Clinical trial NCT05884606: The Allurion Digital Behaviour Change Intervention
Official title: A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Intragastric balloon
Lead sponsor: Allurion Technologies
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Single Arm Cohort Pilot Study
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in percent total body weight loss (percent TBWL)
timeFrame: 6 months
Secondary outcomes:
measure: Change in mental wellbeing
timeFrame: 6 and 12 months
measure: Change in anxiety
timeFrame: 6 and 12 months
measure: Change in quality of life
timeFrame: 6 and 12 months
measure: Change in loss of control over eating
timeFrame: 6 and 12 months
measure: Change in self-efficacy
timeFrame: 6 and 12 months
measure: Change in barriers to exercise
timeFrame: 6 and 12 months
measure: Time spent in physical activity steps (daily number of steps)
timeFrame: 6 and 12 months
measure: Engagement with Health Coaching
timeFrame: 6 and 12 months
measure: Engagement with the mobile and web app
timeFrame: 6 and 12 months
measure: Patient satisfaction
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Nederland
country: Netherlands
facility: Allurion Kliniek
state: AB Hilversum
city: Amsterdam
country: Netherlands
facility: Nederlandse Obesitas Kliniek (NOK)
city: Sutton Coldfield
country: United Kingdom
facility: Medizen Aesthetic Clinic
state: Birmingham
city: Bromley
country: United Kingdom
facility: Monkhouse Surgical
state: Kent
Study officials:
affiliation: Director
name: Paul Sacher, RD, PhD
role: PRINCIPAL_INVESTIGATOR
References: