The Allurion Digital Behaviour Change Intervention

Obesity Clinical Trial

Official title:

A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05884606
• Other study ID #: TRL-1000-0005
• Status: Completed
• Phase: N/A
• Start date: June 19, 2021
• Est. completion date: November 6, 2022

Study information

• Verified date: May 2023
• Source: Allurion Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 6, 2022
• Est. primary completion date: May 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Netherlands	Nederlandse Obesitas Kliniek (NOK)	Amsterdam
Netherlands	Allurion Kliniek	Nederland	AB Hilversum
United Kingdom	Monkhouse Surgical	Bromley	Kent
United Kingdom	Medizen Aesthetic Clinic	Sutton Coldfield	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Allurion Technologies

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient satisfaction	Patient self-reported intervention satisfaction via non-validated survey measures	6 and 12 months