Digital Intervention Promoting Physical Activity Among Obese People (DIPPAO)

NCT04887077 | Completed

• 2 other identifiers: RBHP 2020 DUCLOS 22020-A03091-38
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabete Type 2

Keywords

eHealth; Physical activity; Gamification; Mobile app; Behavior change; Cost-utility; Weight stigma

Outcome Measures

Primary Outcomes (1)

• 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)

  Month 3

Secondary Outcomes (21)

• Change in body composition (BMI) from baseline to 9 months

  Month 9

• Change in body composition from baseline to 9 months

  Month 9

• Change in daily physical activity from baseline to 9 months

  Month 9

• Change in physical activity level from baseline to 9 months

  Month 9

• Change in moderate-to-vigorous physical activity (MVPA) from baseline to 9 months

  Month 9

Other Outcomes (3)

• Perceived vulnerability toward COVID-19

  Month 9

• Perceived digitalization

  Month 9

• Perceived exertion during the APA sessions

  Month 3

Study Arms (2)

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.

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.

Behavioral: face-to-face

Interventions

Kiplin DEVICE

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.

Kiplin intervention

face-to-face BEHAVIORAL

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

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 with a known neuro-muscular pathology (i.e., myopathy, myasthenia, rhabdomyolysis, paraplegia, hemiplegia).
• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• SENS laboratory, Univ. Grenoble Alpes: collaborator
• INRAE, UNH, CRNH Auvergne, Clermont Auvergne University: collaborator
• Kiplin: collaborator
• I-SITE Clermont Auvergne Project 20-25: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Related Publications (1)

• 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.

  PMID: 35710254 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Motor Activity; Weight Prejudice

Condition Hierarchy (Ancestors)

Overweight; 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; Behavior; Prejudice; Social Behavior

Study Officials

• Martine Duclos

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled with two parallel arms.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 14, 2021
• Study Start: June 10, 2021
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

FR (1)