Intragastric Balloon Treatment Enhances Weight Maintenance Adjunct to Low‐Energy Diet and Group‐Based Cognitive Behavioural Therapy: A Randomized Controlled Trial
Authors' conclusion
As an adjunct to group-based CBT and after LED-induced weight loss, IGB treatment provided a modest advantage in weight maintenance for up to 18 months, although safety concerns remain and long-term studies are warranted.
Study context
- Population
- Adults aged 30–65 years with BMI 32.5–45 kg/m² after a 6-month run-in of low-energy diet (LED) plus group-based cognitive-behavioural therapy (CBT); mean 43.7 years, BMI 38.0 kg/m²107 randomized
- Participants
- 126 adults
- Comparison
- CBT plus 1-year intragastric balloon (IGB) vs CBT alone after LED-induced weight loss
- IGBn = 51
- CBTn = 56reference
- Primary endpoint
- Weight change in percent between randomization (6 months from enrollment) and 18 months, relative to total body weight (TBW) at enrollment
- Follow-up
- 18 months from enrollment
Methodological detailsopen-label, 6-month run-in with LED and group-based CBT
- Open-label
- 6-month run-in with LED and group-based CBT
Primary result
As reported in the abstract
Mean weight change from randomization · up to 18 months
IGB
5.2%
mean
CBT
10.1%
mean
P < 0.001
Secondary outcomes
Achieved ≥ 5% weight loss · up to 18 months
P = 0.021
Achieved ≥ 10% weight loss · up to 18 months
P = 0.013
Weight change during LED + CBT run-in (randomized participants) · 6 months from enrollment
- Lost % of total body weight (TBW)
- −18.7% (SE: 0.64)
Metabolic parameters and health-related quality of life (HRQoL)
- Improvements in metabolic parameters and HRQoL showed no between-group differences
Original publication
Intragastric Balloon Treatment Enhances Weight Maintenance Adjunct to Low‐Energy Diet and Group‐Based Cognitive Behavioural Therapy: A Randomized Controlled Trial. Diabetes Obes Metab. Published 3 June 2026. doi:10.
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