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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Allurion Digital Behaviour Change Intervention

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1043
    • Nederlandse Obesitas Kliniek (NOK)
  • AB Hilversum
    • Nederland, AB Hilversum, Netherlands, 1217
      • Allurion Kliniek
• United Kingdom
  • Birmingham
    • Sutton Coldfield, Birmingham, United Kingdom, B74 2UG
      • Medizen Aesthetic Clinic
  • Kent
    • Bromley, Kent, United Kingdom, BR1 3RA
      • Monkhouse Surgical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Device: Allurion Digital Behaviour Change Intervention; The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Allurion Technologies
• Investigators: Principal Investigator: Paul Sacher, RD, PhD, Director

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2021
• Primary Completion (Actual): May 6, 2022
• Study Completion (Actual): November 6, 2022

Study Registration Dates

• First Submitted: July 1, 2021
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Intragastric balloon
• Other Study ID Numbers: TRL-1000-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes