Obesity Clinical Trial
Official title:
The Effects of a Low Energy Diet Versus Low Energy Diet and Intragastric Balloon in Adults With Obesity, All in Combination With Group Treatment: a Randomized, Controlled Trial
In Sweden, approximately 1.3 million adults have obesity. Obesity decreases quality of life
(QoL) and increases the risk of diseases such as type 2-diabetes, non-alcoholic fatty liver
disease (NAFLD), cancer and cardiovascular diseases. Consequently, weight loss improves QoL
and decreases the risk for obesity-related comorbidities.
A treatment combination using a low energy diet (LED) and group treatment based on cognitive
behavioral therapy (CBT), leads to 18 percent weight loss after 6 months. Six months
treatment with an intragastric balloon (IGB) leads to 13 percent weight loss. However, both
treatments are usually followed by weight regain. Combining these treatments has not been
studied before but could lead to better weight maintenance.
The hypothesis is that treatment of adults with obesity, with LED, CBT and IGB, leads to
greater weight loss after 1 year compared to treatment with LED and CBT only.
The study is a randomized, controlled clinical trial, with a 2-year follow-up. One hundred
and ten adults, age 30-65 years, with a BMI of 30-45 kg/m^2 will be included. All
participants will receive 6 months of LED, followed by randomization to either 6 months with
IGB or a control group without IGB. All participants receive CBT-based group treatment during
12 months and followed up after 2 years.
If the treatment combination of LED, CBT and IGB leads to significant weight loss and
improved weight maintenance, increased QoL and reductions of comorbidities and costs of
health care are expected. Effects of treatment on eating behavior, NAFLD, physical activity,
psychological parameters, the gut microbiota, gut permeability and metabolomics will be
assessed.
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