Obesity
Conditions
Keywords
Intragastric balloon
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
Interventions
DEVICEAllurion Digital Behaviour Change Intervention
The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity.
Sponsors
Allurion Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective Single Arm Cohort Pilot Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent total body weight loss (percent TBWL) | 6 months | The primary outcome measure for this intervention is the change in percent total body weight loss (percent TBWL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in anxiety | 6 and 12 months | \- Change in anxiety as assessed by the the Generalized Anxiety Disorder scale. 0 (lowest anxiety) - 21 (highest anxiety) |
| Change in quality of life | 6 and 12 months | \- 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) |
| Change in loss of control over eating | 6 and 12 months | \- 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) |
| Change in self-efficacy | 6 and 12 months | \- Change in self-efficacy as assessed by the Weight Efficacy Lifestyle Questionnaire 0 (least confidence in not overeating) - 80 (most confidence) |
| Change in mental wellbeing | 6 and 12 months | \- Change in mental wellbeing as assessed by the The Warwick-Edinburgh Mental Well-being Scale. 14 (lowest mood) - 70 (highest mood) |
| Time spent in physical activity steps (daily number of steps) | 6 and 12 months | 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. |
| Engagement with Health Coaching | 6 and 12 months | 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). |
| Engagement with the mobile and web app | 6 and 12 months | 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 |
| Patient satisfaction | 6 and 12 months | Patient self-reported intervention satisfaction via non-validated survey measures |
| Change in barriers to exercise | 6 and 12 months | \- Change in barriers to exercise as assessed by the Barriers to Being Active Quiz 0 (least barriers to activity) - 12 (most barriers) |
Countries
Netherlands, United Kingdom
Outcome results
None listed