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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity.
Allurion Kliniek
Nederland, AB Hilversum, Netherlands
Nederlandse Obesitas Kliniek (NOK)
Amsterdam, Netherlands
Medizen Aesthetic Clinic
Sutton Coldfield, Birmingham, United Kingdom
Monkhouse Surgical
Bromley, Kent, United Kingdom
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).
Time frame: 6 months
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 6 and 12 months
Patient satisfaction
Patient self-reported intervention satisfaction via non-validated survey measures
Time frame: 6 and 12 months