Placebo-Controlled, Randomized Weight Loss InterventionTrial in Subjects With Overweight or Obesity in Primary Health Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change of weight between intervention group and placebo
研究概览
简要总结
This study evaluates weight loss effect of the method LEVA by Bertz et al in subjects with overweight or obesity that are remitted to Primärvårdens Dietistenhet.
详细描述
The method "Lifestyle at Effective Weight Loss During Breastfeeding" (LEVA method by Bertz et al) has been scientifically studied to provide sustainable weight loss for women with overweight or obesity after childbirth. Primary health care centers in Västra Götalandsregionen treat adult patients with overweight and obesity. If the LEVA method by Bertz et el also produces weight loss to other patient groups than women post partum, the method could be used as a treatment alternative.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 27 ≤ 35
- •age 18-75 år
排除标准
- •difficulty understanding Swedish, spoken or read
- •does not manage/want to handle digital Tools
- •the remittance was addressed to Primärvårdens Dietistenhet at wrong premises and the patient should be treated elsewhere.
结局指标
主要结局
Change of weight between intervention group and placebo
时间窗: From baseline and 2 year
Weight in kg measured at visits
次要结局
- Cost-effectiveness of LEVA method by Bertz et al(From baseline to 2 year)
- Gender differences in weight loss results(From baseline to 2 year)
- Age differences in weight loss results(From baseline to 2 years)
- Weight loss result in relation to pre-treatment BMI(From baseline to 2 year)