ObesityBeatMoveNCT06486961
Effect of Walking With Music in Obese People (BeatMove)
A study testing BeatMove Application, BeatMove Application without synchronized music and BeatMove Application without music in people with Obesity and Sedentary Behavior, run by Clinique Beau Soleil at 1 site in France.
Trial summary
For several decades, scientists have reported encouraging effects of physical activity on functional capacities and quality of life among patients with obesity. However, regular daily physical activity remains limited in these individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Sedentary Behavior
- What is being tested?
- BeatMove Application, BeatMove Application without synchronized music and BeatMove Application without music
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2023to 30 Nov 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to walk continuously for 15 minutes without the use of any assistive devices (e.g., cane, walker) or human assistance.
- Have a Body Mass Index (BMI) greater than 25 and less than 45.
- Understand the nature, purpose, and methodology of the study.
- Agree to cooperate during evaluations.
- Have signed the informed consent form.
- Be affiliated with a social security scheme or equivalent.
Who cannot join
- Marcher plus de 30 minutes, 5 fois par semaine
- Présenter une insuffisance cardiaque ou respiratoire sévère contre indiquant une rééducation à la marche.
- Majeurs faisant l'objet d'une protection légale ou hors d'état d'exprimer leur consentement (Article 1121-8 du CSP)
- Personnes vulnérables (Article L 1121-6 du CSP)
- Privation de liberté par décision judiciaire ou administrative
- Forte probabilité de non-compliance au protocole ou d'abandon en cours d'étude
- Femmes enceintes/allaitantes
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique Beau Soleil
Montpellier, Hérault, 34070
Valérie Cochen De Cock, M.D., 0033467789847, valerie.cochen@gmail.com
Valérie Cochen De Cock, M.D.
About this study
Official title: Randomized Controlled Study of the Effectiveness of a Self-rehabilitation Program for Walking Using Adapted Musical Auditory Rhythmic Stimulation, Delivered by BeatMove, in People Suffering From Obesity
For several decades, scientists have reported encouraging effects of physical activity on functional capacities and quality of life among patients with obesity. However, regular daily physical activity remains limited in these individuals. People with obesity generally show lower adherence to physical activity, with 40% not meeting the recommendations of 2.5 to 3 hours of moderate physical activity per week set by the French National Authority for Health to be considered physically active. Since physical activity is the primary energy expenditure that can be targeted, the priority is to make it appealing through exercise programs tailored to individual needs, abilities, and preferences. To achieve this, using music to facilitate walking appears relevant. Studies show that individuals adhere to physical activity and incorporate it into their routines only if they find it enjoyable. Walking to music is more motivating and enjoyable. Moreover, the rhythm of music enhances the functioning of biological systems involved in walking. Tailored physical activity is a major preventive lever to implement for individuals with obesity. It is essential during the initial weight loss phase and during weight maintenance.
The overall objective of this study is to propose a digital tool capable of modifying the behavior of individuals with obesity to reduce sedentary behavior in their daily lives. Synchronized walking to the rhythm of music should help train obese patients towards a virtuous cycle leading to slowed weight gain, reduced associated health problems, and improvements in mental health and quality of life.
Read the detailed description
This program involves outdoor walking sessions, conducted 5 times a week for 15 to 30 minutes each, over a consecutive 3-month period using the BeatMove device. The device can be adjusted to deliver music or not, and the music can either be synchronized to the participant's walking pace or randomly timed.
During the week preceding self-rehabilitation, participants will wear a thigh-mounted accelerometer to establish a baseline representative of their daily habits. Before each walking session, participants will assess their motivation using a visual analog scale within the application. After each session, they will evaluate their perceived exertion using the Borg Scale.
In the BeatMove group, the music delivered will be tailored to match the walking pace of the participants. Throughout the session, the music rhythm will subtly increase by 20% to accelerate the participant's walking pace, thereby guiding them towards their optimal cadence based on their assessed level and motivation at the start of the session.
In the group with randomly timed music, the music delivery does not consider the participant's state and plays random music.
Finally, in the group without music, the walking self-rehabilitation program will be guided solely by the audio instructions provided by the application.
In all three groups, participants will be equipped:
Throughout the day with a thigh-mounted "fibion sens" accelerometer. During the walking self-rehabilitation session with ankle step sensors to record walking parameters while delivering music tailored to their walking pace.
- Conditions
- Obesity, Sedentary Behavior
- Being tested
- BeatMove Application, BeatMove Application without synchronized music, BeatMove Application without music
- Medical subject headings
- Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeatMove ApplicationDevice
The participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove application delivers synchronized music adapted to the patient walking.
The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts.
BeatMove Application without synchronized musicDevice
The participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove Application delivers random music at random tempo.
The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts.
BeatMove Application without musicDevice
The participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove Application does not deliver music. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts.
| Study group | Role | What they receive |
|---|---|---|
| BeatMove Experimental Group | Experimental | The participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove application delivers synchronized music adapted to the patient walking.
The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts. Receives: Device: BeatMove Application |
| Control Group with Music at Random Tempo | Active comparator | The participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove Application delivers random music at random tempo.
