ObesityNCT05884606
The Allurion Digital Behaviour Change Intervention
A study testing Allurion Digital Behaviour Change Intervention in people with Obesity, run by Allurion Technologies at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Allurion Digital Behaviour Change Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 19 Jun 2021to 6 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Any condition contraindicated for the Allurion Gastric Balloon System as specified in the Instructions for Use
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Netherlands2 sites
Nederlandse Obesitas Kliniek (NOK)
Amsterdam, 1043
Allurion Kliniek
Nederland, AB Hilversum, 1217
United Kingdom2 sites
Monkhouse Surgical
Bromley, Kent, BR1 3RA
Medizen Aesthetic Clinic
Sutton Coldfield, Birmingham, B74 2UG
About this study
Official title: A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention
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.
Read the 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
- Conditions
- Obesity
- Being tested
- Allurion Digital Behaviour Change Intervention
- Keywords
- Intragastric balloon
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allurion Digital Behaviour Change InterventionDevice
The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity.
| Study group | Role | What they receive |
|---|---|---|
| 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:
* 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 Receives: Device: Allurion Digital Behaviour Change Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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
Measured: 6 and 12 months
Patient satisfaction
Patient self-reported intervention satisfaction via non-validated survey measures
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start19 Jun 2021
- Primary completion6 May 2022
- Study completion6 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective Single Arm Cohort Pilot Study
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allurion Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Sacher, RD, PhD, Principal investigator, Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884606
- Sponsor's protocol ID
- TRL-1000-0005
- Status last verified
- May 2023
- First submitted
- 1 Jul 2021
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared with other researchers
Publications
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.
PubMed 39083340
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention
- ClinicalTrials.gov ID
- NCT05884606
- Acronym / sponsor ID
- TRL-1000-0005
- Conditions
- Obesity
- Keywords
- Intragastric balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Allurion TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 Nov 2022 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective Single Arm Cohort Pilot Study
| Arm | Type | Receives |
|---|---|---|
| non-randomized, pilot study | Experimental | Device: Allurion Digital Behaviour Change InterventionThis 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: * 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Any condition contraindicated for the Allurion Gastric Balloon System as specified in the Instructions for Use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allurion Digital Behaviour Change InterventionThe Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity. | Device | non-randomized, pilot study |
Primary outcome
Change in percent total body weight loss (percent TBWL)
Time frame: 6 months
The primary outcome measure for this intervention is the change in percent total body weight loss (percent TBWL).
10 secondary outcomes
Change in mental wellbeing
Time frame: 6 and 12 months
Change in anxiety
Time frame: 6 and 12 months
Change in quality of life
Time frame: 6 and 12 months
Change in loss of control over eating
Time frame: 6 and 12 months
Change in self-efficacy
Time frame: 6 and 12 months
Change in barriers to exercise
Time frame: 6 and 12 months
Time spent in physical activity steps (daily number of steps)
Time frame: 6 and 12 months
Engagement with Health Coaching
Time frame: 6 and 12 months
Engagement with the mobile and web app
Time frame: 6 and 12 months
Patient satisfaction
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 39083340Sacher 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.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Sacher, RD, PhD principal investigator
Director
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allurion Digital Behaviour Change Intervention in people with Obesity, run by Allurion Technologies at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent total body weight loss (percent TBWL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.