Obesity Treatment With LCD(Low Calorie Diet) in Primary Health Care - Long Term Effects With or Without Internet Based CBT (Cognitive Behavioral Therapy) , for Weight Stability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- • Weight reduction in kg and % from baseline to 1 and 2 years
研究概览
简要总结
The aim of this study is to evaluate if an internet-based CBT (Cognitive Behavioral Therapy) programme for weight stability after LCD (Low Calorie diet) treatment for obesity, can reduce weight gain and improve weight stability, self reported health, pain, eating behavior, fatigue and mood.
Adults with obesity and health problems in primary health care are invited to be part of the study. The geographical area is Orebro county which has in all 29 primary health care centers. Population is 276 000, and according to population studies around 15% of the adult population has a BodyMassIndex (BMI) over 30, which is characterized as obesity according to WHO.
Specific objectives are;
- To evaluate if internet-based CBT treatment after LCD improves weight stability after 1 and 2 years.
- To evaluate if weight loss improves metabolic parameters such as HbA1c, blood glucose, Cholesterol, Low density lipoproteins (LDL),High density lipoproteins (HDL) , triglycerides (TG) and Bloodpressure (BP)
- To evaluate weight loss influence on quality of life, body pain, eating behavior, obesity related problems, fatigue and mood, and to see if CBT program for weight stability also improves these factors
- To evaluate if LCD treatment is a possible treatment for obesity in ordinary primary health care
Patients taking part in the study, undergo a 12 week period of Low Calorie Diet (LCD) treatment, followed by a 12 week reintroduction to ordinary food. During this period the patient has contact with the primary health care nurse and doctor. After 24 weeks of treatment, the patient who follows the study is supposed to have lost around 10% of initial weight.All patients losing more than 7% weight during the first 24 weeks, are randomized to either ordinary follow up (group 1) or an internet-based CBT programme for weight stability (group 2). All patients in the study are followed at 1 year by doctor, and at 2 year by nurse visit.
详细描述
Patients are recruited in an ordinary primary care setting in Primary care centers in Orebro County. All Primary care centers in the area (26) are invited to take part in the study.
Patients are given brief information at ordinary visits at doctor, nurse or physiotherapists, or by written information announced at the health care center. Before going into the study they need a doctors visit to pass the inclusion and exclusion criteria. The study starts at a nurse visit where the patient gets written information about the LCD treatment and the protocol.
After 24 weeks in the study, all patients with weight loss of 7% or more are randomized into two groups.
Group 1, keep their contact with the nurse at the primary health care centre, and gets a written prescription of physical activity, which is followed by a visit at 36 weeks.
Group 2, gets a code for the internet-based CBT programme. They go into the programme at home, and follow the programme which has the goal of weight stability and contains strategies of meal plans, portion controls, physical activity planning, and cognitive strategies of thinking and goal setting. During this programme there is an opportunity to "chat" with CBT therapists via the internet, concerning the programme and its challenges. No personal meeting with therapist is included.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 30 with health problems and willingness and motivation to make lifestyle changes.
- •Access to the internet and the ability to read and understand written information in swedish.
排除标准
- •BMI < 30
- •Excessive eating disorder problems (screening forms are used)
- •Severe heart failure (New York Heart Association (NYHA) class III-IV)
- •Moderate or severe COPD (Chronic Obstructive Pulmonary Disease) (FEV% <50)
- •Uncontrolled asthma (hospitalization or more than twice requiring inhalation treatment on health care site last year)
- •Pregnancy and lactation
- •Type 1 Diabetes
- •Serious liver dysfunction (ALT value more than doubled, women> 1.5 μkat / L, men> 2.2 μkat / L)
- •Former Gastric bypass surgery or other weight reducing surgery
研究组 & 干预措施
Ordinary primary care follow up
Ordinary follow up after 24 weeks of LCD diet + reintroduction of food.
CBT follow up
11 weeks intervention programme with CBT conducted via internet.
干预措施: CBT follow up (Behavioral)
结局指标
主要结局
• Weight reduction in kg and % from baseline to 1 and 2 years
时间窗: Change from baseline to follow up at 1 and 2 years
Patients in the intervention group (Group 2) have an average of 5 kg greater weight loss at 1 year follow-up compared with patients in the control group (Group 1) Out of patients completing 1 year of treatment, 75% reached the weight loss -5%, and 50% have achieved weight loss - 10%
次要结局
- • LCD treatment is an effective and suitable treatment for primary health care(Change from baseline to follow up at 1 and 2 years)
- Quality of life improvements in both groups compared with baseline at one year(baseline to 1 year)
- Improved metabolic control (lower weight and waist circumference, lower TGA) Higher HDL, lower Hba1c(From baseline to 1 year)
研究者
Jan Karlsson
Behaviorist
Örebro County Council