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

NCT04230655 | Unknown FDA Device

• 1 other identifier: 256841
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Weight Loss; Non-Alcoholic Fatty Liver Disease

Keywords

Obesity; Weight loss; Low energy diet; Intragastric balloon; Group treatment; Non-alcoholic fatty liver disease; Quality of life; Body weight; Glucose metabolism; Eating behavior; Microbiomics; Physical activity; Gastrointestinal symptoms; Psychological parameters

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline at 12 months

Secondary Outcomes (27)

• Weight loss in percent of total body weight

  Change from baseline at 6 months

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

  Change from baseline at 24 months

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

  6, 12 and 24 months

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

  6, 12 and 24 months

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

  6, 12 and 24 months

Other Outcomes (33)

• Comparison of the calculated risk for liver fibrosis using the fibrosis-4 (FIB-4) calculation to prevalence of liver fibrosis in the study population detected by vibration-controlled transient elastography

  At baseline, 6 and 12

• Effect of treatment on lipidomics

  Change from baseline at 6 and 12 months

• Change in gut microbiota compositions during treatment with LED, re-introduction of the recommended diet and treatment with IGB

  Change from baseline at 2, 4, 6, 9 and 12 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

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

IGB group

EXPERIMENTAL

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.

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

Interventions

Low energy diet using meal replacements DIETARY_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.

Also known as: LED

Control group; IGB group

CBT-based group treatment BEHAVIORAL

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.

Also known as: CBT

Control group; IGB group

Intragastric balloon DEVICE

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.

Also known as: IGB

IGB group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Medicinmottagning 5/Överviktsenheten, University Hospital Örebro

Örebro, 70185, Sweden

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss; Non-alcoholic Fatty Liver Disease; Body Weight; Feeding Behavior; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Fatty Liver; Liver Diseases; Digestive System Diseases; Behavior, Animal; Behavior

Study Officials

• Johan Jendle, Professor

  johan.jendle@oru.se

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marije Galavazi, PhD, MD

CONTACT

+46196026631; marije.galavazi@regionorebrolan.se

Johan Jendle, Professor

CONTACT

+46709571257; johan.jendle@oru.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is an open labelled, randomized, controlled clinical trial, with a ratio 1:1.

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 18, 2020
• Study Start: December 10, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)