To Örebro University

AIMS: Low-energy diet (LED) plus cognitive-behavioural therapy (CBT) produces substantial short-term weight loss in obesity, but long-term maintenance remains difficult. We evaluated whether adding intragastric balloon (IGB) treatment to group-based CBT improves weight maintenance after initial weight loss using LED.

MATERIALS AND METHODS: In this open-label randomized controlled trial, adults aged 30-65 years with BMI 32.5-45 kg/m2 underwent a 6-month run-in period combining LED and group-based CBT and were subsequently randomized to CBT and 1-year IGB or CBT alone. The primary endpoint was weight change in percent between randomization (6 months from enrollment) and 18 months (from enrollment), compared to total body weight (TBW) at enrollment. Secondary outcomes included the proportion of participants achieving weight loss thresholds, metabolic parameters and health-related quality of life (HRQoL).

RESULTS: Of 126 enrolled (mean 43.7 years; BMI 38.0 kg/m2), 107 were randomized 6 months after enrollment (IGB n = 51; CBT n = 56) and lost -18.7% (SE: 0.64) of TBW. At 18 months, the mean weight change from randomization was 5.2% with IGB versus 10.1% with CBT (p < 0.001). A significantly greater proportion of IGB recipients achieved ≥ 5% (84.3% vs. 63.6%; p = 0.021) and ≥ 10% (70.6% vs. 45.5%; p = 0.013) weight loss after 18 months, compared to the CBT group. Improvements in metabolic parameters and HRQoL showed no between-group differences.

CONCLUSIONS: 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.