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渐进减肥与快速减肥的有效性 (GoLow)

2026年9月17日 更新者:Jøran Hjelmesæth、The Hospital of Vestfold

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

介入性

注册 (实际的)

293

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Tønsberg、挪威
        • Vestfold Hospital Trust

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

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:

  • • 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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
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
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

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

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
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
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
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
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
Proportions of participants with a TBWL of ≥ 5%, ≥10% and ≥15% at 52-week
大体时间:1-year

TBWL of ≥ 5%, ≥10% and ≥15% at 52-week follow-up

1-year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年4月11日

初级完成 (实际的)

2021年9月16日

研究完成 (实际的)

2021年9月16日

研究注册日期

首次提交

2018年12月12日

首先提交符合 QC 标准的

2018年12月13日

首次发布 (实际的)

2018年12月14日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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