渐进减肥与快速减肥的有效性 (GoLow)
渐进减肥计划和快速减肥计划(包括低能量饮食)对肥胖受试者 1 年减肥效果的比较 - 一项随机、平行组、优效性试验。 (GoLow 研究)。
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Tønsberg、挪威
- Vestfold Hospital Trust
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
-
• 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
Exclusion Criteria:
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• 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).
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器: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. |
16-week rapid weight loss (RWL) program (8-week low energy diet (LED) followed by 8-week gradual increased energy intake) and a subsequent 36-week weight-maintenance follow-up |
|
有源比较器: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. |
16-week gradual weight loss (GWL) program (moderate calorie restriction) and a subsequent 36-week weight-maintenance follow-up |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in body weight from baseline to 12 months
大体时间:Baseline to 1-year
|
Percent total body weight loss (%TBWL) at 12 months follow-up |
Baseline to 1-year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in anthropometric measures
大体时间:4-month and 1-year
|
Waist and hip circumference (cm) |
4-month and 1-year
|
|
Changes in body composition 1
大体时间:4-month and 1-year
|
Bioelectrical Impedance Analysis (BIA) |
4-month and 1-year
|
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Changes in body composition 2
大体时间:4-month and 1-year
|
Dual-energy X-ray Absorptiometry (DXA) in selected participants |
4-month and 1-year
|
|
Changes in lipids
大体时间:4-month and 1-year
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Total-cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides (mmol/l) |
4-month and 1-year
|
|
Changes in blood pressure
大体时间:4-month and 1-year
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Systolic and diastolic blood pressure (mm/Hg) |
4-month and 1-year
|
|
Changes in glucose parameters
大体时间:4-month and 1-year
|
HbA1c (mmol/mol) |
4-month and 1-year
|
|
Changes in CRP
大体时间:4-month and 1-year
|
CRP (mg/L) |
4-month and 1-year
|
|
Changes in Health Related Quality of Life 1
大体时间:4-month and 1-year
|
Generic questionnaire: Short Form-36 Health Survey, SF36. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores for each of the 8 domains and summary scores for physical and mental health will be calculated |
4-month and 1-year
|
|
Changes in Health Related Quality of Life 2
大体时间:4-month and 1-year
|
Obesity specific questionnaire: IWQOL-lite. The IWQOL-Lite is a 31-item measure of weight-related quality of life. There are five domain scores (Physical Function, Self-Esteem, Sexual Life, Public Distress and Work) and a total score. Scores for all domains and total score range from 0-100, with lower scores indicating greater impairment. |
4-month and 1-year
|
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Changes in Health Related Quality of Life 3
大体时间:4-month and 1-year
|
Weight-related Symptom Measure (WRSM). The validated obesity specific WRSM measures 20 symptoms commonly related to being overweight or obese, including foot problems, joint pain, sensitivity to cold, shortness of breath, etc. using two different sets of items. The first set assesses whether or not a patient is experiencing specific symptoms, and the second set rates the level of the distress of the symptoms with values from zero ("not at all") to six ("bothers a very great deal"). The first set creates an additive scale summing symptoms from 0-20, while the second forms a symptom distress scale ranging from 0-120. |
4-month and 1-year
|
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Changes in symptoms of depression and anxiety
大体时间:4-month and 1-year
|
Hospital Anxiety and Depression Scale (HADS). The validated generic HADS measures symptoms of anxiety and depression using 14 items scored from 0-3 It is decomposed into two domains measuring depression (HADS-D) and anxiety (HADS-A), both consisting of seven items yielding a score from 0-21. |
4-month and 1-year
|
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Changes in eating behavior
大体时间:4-month and 1-year
|
The Three Factor Eating Questionnaire -R 21 (TFEQ-R21) measures eating behaviour and has been validated for use in individuals with obesity and will be used in the study. It consists of 21 items comprising three domain scores; (1) uncontrolled eating; assessing the tendency to lose control over eating when feeling hungry or when exposed to external stimuli, (2) cognitive restraint; assessing the conscious restriction of food intake to control body weight or body shape, and (3) emotional eating; assessing overeating related to negative mood states. The domain scores were transformed to 0-100 scales to facilitate comparison; a higher score indicates more uncontrolled, restraint, or emotional eating. |
4-month and 1-year
|
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Change in weight from baseline to 4 months
大体时间:4-month
|
Percent total body weight loss (%TBWL) at 4 months follow-up |
4-month
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Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
大体时间:1-year
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TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up |
1-year
|
合作者和调查者
合作者
调查人员
- 首席研究员:Jøran Hjelmesæth, Professor、The Hospital of Vestfold
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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