The Allurion Digital Behaviour Change Intervention

NCT05884606 | Completed FDA Device

• 1 other identifier: TRL-1000-0005
• Study Type: interventional
• Target: 107
• Locations: 2 countries
• Sites: 4

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.

Conditions

Obesity

Keywords

Intragastric balloon

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Change in mental wellbeing

  6 and 12 months

• Change in anxiety

  6 and 12 months

• Change in quality of life

  6 and 12 months

• Change in loss of control over eating

  6 and 12 months

• Change in self-efficacy

  6 and 12 months

Study Arms (1)

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

Device: Allurion Digital Behaviour Change Intervention

Interventions

Allurion Digital Behaviour Change Intervention DEVICE

The Allurion DBCI adheres to current National Institute for Health and Care Excellence (NICE) guidance for obesity.

non-randomized, pilot study

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Any condition contraindicated for the Allurion Gastric Balloon System as specified in the Instructions for Use

Sponsors & Collaborators

• Allurion Technologies: lead

Study Sites (4)

Allurion Kliniek

Nederland, AB Hilversum, 1217, Netherlands

Location

Nederlandse Obesitas Kliniek (NOK)

Amsterdam, 1043, Netherlands

Location

Medizen Aesthetic Clinic

Sutton Coldfield, Birmingham, B74 2UG, United Kingdom

Location

Monkhouse Surgical

Bromley, Kent, BR1 3RA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 39083340 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Sacher, RD, PhD

  Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective Single Arm Cohort Pilot Study

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: June 1, 2023
• Study Start: June 19, 2021
• Primary Completion: May 6, 2022
• Study Completion: November 6, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2); GB (2)