Effect of Walking With Music in Obese People (BeatMove) (BeatMove)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Sedentary Behavior
• Intervention / Treatment: Device: BeatMove Application; Device: BeatMove Application without synchronized music; Device: BeatMove Application without music

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alice Bourdon, Phd student; Phone Number: 0033 6 95 25 13 98; Email: alice.bourdon@hotmail.com

Study Locations

• France
  • Hérault
    • Montpellier, Hérault, France, 34070
      • Recruiting
      • Clinique Beau Soleil
      • Contact: Valérie Cochen De Cock, M.D.; Phone Number: 0033467789847; Email: valerie.cochen@gmail.com
      • Principal Investigator: Valérie Cochen De Cock, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BeatMove Experimental Group; 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.	Device: BeatMove Application; 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.
Active Comparator: Control Group with Music at Random Tempo; 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.	Device: BeatMove Application without synchronized music; 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.
Active Comparator: Control Group without Music; 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.	Device: BeatMove Application without music; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 months

Collaborators and Investigators

• Sponsor: Clinique Beau Soleil
• Collaborators: Université Montpellier
• Investigators: Principal Investigator: Vincent Attalin, Dr, Clinique Beau Soleil

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 2022-A01544-39

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No