PA (usual care at the University Hospital of Clermont-Ferrand, France) | Active comparator | three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions. Receives: Behavioral: face-to-face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily physical activity from baseline to 3 months
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)
Measured: Month 3
Secondary outcomes (21)
Change in body composition (BMI) from baseline to 9 months
in kg/m2
Measured: Month 9
Change in body composition from baseline to 9 months
evaluated by bioelectrical impedance analysis
Measured: Month 9
Change in daily physical activity from baseline to 9 months
measured as the daily step count assessed via the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)
Measured: Month 9
Change in physical activity level from baseline to 9 months
total physical activity (minutes/day) measured using the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)
Measured: Month 9
Change in moderate-to-vigorous physical activity (MVPA) from baseline to 9 months
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Measured: Month 9
Change in light physical activity (LPA) from baseline to 9 months
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Measured: Month 9
Change in sedentary time from baseline to 9 months
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Measured: Month 9
Change in self-reported physical activity from baseline to 9 months
measured using the RPAQ
Measured: Month 9
Change in six minute walking distance from baseline to 9 months
measured via the 6-minute walking test
Measured: Month 9
Change in muscular strength of the upper limbs from baseline to 9 months
measured via handgrip measurements
Measured: Month 9
Change in muscular strength of the lower limbs from baseline to 9 months
measured via isokinetic dynamometer
Measured: Month 9
Programme adherence
number of APA sessions attended. Application engagement and utilization for the experimental group only
Measured: Month 3
Change in quality of life from baseline to 9 months
measured via the EQ-5D
Measured: Month 9
Cost-utility analysis
measured using incremental cost-effectiveness ratio between the average difference in cost and the average difference in effectiveness (QALY) observed between the two arms
Measured: Month 9
Perceived enjoyment of physical activity at the end of the intervention
measured using the Physical Activity Enjoyment Scale (PACES)
Measured: Month 3
Social identification at the end of the intervention
measured via the In-group identification questionnaire
Measured: Month 3
Psychological needs satisfaction at the end of the intervention
measured via the Psychological Need Satisfaction in Exercise Scale (PNSES)
Measured: Month 3
Change in motivation toward physical activity from baseline to 9 months
Autonomous and controlled motivation toward physical activity via the EMAPS.
Measured: Month 9
Change in weight stigma concerns from baseline to 9 months
measured using the scale developed by Hunger and Major
Measured: Month 9
Change in perceived daily discrimination from baseline to 9 months
measured via the everyday discrimination scale
Measured: Month 9
Change in weight bias internalisation from baseline to 9 months
measured via the Modified Weight Bias Internalization Scale (WBIS-M)
Measured: Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start10 Jun 2021
- Primary completion15 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled with two parallel arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- SENS laboratory, Univ. Grenoble Alpes, INRAE, UNH, CRNH Auvergne, Clermont Auvergne University, Kiplin, I-SITE Clermont Auvergne Project 20-25
- Responsible party
- Sponsor
- Investigators
- Martine Duclos, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887077
- Sponsor's protocol ID
- RBHP 2020 DUCLOS 2
- Other IDs
- 2020-A03091-38
- Acronym
- DIPPAO
- Status last verified
- Jul 2026
- First submitted
- 3 May 2021
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share de-identified data associated with the collected samples by depositing these data at the Open Science Framework (OSF) repository. The storage will be in Germany (Frankfurt). Data will include demographic, anthropometric, and physical measurements along with data from questionnaires and intervention adherence. We agree that we will identify where the data will be available and how to access the data in any publications and presentations that we author about these data.
Publications
Mazeas A, Chalabaev A, Blond M, Mourgues C, Pereira B, Duclos M. Effect of a Digital Health Physical Activity Program Integrating Gamification for Obesity Management in Comparison With Usual Care: Randomized Controlled Trial With an Ideographic Approach. J Med Internet Res. 2025 Nov 28;27:e78376. doi: 10.2196/78376.
PubMed 41328457Mazeas A, Chalabaev A, Blond M, Pereira B, Duclos M. Digital intervention promoting physical activity among obese people (DIPPAO) randomised controlled trial: study protocol. BMJ Open. 2022 Jun 16;12(6):e058015. doi: 10.1136/bmjopen-2021-058015.
