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
- 已完成
- 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).
研究组 & 干预措施
Rapid weight loss (RWL) program
16-week rapid weight loss (RWL) program [8-week LED (<1000 kcal/day) - followed by an 8-week gradual increase in energy intake (4 weeks <1300 kcal/day and 4 weeks <1500 kcal/day)] followed by a 36-weight loss maintenance program.
干预措施: Rapid weight loss (RWL) program (Other)
Gradual weight loss (GWL) program
16-week GWL-program (estimated total energy expenditure minus 800-1000 kcal/day) followed by a 36-weight loss maintenance program.
干预措施: Gradual weight loss (GWL) program (Other)
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 glucose parameters(4-month and 1-year)
- Changes in blood pressure(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