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

Not Applicable

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

• Registration Number: NCT04230655
• Lead Sponsor: Region Örebro County

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2019-12-30
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-14
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Weight loss in percent of total body weight	Change from baseline at 12 months	Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.

Secondary Outcome Measures

Name	Time	Method
Change in waist circumference	Change from baseline at 6, 12 and 24 months	Waist circumference is measured in centimeters according to the World Health Organization protocol.
Change in 2-hour oral glucose tolerance test	Change from baseline at 6 and 12 months	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) .
Change in insulin	Change from baseline at 6 and 12 months	Insulin is analyzed in a fasting blood sample and presented in mIE/L.
Change in kidney function	Change from baseline at 6 and 12 months	Kidney function is assessed by analysing blood samples for creatinine (µmol/L). The result is used to calculate the estimated glomerular filtration rate (eGFR) using the Lund-Malmö revised calculation. eGFR is presented as mL/min/1,73m\^2.
Change in liver transaminases	Change from baseline at 6 and 12 months	Liver transaminases are measured by analysing alanine transaminase (ALT) and aspartate transaminase (AST) in a fasting blood sample. Data is presented in µkat/L.
Effects of treatment on the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18V2) items to measure eating behavior	Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks	The TFEQ-R18V2 is a validated questionnaire to measure three aspects of eating behavior: uncontrolled eating (9 items), cognitive restraint (3 items), and emotional eating (6 items).
Weight loss in percent of total body weight at 2-year follow-up	Change from baseline at 24 months	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.
Effect of treatment on bioelectrical impedance measurement to assess muscle mass	Change from baseline at 6, 12 and 24 months	Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Muscle mass is estimated and results are presented in kilograms.
Change in blood pressure	Change from baseline at 6 and 12 months	Blood pressure is measured using a correct cuff size for the circumference of participant's arm after 5 minutes rest in a sitting position.
Effect of treatment on vibration-controlled transient elastography measurement to assess level of liver steatosis and fibrosis	Change from baseline at 6 and 12 months	Evaluation of NAFLD at baseline and effect of treatment using vibration-controlled transient elastography to detect liver stiffness (in kPa) and determine the steatosis and fibrosis score (0 to 4 there 0 means no steatosis or fibrosis).
Effect of treatment on RAND-36 (SF-36) to measure QoL	Change from baseline at 6, 12 and 24 months	RAND-36 (SF-36) questionnaire is validated to measure QoL and comprises 36 items measuring eight domains that reflect a wide spectrum of physical and mental health aspects: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health.
The proportion of participants with ≥10 percent reduction of total body weight from baseline	6, 12 and 24 months	Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Change in Hemoglobin A1c	Change from baseline at 6 and 12 months	Hemoglobin A1c (HbA1c) in mmol/L is analyzed in a fasting blood sample.
Change in Homeostatic Model Assessment of Insulin Resistance	Change from baseline at 6 and 12 months	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is calculated using fasting values of insulin and glucose.
Change in thrombocytes	Change from baseline at 6 and 12 months	Thrombocytes are analyzed in a fasting blood sample and presented as 10\*9/L.
Effect of treatment on the Obesity-related Problems scale, version 3 (OPv3) to measure weight-related psychosocial functioning	Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks	OPv3 is validated to measure obesity-specific quality of life with 26 items. OP measures the negative effects of obesity on psychosocial functioning.
The effect of treatment on the use of health care and absence from work during treatment	Change from baseline at 6, 12 and 24 months	Health care utilization and absence from work are measured with self-assessment questionnaires. A patient record survey is performed at 12 and 24 months.
Calculation of cost-effectiveness of treatment using multi-variable analysis	Change from baseline at 6, 12 and 24 months	Cost-effectiveness is analyzed using data on health care utilization, absence from work, use of medication and QoL questionnaires (RAND-36 and OPv3). Data is combined and analyzed together to calculate and report cost-effectiveness. All used measurements are also described above as separate secondary outcome measures.
The proportion of participants with ≥15 percent reduction of total body weight from baseline	6, 12 and 24 months	Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
Effect of treatment on bioelectrical impedance measurement to assess fat mass	Change from baseline at 6, 12 and 24 months	Bioelectrical impedance analysis is performed with a Body Composition Analyzer BC-420MA. Fatt mass is estimated and results are presented in kilograms.
Change in serum lipids	Change from baseline at 6 and 12 months	Total cholesterol, HDL, LDL and triglycerides are analyzed in a fasting blood sample. Results are presented in mmol/L.
Effects of treatment on hunger and satiety	Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks	Hunger and satiety are assessed by a questionnaire with 9 single items on a 5-point Likert scale.
Effect of treatment on 7-day step count to measure physical activity	Change from baseline at 6, 12 and 24 months	Step count is measured during 7 consecutive days using an accelerometer. The data is completed with questions on water-based activities and cycling on these days.
Effect of treatment on sitting time and physical activity	Change from baseline at 6, 12 and 24 months	Self-reported data on physical activity will be measured by a validated questionnaire from the National Board of Health and Welfare, Sweden, concerning sitting time and hours of light and moderate activity.
Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia	Change from baseline at 6, 12 and 24 months	Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia is assessed by asking participants at every study contact, if changes in medication have been made. A patient record survey for prescribed medication is performed at 12 and 24 months.
Weight loss in percent of total body weight	Change from baseline at 6 months	Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
The proportion of participants with ≥5 percent reduction of total body weight from baseline	6, 12 and 24 months	Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.

Trial Locations

Locations (1)

Medicinmottagning 5/Överviktsenheten, University Hospital Örebro; 🇸🇪 Örebro, Sweden