Intragastric balloon as an adjunct to lifestyle intervention: A randomized controlled trial

A. Courcoulas, B. K. Abu Dayyeh, L. Eaton, J. Robinson, G. Woodman, M. Fusco, V. Shayani, H. Billy, D. Pambianco, C. Gostout

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

Background/objectives:This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.Subjects/methods:In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg m - 2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss.Results:At 6 months, weight loss was -3.3% of total body weight (-3.2 kg) in the lifestyle arm vs -10.2% (-9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was -3.4% (-3.2 kg) vs -9.1% (-8.8 kg, P≤0.001); and at 12 months, -3.1% (-2.9 kg) vs -7.6% (-7.4 kg, P≤0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found.Conclusions and relevance:Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.

Original languageEnglish (US)
Pages (from-to)427-433
Number of pages7
JournalInternational Journal of Obesity
Volume41
Issue number3
DOIs
StatePublished - Mar 1 2017

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Life Style
Randomized Controlled Trials
Weight Loss
Ideal Body Weight
Device Removal
Control Groups
Nausea
Abdominal Pain
Ulcer
Vomiting
Stomach
Body Mass Index
Body Weight
Clinical Trials
Safety
Equipment and Supplies

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Endocrinology, Diabetes and Metabolism
  • Nutrition and Dietetics

Cite this

Courcoulas, A., Abu Dayyeh, B. K., Eaton, L., Robinson, J., Woodman, G., Fusco, M., ... Gostout, C. (2017). Intragastric balloon as an adjunct to lifestyle intervention: A randomized controlled trial. International Journal of Obesity, 41(3), 427-433. https://doi.org/10.1038/ijo.2016.229

Intragastric balloon as an adjunct to lifestyle intervention : A randomized controlled trial. / Courcoulas, A.; Abu Dayyeh, B. K.; Eaton, L.; Robinson, J.; Woodman, G.; Fusco, M.; Shayani, V.; Billy, H.; Pambianco, D.; Gostout, C.

In: International Journal of Obesity, Vol. 41, No. 3, 01.03.2017, p. 427-433.

Research output: Contribution to journalArticle

Courcoulas, A, Abu Dayyeh, BK, Eaton, L, Robinson, J, Woodman, G, Fusco, M, Shayani, V, Billy, H, Pambianco, D & Gostout, C 2017, 'Intragastric balloon as an adjunct to lifestyle intervention: A randomized controlled trial', International Journal of Obesity, vol. 41, no. 3, pp. 427-433. https://doi.org/10.1038/ijo.2016.229
Courcoulas A, Abu Dayyeh BK, Eaton L, Robinson J, Woodman G, Fusco M et al. Intragastric balloon as an adjunct to lifestyle intervention: A randomized controlled trial. International Journal of Obesity. 2017 Mar 1;41(3):427-433. https://doi.org/10.1038/ijo.2016.229
Courcoulas, A. ; Abu Dayyeh, B. K. ; Eaton, L. ; Robinson, J. ; Woodman, G. ; Fusco, M. ; Shayani, V. ; Billy, H. ; Pambianco, D. ; Gostout, C. / Intragastric balloon as an adjunct to lifestyle intervention : A randomized controlled trial. In: International Journal of Obesity. 2017 ; Vol. 41, No. 3. pp. 427-433.
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AU - Robinson, J.

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AU - Fusco, M.

AU - Shayani, V.

AU - Billy, H.

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N2 - Background/objectives:This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.Subjects/methods:In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg m - 2 were treated and outcomes were assessed up to 12 months. Participants were randomized to endoscopic placement of an intragastric balloon plus lifestyle or lifestyle intervention alone. Balloons were removed at 6 months and lifestyle intervention continued for both groups through 12 months. At 9 months, coprimary end points were two measures of weight loss.Results:At 6 months, weight loss was -3.3% of total body weight (-3.2 kg) in the lifestyle arm vs -10.2% (-9.9 kg) in the balloon plus lifestyle arm (P<0.001); at 9 months (3 months postballoon removal), weight loss was -3.4% (-3.2 kg) vs -9.1% (-8.8 kg, P≤0.001); and at 12 months, -3.1% (-2.9 kg) vs -7.6% (-7.4 kg, P≤0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P<0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found.Conclusions and relevance:Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common.

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