The Allurion Digital Behaviour Change Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-19

Study Completion Date

2022-11-06

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective Single Arm Cohort Pilot Study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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non-randomized, pilot study

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

Group Type EXPERIMENTAL

Allurion Digital Behaviour Change Intervention

Intervention Type DEVICE

The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity.

Interventions

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Allurion Digital Behaviour Change Intervention

The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity.

Intervention Type DEVICE

Eligibility Criteria

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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