The Allurion Digital Behaviour Change Intervention

Study Overview
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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.

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

Official Title
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A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention

Conditions
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Obesity

Intervention / Treatment
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* Device: Allurion Digital Behaviour Change Intervention


Participation Criteria
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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 Exclusion Criteria: - Any condition contraindicated for the Allurion Gastric Balloon System as specified in the Instructions for Use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Single Arm Cohort Pilot Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: non-randomized, pilot study<br>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 | Device: Allurion Digital Behaviour Change Intervention<br>* The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in percent total body weight loss (percent TBWL) | The primary outcome measure for this intervention is the change in percent total body weight loss (percent TBWL). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mental wellbeing | - Change in mental wellbeing as assessed by the The Warwick-Edinburgh Mental Well-being Scale. 14 (lowest mood) - 70 (highest mood) | 6 and 12 months | 
| Change in anxiety | - Change in anxiety as assessed by the the Generalized Anxiety Disorder scale. 0 (lowest anxiety) - 21 (highest anxiety) | 6 and 12 months | 
| Change in quality of life | - Change in quality of life as assessed by the Impact of Weight on Quality of Life-Lite Questionnaire Physical: 0 (lowest impact of weigh) - 28 (most impact of weight) Psychosocial: 0 (lowest impact of weight) - 52 (most impact of weight) | 6 and 12 months | 
| Change in loss of control over eating | - Change in loss of control over eating as assessed by the Loss of Control Over Eating Scale 0 (most control of eating) - 28 (least control of eating) | 6 and 12 months | 
| Change in self-efficacy | - Change in self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire 0 (least confidence in not overeating) - 80 (most confidence) | 6 and 12 months | 
| Change in barriers to exercise | - Change in barriers to exercise as assessed by the Barriers to Being Active Quiz 0 (least barriers to activity) - 12 (most barriers) | 6 and 12 months | 
| Time spent in physical activity steps (daily number of steps) | Time spent in physical activity will be measured by aerobic exercise (minutes) and steps (daily number of steps). This will be used in combination to assess physical activity. | 6 and 12 months | 
| Engagement with Health Coaching | Engagement with health coaching will be measured by categorization of the frequency and types of engagement interactions with participants. Categories of interactions will include both modes of delivery (e.g., messaging) and type of content (e.g., psychoeducation, behaviour change technique). | 6 and 12 months | 
| Engagement with the mobile and web app | Engagement with the mobile and web app will be measured by automated mobile and web App engagement will be measured by participant log-ins and number of chat messages with the health coach | 6 and 12 months | 
| Patient satisfaction | Patient self-reported intervention satisfaction via non-validated survey measures | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intragastric balloon