Internet Treatment for Patients With Obesity - a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Obesity-specific quality of life
研究概览
简要总结
There is a strong link between obesity and reduced quality of life as well as serious sequelae of diseases. Step by step is a treatment model that has been developed at the Obesity Unit, Orebro County Region and includes six group meetings over 6-8 months. The aim is to increase patients' knowledge about the disease obesity, to provide support for lifestyle changes and weight control, and to reduce stigma-related psychosocial disorders. A 1-year pilot study aimed at evaluating the Internet-based Step by Step treatment has recently been completed. Results after 6 months of treatment show that the participants who completed the treatment were mainly satisfied with the program and the content. However, the dropouts from the treatment were more than expected.
详细描述
Based on the experience from the pilot study, a new randomized study is planned with the aim of evaluating a revised treatment program. People 25-69 years with a BMI 30-44.9 kg / m2, or with a BMI 28-29.9 kg / m2 and co-occurrence of hypertension, prediabetes, type 2 diabetes, coronary heart disease, hyperlipidemia, hepatic steatosis, sleep apnea or polycystic ovary syndrome can be included. The intervention group receives increased therapist support with physical or digital meetings before and during the treatment as well as individualized feedback from the therapist. Feedback takes place after 6, 12 and 18 weeks. The other group, the control group, implements the program without meetings with the therapist and receives general feedback during the treatment. The purpose is to evaluate whether increased therapist contact compared to less therapist contact leads to improved weight reduction, quality of life, eating habits and increases physical activity at follow-up after 12 months
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
- 25 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 30-44.9 kg / m2
- •BMI 28-29.9 kg / m2 and hypertension
- •BMI 28-29.9 kg / m2 and prediabetes
- •BMI 28-29.9 kg / m2 and type 2 diabetes
- •BMI 28-29.9 kg / m2 and coronary heart disease
- •BMI 28-29.9 kg / m2 and hyperlipidemia
- •BMI 28-29.9 kg / m2 and hepatic steatosis
- •BMI 28-29.9 kg / m2 and sleep apnea
- •BMI 28-29.9 kg / m2 and polycystic ovary syndrome
排除标准
- •Severe mental illness
- •Ongoing or suspected eating disorder
- •Pregnancy
- •Breastfeeding
- •Cancer in active treatment
- •Use of drugs for weight loss
- •Weight loss treatment during the past 6 months
- •Active abuse of alcohol or drugs
- •Not being able to express themselves in Swedish in speech and writing
- •If the study supervisor deems that participation in the study is inappropriate for another reason.
结局指标
主要结局
Obesity-specific quality of life
时间窗: 12 months
Avoidant social behavior due to obesity-related psychosocial disorders which is measured with the Obesity-related Problems scale "(OP)". The OP scale is validated to measure obesity-specific quality of life. OP measures the negative effects of obesity on psychosocial functioning and is useful for evaluating the effects of obesity interventions on quality of life. Scores range from 0 to 100, and higher scores indicate dysfunction.
次要结局
- Proportion of participants with ≥ 5% weight reduction(6 and 12 months)
- Dietary habits(6 and 12 months)
- Weight reduction as a percentage of body weight before treatment(6 and 12 months)
- General health-related quality of life(6 and 12 months)
- Physical activity(6 and 12 months)
- Eating behavior(6 and 12 months)
- Obesity-specific quality of life: psychosocial distress(6 and 12 months)
- Physical activity measured with an accelerometer(During 7 days before treatment and at 6 and 12 months)
- Sleep quality(6 and 12 months)
- Completion of the treatment program(6 and 12 months)
- The participants' experiences and experiences of the treatment(Every three weeks up to 24 weeks)