PubMed 35710254
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04887077
- Acronym / sponsor ID
- DIPPAO / RBHP 2020 DUCLOS 2
- Conditions
- Obesity, Diabete Type 2
- Keywords
- eHealth, Physical activity, Gamification, Mobile app, Behavior change, Cost-utility, Weight stigma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- SENS laboratory, Univ. Grenoble Alpes, INRAE, UNH, CRNH Auvergne, Clermont Auvergne University, Kiplin, I-SITE Clermont Auvergne Project 20-25
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled with two parallel arms.
| Arm | Type | Receives |
|---|---|---|
| Kiplin intervention | Experimental | Device: KiplinKiplin intervention composed of the access to a mobile app and to telecoaching sessions. The number of teleocaching sessions per week will decrease over 3 months. |
| face-to-face supervised PA (usual care at the University Hospital of Clermont-Ferrand, France) | Active comparator | Behavioral: face-to-facethree-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KiplinThe 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. | Device | Kiplin intervention |
| face-to-facethree-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions. | Behavioural | face-to-face supervised PA (usual care at the University Hospital of Clermont-Ferrand, France) |
Primary outcome
Change in daily physical activity from baseline to 3 months
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)
21 secondary outcomes
Change in body composition (BMI) from baseline to 9 months
Time frame: Month 9
Change in body composition from baseline to 9 months
Time frame: Month 9
Change in daily physical activity from baseline to 9 months
Time frame: Month 9
Change in physical activity level from baseline to 9 months
Time frame: Month 9
Change in moderate-to-vigorous physical activity (MVPA) from baseline to 9 months
Time frame: Month 9
Change in light physical activity (LPA) from baseline to 9 months
Time frame: Month 9
Change in sedentary time from baseline to 9 months
Time frame: Month 9
Change in self-reported physical activity from baseline to 9 months
Time frame: Month 9
Change in six minute walking distance from baseline to 9 months
Time frame: Month 9
Change in muscular strength of the upper limbs from baseline to 9 months
Time frame: Month 9
Change in muscular strength of the lower limbs from baseline to 9 months
Time frame: Month 9
Programme adherence
Time frame: Month 3
Change in quality of life from baseline to 9 months
Time frame: Month 9
Cost-utility analysis
Time frame: Month 9
Perceived enjoyment of physical activity at the end of the intervention
Time frame: Month 3
Social identification at the end of the intervention
Time frame: Month 3
Psychological needs satisfaction at the end of the intervention
Time frame: Month 3
Change in motivation toward physical activity from baseline to 9 months
Time frame: Month 9
Change in weight stigma concerns from baseline to 9 months
Time frame: Month 9
Change in perceived daily discrimination from baseline to 9 months
Time frame: Month 9
Change in weight bias internalisation from baseline to 9 months
Time frame: Month 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Results publication: PubMed 41328457Mazeas A, Chalabaev A, Blond M, Mourgues C, Pereira B, Duclos M. Effect of a Digital Health Physical Activity Program Integrating Gamification for Obesity Management in Comparison With Usual Care: Randomized Controlled Trial With an Ideographic Approach. J Med Internet Res. 2025 Nov 28;27:e78376. doi: 10.2196/78376.
- Derived from this study: PubMed 35710254Mazeas A, Chalabaev A, Blond M, Pereira B, Duclos M. Digital intervention promoting physical activity among obese people (DIPPAO) randomised controlled trial: study protocol. BMJ Open. 2022 Jun 16;12(6):e058015. doi: 10.1136/bmjopen-2021-058015.
- Individual participant dataSharing planned: Yes. We will share de-identified data associated with the collected samples by depositing these data at the Open Science Framework (OSF) repository. The storage will be in Germany (Frankfurt). Data will include demographic, anthropometric, and physical measurements along with data from questionnaires and intervention adherence. We agree that we will identify where the data will be available and how to access the data in any publications and presentations that we author about these data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Duclos principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kiplin and face-to-face in people with Obesity and Diabete Type 2, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily physical activity from baseline to 3 months (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04887077, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.