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

Region Örebro County110 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Interventions

Low energy diet using meal replacementsDIETARY_SUPPLEMENT

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.

CBT-based group treatmentBEHAVIORAL

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.

Intragastric balloonDEVICE

An IGB (Orbera IGB, Apollo Endosurgery Inc., Austin, Texas, (CE certified)) is set in place endoscopically by a gastroenterologist at Örebro University Hospital, Region Örebro county, and is left in the stomach for 6 months. A proton-pump inhibitor is prescribed to counteract an increased risk to develop a gastric ulcer. During the first 2 weeks, dietary adjustments are necessary to adapt to the IGB. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended identical to the control group. The IGB is removed endoscopically after 6 months IGB treatment.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Weight loss in percent of total body weight

Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.

Time frame: Change from baseline at 12 months

Secondary Outcomes

Weight loss in percent of total body weight

Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.

Time frame: Change from baseline at 6 months

Weight loss in percent of total body weight at 2-year follow-up

Two years after treatment start and thus one year after completion of the intervention, participants will be followed up on total body weight. Weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.

Time frame: Change from baseline at 24 months

The proportion of participants with ≥5 percent reduction of total body weight from baseline

Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.

Time frame: 6, 12 and 24 months

The proportion of participants with ≥10 percent reduction of total body weight from baseline

Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.

Time frame: 6, 12 and 24 months

The proportion of participants with ≥15 percent reduction of total body weight from baseline

Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.

Time frame: 6, 12 and 24 months

Effect of treatment on bioelectrical impedance measurement to assess fat mass

Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Fatt mass is estimated and results are presented in kilograms.

Time frame: Change from baseline at 6, 12 and 24 months

Effect of treatment on bioelectrical impedance measurement to assess muscle mass

Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Muscle mass is estimated and results are presented in kilograms.

Time frame: Change from baseline at 6, 12 and 24 months

Change in waist circumference

Waist circumference is measured in centimeters according to the World Health Organization protocol.

Time frame: Change from baseline at 6, 12 and 24 months

Change in 2-hour oral glucose tolerance test

Effect on the 2-hour oral glucose tolerance test (OGTT) is measured by analysing glucose (mmol/L) in a fasting blood sample. Thereafter the participant drinks a standardized amount of glucose. After 120 minutes, a blood sample is analyzed again for glucose (mmol/L) .