Comparative Effectiveness of a Gradual Weight Loss Program and a Rapid Weight Loss Program (Including a Low Energy Diet) on 1-year Weight Loss in Subjects With Obesity - A Randomized, Parallel-group, Superiority Trial. (The GoLow 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
- 293
- 试验地点
- 1
- 主要终点
- Change in body weight from baseline to 12 months
研究概览
简要总结
This randomized controlled trial aims to compare the 1-year effectiveness of an initial rapid weight loss (RWL) program and a gradual weight loss (GWL) program.
详细描述
A total of at least 286 participants will be randomized to either a 16-week rapid weight loss (RWL) program; [an 8-week low-energy-diet (<1000 kcal/day) - followed by an 8-week gradual increase in energy intake (4 weeks <1300 kcal/day and 4 weeks <1500 kcal/day)], or a 16-week gradual weight loss (GWL) program (controls); [estimated total energy expenditure minus 800-1000 kcal/day]. Thereafter, all participants (both groups) will undergo a 36-week comprehensive weight maintenance program.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessor was masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Willing and able to give informed consent for participation in the study
- •Living in the eastern part of Norway, mainly Oslo, Buskerud, Vestfold and Akershus
- •Understanding Norwegian language written and spoken easily
- •BMI ≥30.0 kg/m2
- •Stable body weight (<5 kg self-reported weight change) during the last 3 months before inclusion
排除标准
- •• Pregnancy and breast-feeding mothers
- •Suspected non-compliance with regards to visits and/or diet
- •Severe chronic disease (endocrine disease, heart disease, neurological disease, lung disease, disease in the gastrointestinal tract, kidney disease, rheumatism or cancer).
结局指标
主要结局
Change in body weight from baseline to 12 months
时间窗: Baseline to 1-year
Percent total body weight loss (%TBWL) at 12 months follow-up
次要结局
- Changes in blood pressure(4-month and 1-year)
- Changes in glucose parameters(4-month and 1-year)
- Changes in lipids(4-month and 1-year)
- Changes in body composition 2(4-month and 1-year)
- Changes in CRP(4-month and 1-year)
- Changes in Health Related Quality of Life 1(4-month and 1-year)
- Changes in Health Related Quality of Life 3(4-month and 1-year)
- Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week(1-year)
- Changes in anthropometric measures(4-month and 1-year)
- Changes in body composition 1(4-month and 1-year)
- Change in weight from baseline to 4 months(4-month)
- Changes in Health Related Quality of Life 2(4-month and 1-year)
- Changes in symptoms of depression and anxiety(4-month and 1-year)
- Changes in eating behavior(4-month and 1-year)
研究者
Jøran Hjelmesæth
Professor, Head
The Hospital of Vestfold