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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Weight loss in percent of total body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 30 and ≤45 kg/m^2
- •Age 30 to 65 years
排除标准
- •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)
研究组 & 干预措施
Control group
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.
干预措施: Low energy diet using meal replacements (Dietary Supplement)
Control group
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.
干预措施: CBT-based group treatment (Behavioral)
IGB group
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.
干预措施: Low energy diet using meal replacements (Dietary Supplement)
IGB group
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.
干预措施: CBT-based group treatment (Behavioral)
IGB group
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.
干预措施: Intragastric balloon (Device)
结局指标
主要结局
Weight loss in percent of total body weight
时间窗: Change from baseline at 12 months
Total body weight is measured in light indoor clothing without shoes on a calibrated bio-impedance scale.
次要结局
- Weight loss in percent of total body weight(Change from baseline at 6 months)
- The proportion of participants with ≥5 percent reduction of total body weight from baseline(6, 12 and 24 months)
- Change in waist circumference(Change from baseline at 6, 12 and 24 months)
- Change in 2-hour oral glucose tolerance test(Change from baseline at 6 and 12 months)
- Change in insulin(Change from baseline at 6 and 12 months)
- Change in kidney function(Change from baseline at 6 and 12 months)
- Change in liver transaminases(Change from baseline at 6 and 12 months)
- 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)
- Weight loss in percent of total body weight at 2-year follow-up(Change from baseline at 24 months)
- Effect of treatment on bioelectrical impedance measurement to assess muscle mass(Change from baseline at 6, 12 and 24 months)
- Change in blood pressure(Change from baseline at 6 and 12 months)
- 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)
- Effect of treatment on RAND-36 (SF-36) to measure QoL(Change from baseline at 6, 12 and 24 months)
- The proportion of participants with ≥10 percent reduction of total body weight from baseline(6, 12 and 24 months)
- Change in Hemoglobin A1c(Change from baseline at 6 and 12 months)
- Change in Homeostatic Model Assessment of Insulin Resistance(Change from baseline at 6 and 12 months)
- Change in thrombocytes(Change from baseline at 6 and 12 months)
- 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)
- 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)
- Calculation of cost-effectiveness of treatment using multi-variable analysis(Change from baseline at 6, 12 and 24 months)
- The proportion of participants with ≥15 percent reduction of total body weight from baseline(6, 12 and 24 months)
- Effect of treatment on bioelectrical impedance measurement to assess fat mass(Change from baseline at 6, 12 and 24 months)
- Change in serum lipids(Change from baseline at 6 and 12 months)
- Effects of treatment on hunger and satiety(Change from baseline at 4, 12, 20, 24, 28, 36, 44, 52 and 104 weeks)
- Effect of treatment on 7-day step count to measure physical activity(Change from baseline at 6, 12 and 24 months)
- Effect of treatment on sitting time and physical activity(Change from baseline at 6, 12 and 24 months)
- Effect of treatment on the use of medication for glucose lowering treatment, hypertension and hyperlipidemia(Change from baseline at 6, 12 and 24 months)