The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts. Receives: Device: BeatMove Application without synchronized music |
| Control Group without Music | Active comparator | The participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove Application does not deliver music. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts. Receives: Device: BeatMove Application without music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in average daily step count
The primary outcome measure is the variation in average daily step count across the three groups during the week (7 consecutive days) prior to the start of home-based self-rehabilitation and the final week of self-rehabilitation. These steps will be measured using "fibion sens" accelerometers under ecological conditions.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Feb 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Beau Soleil
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Vincent Attalin, Dr, Principal investigator, Clinique Beau Soleil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486961
- Sponsor's protocol ID
- 2022-A01544-39
- Acronym
- BeatMove
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of the Effectiveness of a Self-rehabilitation Program for Walking Using Adapted Musical Auditory Rhythmic Stimulation, Delivered by BeatMove, in People Suffering From Obesity
- ClinicalTrials.gov ID
- NCT06486961
- Acronym / sponsor ID
- BeatMove / 2022-A01544-39
- Conditions
- Obesity, Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Clinique Beau SoleilUniversity, hospital or other
- Collaborators
- Université Montpellier
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 5 Jul 2024 (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.
For several decades, scientists have reported encouraging effects of physical activity on functional capacities and quality of life among patients with obesity. However, regular daily physical activity remains limited in these individuals. People with obesity generally show lower adherence to physical activity, with 40% not meeting the recommendations of 2.5 to 3 hours of moderate physical activity per week set by the French National Authority for Health to be considered physically active. Since physical activity is the primary energy expenditure that can be targeted, the priority is to make it appealing through exercise programs tailored to individual needs, abilities, and preferences. To achieve this, using music to facilitate walking appears relevant. Studies show that individuals adhere to physical activity and incorporate it into their routines only if they find it enjoyable. Walking to music is more motivating and enjoyable. Moreover, the rhythm of music enhances the functioning of biological systems involved in walking. Tailored physical activity is a major preventive lever to implement for individuals with obesity. It is essential during the initial weight loss phase and during weight maintenance.
The overall objective of this study is to propose a digital tool capable of modifying the behavior of individuals with obesity to reduce sedentary behavior in their daily lives. Synchronized walking to the rhythm of music should help train obese patients towards a virtuous cycle leading to slowed weight gain, reduced associated health problems, and improvements in mental health and quality of life.
Detailed description
This program involves outdoor walking sessions, conducted 5 times a week for 15 to 30 minutes each, over a consecutive 3-month period using the BeatMove device. The device can be adjusted to deliver music or not, and the music can either be synchronized to the participant's walking pace or randomly timed.
During the week preceding self-rehabilitation, participants will wear a thigh-mounted accelerometer to establish a baseline representative of their daily habits. Before each walking session, participants will assess their motivation using a visual analog scale within the application. After each session, they will evaluate their perceived exertion using the Borg Scale.
In the BeatMove group, the music delivered will be tailored to match the walking pace of the participants. Throughout the session, the music rhythm will subtly increase by 20% to accelerate the participant's walking pace, thereby guiding them towards their optimal cadence based on their assessed level and motivation at the start of the session.
In the group with randomly timed music, the music delivery does not consider the participant's state and plays random music.
Finally, in the group without music, the walking self-rehabilitation program will be guided solely by the audio instructions provided by the application.
In all three groups, participants will be equipped:
Throughout the day with a thigh-mounted "fibion sens" accelerometer. During the walking self-rehabilitation session with ankle step sensors to record walking parameters while delivering music tailored to their walking pace.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BeatMove Experimental Group | Experimental | Device: BeatMove ApplicationThe participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove application delivers synchronized music adapted to the patient walking. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts. |
| Control Group with Music at Random Tempo | Active comparator | Device: BeatMove Application without synchronized musicThe participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove Application delivers random music at random tempo. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts. |
| Control Group without Music | Active comparator | Device: BeatMove Application without musicThe participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove Application does not deliver music. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able to walk continuously for 15 minutes without the use of any assistive devices (e.g., cane, walker) or human assistance.
- Have a Body Mass Index (BMI) greater than 25 and less than 45.
- Understand the nature, purpose, and methodology of the study.
- Agree to cooperate during evaluations.
- Have signed the informed consent form.
Key exclusion criteria (7 listed)
- Marcher plus de 30 minutes, 5 fois par semaine
- Présenter une insuffisance cardiaque ou respiratoire sévère contre indiquant une rééducation à la marche.
- Majeurs faisant l'objet d'une protection légale ou hors d'état d'exprimer leur consentement (Article 1121-8 du CSP)
- Personnes vulnérables (Article L 1121-6 du CSP)
- Privation de liberté par décision judiciaire ou administrative
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 |
|---|---|---|
| BeatMove ApplicationThe participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove application delivers synchronized music adapted to the patient walking. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts. | Device | BeatMove Experimental Group |
| BeatMove Application without synchronized musicThe participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove Application delivers random music at random tempo. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts. | Device | Control Group with Music at Random Tempo |
| BeatMove Application without musicThe participant walks for 15 to 30 minutes a day, 5 day a week for 3 months. During the walking session, BeatMove Application does not deliver music. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts. | Device | Control Group without Music |
Primary outcome
Differences in average daily step count
Time frame: Up to 3 months
The primary outcome measure is the variation in average daily step count across the three groups during the week (7 consecutive days) prior to the start of home-based self-rehabilitation and the final week of self-rehabilitation. These steps will be measured using "fibion sens" accelerometers under ecological conditions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
Vincent Attalin, Dr principal investigator
Clinique Beau Soleil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BeatMove Application, BeatMove Application without synchronized music and BeatMove Application without music in people with Obesity and Sedentary Behavior, run by Clinique Beau Soleil 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 7 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: status not confirmed, as of the sponsor's last update on 16 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice Bourdon, Phd student (0033 6 95 25 13 98, alice.bourdon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in average daily step count (time frame: Up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2024.