Effect of Walking With Music in Obese People (BeatMove)

NCT06486961 | Recruiting DMC

• 1 other identifier: 2022-A01544-39
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Sedentary Behavior

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

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.

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.

Device: BeatMove Application without music

Interventions

BeatMove Application DEVICE

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 Experimental Group

BeatMove Application without synchronized music DEVICE

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.

Control Group with Music at Random Tempo

BeatMove Application without music DEVICE

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.

Control Group without Music

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Beau Soleil: lead
• Université Montpellier: collaborator

Study Sites (1)

Clinique Beau Soleil

Montpellier, Hérault, 34070, France

RECRUITING

MeSH Terms

Conditions

Obesity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Vincent Attalin, Dr

  Clinique Beau Soleil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Bourdon, Phd student

CONTACT

0033 6 95 25 13 98; alice.bourdon@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: February 10, 2023
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

FR (1)