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Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO) (DIPPAO)

Primary Purpose

Obesity, Diabete Type 2

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Kiplin
face-to-face
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring eHealth, Physical activity, Gamification, Mobile app, Behavior change, Cost-utility, Weight stigma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 deprived of their liberty by judicial or administrative decision.
  • Subject refusing to sign the written consent to participate.
  • Subject participating in another study.

Sites / Locations

  • CHU de Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Kiplin intervention

face-to-face supervised PA (usual care at the University Hospital of Clermont-Ferrand, France)

Arm Description

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.

three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Change in body composition (BMI) from baseline to 9 months
in kg/m2
Change in body composition from baseline to 9 months
evaluated by bioelectrical impedance analysis
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)
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)
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).
Change in light physical activity (LPA) from baseline to 9 months
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Change in sedentary time from baseline to 9 months
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Change in self-reported physical activity from baseline to 9 months
measured using the RPAQ
Change in six minute walking distance from baseline to 9 months
measured via the 6-minute walking test
Change in muscular strength of the upper limbs from baseline to 9 months
measured via handgrip measurements
Change in muscular strength of the lower limbs from baseline to 9 months
measured via isokinetic dynamometer
Programme adherence
number of APA sessions attended. Application engagement and utilization for the experimental group only
Change in quality of life from baseline to 9 months
measured via the EQ-5D
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
Perceived enjoyment of physical activity at the end of the intervention
measured using the Physical Activity Enjoyment Scale (PACES)
Social identification at the end of the intervention
measured via the In-group identification questionnaire
Psychological needs satisfaction at the end of the intervention
measured via the Psychological Need Satisfaction in Exercise Scale (PNSES)
Change in motivation toward physical activity from baseline to 9 months
Autonomous and controlled motivation toward physical activity via the EMAPS.
Change in weight stigma concerns from baseline to 9 months
measured using the scale developed by Hunger and Major
Change in perceived daily discrimination from baseline to 9 months
measured via the everyday discrimination scale
Change in weight bias internalisation from baseline to 9 months
measured via the Modified Weight Bias Internalization Scale (WBIS-M)

Full Information

First Posted
May 3, 2021
Last Updated
March 1, 2022
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
SENS laboratory, Univ. Grenoble Alpes, INRAE, UNH, CRNH Auvergne, Clermont Auvergne University, Kiplin, I-SITE Clermont Auvergne Project 20-25
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1. Study Identification

Unique Protocol Identification Number
NCT04887077
Brief Title
Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO)
Acronym
DIPPAO
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
SENS laboratory, Univ. Grenoble Alpes, INRAE, UNH, CRNH Auvergne, Clermont Auvergne University, Kiplin, I-SITE Clermont Auvergne Project 20-25

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabete Type 2
Keywords
eHealth, Physical activity, Gamification, Mobile app, Behavior change, Cost-utility, Weight stigma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, controlled with two parallel arms.
Masking
InvestigatorOutcomes Assessor
Masking Description
Research assistants collecting data will be blinded to the treatment allocation. Double blinding is nevertheless not possible in such interventions because allocation concealment is impossible for participants.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kiplin intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
face-to-face supervised PA (usual care at the University Hospital of Clermont-Ferrand, France)
Arm Type
Active Comparator
Arm Description
three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions.
Intervention Type
Device
Intervention Name(s)
Kiplin
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
face-to-face
Intervention Description
three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions.
Primary Outcome Measure Information:
Title
Change in daily physical activity from baseline to 3 months
Description
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 3
Secondary Outcome Measure Information:
Title
Change in body composition (BMI) from baseline to 9 months
Description
in kg/m2
Time Frame
Month 9
Title
Change in body composition from baseline to 9 months
Description
evaluated by bioelectrical impedance analysis
Time Frame
Month 9
Title
Change in daily physical activity from baseline to 9 months
Description
measured as the daily step count assessed via the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)
Time Frame
Month 9
Title
Change in physical activity level from baseline to 9 months
Description
total physical activity (minutes/day) measured using the Garmin Vivofit 3 (Garmin International Inc., Olathe, KS, USA)
Time Frame
Month 9
Title
Change in moderate-to-vigorous physical activity (MVPA) from baseline to 9 months
Description
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Time Frame
Month 9
Title
Change in light physical activity (LPA) from baseline to 9 months
Description
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Time Frame
Month 9
Title
Change in sedentary time from baseline to 9 months
Description
measured using a tri-axial accelerometer (ActiGraph GT3x; ActiGraph LLC, Pensacola, FL, USA).
Time Frame
Month 9
Title
Change in self-reported physical activity from baseline to 9 months
Description
measured using the RPAQ
Time Frame
Month 9
Title
Change in six minute walking distance from baseline to 9 months
Description
measured via the 6-minute walking test
Time Frame
Month 9
Title
Change in muscular strength of the upper limbs from baseline to 9 months
Description
measured via handgrip measurements
Time Frame
Month 9
Title
Change in muscular strength of the lower limbs from baseline to 9 months
Description
measured via isokinetic dynamometer
Time Frame
Month 9
Title
Programme adherence
Description
number of APA sessions attended. Application engagement and utilization for the experimental group only
Time Frame
Month 3
Title
Change in quality of life from baseline to 9 months
Description
measured via the EQ-5D
Time Frame
Month 9
Title
Cost-utility analysis
Description
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 9
Title
Perceived enjoyment of physical activity at the end of the intervention
Description
measured using the Physical Activity Enjoyment Scale (PACES)
Time Frame
Month 3
Title
Social identification at the end of the intervention
Description
measured via the In-group identification questionnaire
Time Frame
Month 3
Title
Psychological needs satisfaction at the end of the intervention
Description
measured via the Psychological Need Satisfaction in Exercise Scale (PNSES)
Time Frame
Month 3
Title
Change in motivation toward physical activity from baseline to 9 months
Description
Autonomous and controlled motivation toward physical activity via the EMAPS.
Time Frame
Month 9
Title
Change in weight stigma concerns from baseline to 9 months
Description
measured using the scale developed by Hunger and Major
Time Frame
Month 9
Title
Change in perceived daily discrimination from baseline to 9 months
Description
measured via the everyday discrimination scale
Time Frame
Month 9
Title
Change in weight bias internalisation from baseline to 9 months
Description
measured via the Modified Weight Bias Internalization Scale (WBIS-M)
Time Frame
Month 9
Other Pre-specified Outcome Measures:
Title
Perceived vulnerability toward COVID-19
Description
measured using the perceived vulnerability questionnaire
Time Frame
Month 9
Title
Perceived digitalization
Description
measured using a single item
Time Frame
Month 9
Title
Perceived exertion during the APA sessions
Description
measured via the Borg scale
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 deprived of their liberty by judicial or administrative decision. Subject refusing to sign the written consent to participate. Subject participating in another study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LACLAUTRE
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martine Duclos
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lise Laclautre
Phone
+33473754963
Email
promo_interne_drci@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Martine Duclos
First Name & Middle Initial & Last Name & Degree
Valérie Julian

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be available via a public OSF project that will be accessible by everyone. We agree to deposit outcome data into the OSF repository as soon as possible but no later than within two years after the completion of the trial or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier.
Citations:
PubMed Identifier
35710254
Citation
Mazeas 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.
Results Reference
derived

Learn more about this trial

Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO)

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