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Completed

NCT Number: NCT05884606

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allurion Kliniek, Nederland, AB Hilversum, Netherlands

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allurion Digital Behaviour Change Intervention

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change in mental wellbeing

    Time frame: 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)

  2. Change in anxiety

    Time frame: 6 and 12 months

    • Change in anxiety as assessed by the the Generalized Anxiety Disorder scale. 0 (lowest anxiety) - 21 (highest anxiety)

  3. Change in quality of life

    Time frame: 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)

  4. Change in loss of control over eating

    Time frame: 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)

  5. Change in self-efficacy

    Time frame: 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)

  6. Change in barriers to exercise

    Time frame: 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)

  7. Time spent in physical activity steps (daily number of steps)

    Time frame: 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.

  8. Engagement with Health Coaching

    Time frame: 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).

  9. Engagement with the mobile and web app

    Time frame: 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

  10. Patient satisfaction

    Time frame: 6 and 12 months

    Patient self-reported intervention satisfaction via non-validated survey measures

Sponsors and collaborators

Lead sponsor

Allurion Technologies

Industry

Registry information

Official study title

A Prospective Pilot Study of the Allurion Digital Behaviour Change Intervention

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2023
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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