The Allurion Digital Behaviour Change Intervention

Allurion

Status: Completed

Conditions: Obesity

Treatments: Device: Allurion Digital Behaviour Change Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT05884606

TRL-1000-0005

Details and patient eligibility

About

The proposed study is a prospective, non-randomized, pilot study to test the impact of the Allurion Digital Behaviour Change Intervention (DBCI) in participants who have been treated with the Allurion™ Gastric Balloon System. The study will include a nested qualitative and quantitative evaluations of the intervention from both the participant and Allurion provider perspective.

Full description

The study consists of the following:

• Screening and enrolment period (prior to or day of Allurion Gastric Balloon System treatment)
• All participants will take part in the Allurion DBCI for 6 months following study enrolment
• All participants will complete a 6-month follow-up assessment after completion of the Allurion DBCI

Enrollment: 107 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Allurion Gastric Balloon System placement in accordance with the approved Indications for Use
• Age 18 to 65 years of age
• BMI ≥ 27
• Weight < 180 kg
• Owns an Android or Apple smart phone
• Willing to download the Allurion App
• Willing to wear the Allurion Health Tracker Watch for the duration of the study
• Willing to use the Allurion Scale
• Proficient in reading the English language

Exclusion criteria

• Any condition contraindicated for the Allurion Gastric Balloon System as specified in the Instructions for Use

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

non-randomized, pilot study

Experimental group

Description:

This study is a prospective, non-randomized, pilot study to test the impact of the Allurion Digital Behaviour Change Intervention in participants who have been treated with the Allurion Gastric Balloon System. The study consists of the following segments: * Screening and enrolment period (prior to or day of Allurion Gastric Balloon System treatment) * All participants will take part in the Allurion DBCI for 6 months following study enrolment * All participants will complete a 6-month follow-up assessment after completion of the Allurion DBCI

Treatment:

Device: Allurion Digital Behaviour Change Intervention