A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention

A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention - DBCI

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49911

Enrollment

Registered

2021-07-26

Start date

2021-08-27

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

obesitas Obesity overweight

Interventions

All participants will undergo standard treatment with the commercially available Elipse Gastric Balloon System in accordance with the approved Instructions for Use. The Elipse Gastric Balloon System

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Elipse Gastric Balloon System placement in accordance with the approved Indications for Use Age 21 to 65 years of age BMI >= 27 Weight

Exclusion criteria

Exclusion criteria: Any condition contraindicated for the Elipse Gastric Balloon System as specified in the Instructions for Use

Design outcomes

Primary

Measure	Time frame
The primary outcome measure for this intervention is the change in % total body weight loss (%TBWL).	—

Secondary

Measure	Time frame
Change in psychological outcomes*known to influence successful weight loss and maintenance including mood, anxiety, Health-related Quality of Life (QoL) and overall wellbeing; self-efficacy and ability to self-regulate emotions, thoughts and behaviours relating to weight management. Changes in BMI, body composition, time spent in physical activity (aerobic exercise and steps), sleep, heart rate and dietary intake (calories and macronutrients). Acceptability, barriers and facilitators to implementing the DBCI from a participant and provider perspective. Participant engagement with DBCI and provider after-care support.	—

Measure

Time frame

Change in psychological outcomes*known to influence successful weight loss and maintenance including mood, anxiety, Health-related Quality of Life (QoL) and overall wellbeing; self-efficacy and ability to self-regulate emotions, thoughts and behaviours relating to weight management. Changes in BMI, body composition, time spent in physical activity (aerobic exercise and steps), sleep, heart rate and dietary intake (calories and macronutrients). Acceptability, barriers and facilitators to implementing the DBCI from a participant and provider perspective. Participant engagement with DBCI and provider after-care support.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)