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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 Allurionâ„¢ 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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-randomized, pilot study | Experimental | 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:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allurion Digital Behaviour Change Intervention | Device | The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Any condition contraindicated for the Allurion Gastric Balloon System as specified in the Instructions for Use
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| Name | Affiliation | Role |
|---|---|---|
| Paul Sacher, RD, PhD | Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allurion Kliniek | Nederland | AB Hilversum | 1217 | Netherlands | ||
| Nederlandse Obesitas Kliniek (NOK) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39083340 | Derived | Sacher PM, Fulton E, Rogers V, Wilson J, Gramatica M, Dent JE, Aarts EO, Eccleston D, Greve JW, Palm-Meinders I, Chuttani R. Impact of a Health Coach-Led, Text-Based Digital Behavior Change Intervention on Weight Loss and Psychological Well-Being in Patients Receiving a Procedureless Intragastric Balloon Program: Prospective Single-Arm Study. JMIR Form Res. 2024 Jul 31;8:e54723. doi: 10.2196/54723. |
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No IPD will be shared with other researchers
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Prospective Single Arm Cohort Pilot Study
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- 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 |
| Amsterdam |
| 1043 |
| Netherlands |
| Medizen Aesthetic Clinic | Sutton Coldfield | Birmingham | B74 2UG | United Kingdom |
| Monkhouse Surgical | Bromley | Kent | BR1 3RA | United Kingdom |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |