Weight Loss in Adults With Obesity Using a Combination of Low Energy Diet, Group Treatment and Intragastric Balloon

Region Örebro County

Status: Unknown

Conditions: Weight Loss; Obesity; Non-Alcoholic Fatty Liver Disease

Treatments: Behavioral: CBT-based group treatment; Device: Intragastric balloon; Dietary Supplement: Low energy diet using meal replacements

Study type: Interventional

Funder types: Other

Identifiers

NCT04230655

256841

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥ 30 and ≤45 kg/m^2
• Age 30 to 65 years

Exclusion criteria

• Participation in an organized weight reduction programme or pharmacological treatment for weight loss within the last 3 months
• Daily use of meal replacement products within the last 3 months
• Previous gastric surgery
• Current gastric, duodenal or oesophageal ulcers
• Inflammatory disease of the gastrointestinal tract including oesophagitis, or specific inflammation such as Crohn's disease
• Known potential upper gastrointestinal bleeding conditions such as gastric or oesophageal varices
• Known structural abnormalities of the pharynx or oesophagus
• Symptoms suggestive for severe gastric motility disorder
• Known hiatus hernia ≥ 5 cm
• Cancer diagnosed within the last 5 years or ongoing treatment for cancer (except non-metastasising skin cancer)
• Known severe heart failure (NYHA 3-4)
• Known chronic obstructive pulmonary disease (FEV1 ≤ 50 percent)
• Kidney failure (eGFR ≤ 30 ml/min)
• Liver failure (liver enzymes more than 3 times the normal threshold)
• Known proliferative retinopathy
• Known or suspected abuse of alcohol or narcotics
• Current or history of systemic treatment with corticosteroids within the last 3 months
• Known myocardial infarction or stroke within the last 6 months
• Current or history of pancreatitis
• Pregnancy, intention to become pregnant or breastfeeding during the study
• Untreated or insufficient treated hypo- or hyperthyroidism
• Current use of anticoagulants: warfarin, apixaban, dabigatran, edoxaban and rivaroxaban
• Current use of thrombocyte aggregation inhibitors: clopidogrel and acetylsalicylic acid
• Known or previous eating disorder
• Antimicrobial treatment within 3 months prior to study may lead to postponed participation
• Regular consumption of probiotic capsules within 1 month prior to study start may lead to postponed participation
• Participants considered to be unsuitable for the study by the investigator (e.g. serious psychiatric disorders, suspected eating disorders)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Control group

Active Comparator group

Description:

All participants in the control group are treated with LED and CBT-based group treatment as described below. All participants (control and intervention) receive 2.5-hour sessions of CBT-based group treatment every 4 weeks for 1 year. Participants are randomly assigned to groups of 8-16 participants. Two groups of about the same size start simultaneously. The LED phase (from baseline to 24 weeks) consists of 12 weeks with 4 portions/day of liquid meal replacements, for a total of 800-880 kcal/day, followed by a 12-week slow phasing out to a regular diet. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended.

Treatment:

Dietary Supplement: Low energy diet using meal replacements

Behavioral: CBT-based group treatment

IGB group

Experimental group

Description:

All participants in the IGB group are treated with LED and CBT-based group treatment as described for the control group. Participants in the intervention group are treated with an IGB for 6 months from 6 months from start.

Treatment:

Dietary Supplement: Low energy diet using meal replacements

Device: Intragastric balloon

Behavioral: CBT-based group treatment