The Allurion Digital Behaviour Change Intervention

A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention

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.

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

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