The Effect of a Multi-component Weight Management Program on Appetite, Food Preference and Body Weight (SWSS)
2017年5月31日 更新者：Dr Graham Finlayson、University of Leeds
The aim of the current study is to demonstrate that a commercial weight management diet (i.e. low energy density) influences satiation, hunger and satiety and leads to lower energy intake during ad-libitum meals and over a full day. We further seek to demonstrate the sustainability of this effect following 12- week weight loss on the weight management program.
- We hypothesise that formulated (low energy) meals will lead to decreased hunger, greater fullness and reduced desire to eat compared to standard meals.
- We hypothesise that the commercial weight management program will lead to greater weight loss compared to control program.
- We hypothesise that formulated meals (high consumer acceptance) will improve hedonic control over eating (lower wanting for high fat food)
- We hypothesise that the commercial weight management program will improve hedonic control over eating (reduced experience food cravings)
研究概览
研究类型
介入性
注册 (实际的)
96
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
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West Yorkshire
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Leeds、West Yorkshire、英国、LS2 9JT
- University of Leeds
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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 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- BMI of 28 - 45 kg/m2
- Reporting an interest in weight loss, not actively participating in a commercial weight loss program,
- Not increased physical activity levels in the past 2-4 weeks
- Able to eat most everyday foods and fruits and vegetables
- Written informed consent to be given
Exclusion Criteria:
- Significant health problems that could cause confounding effects between intervention and control.
- Taking any medication or supplements known to affect appetite or weight within the past month and/or during the study
- Pregnant, planning to become pregnant or breastfeeding
- History of anaphylaxis to food
- Known food allergies or food intolerance
- Smokers and those who have recently ceased smoking
- Participants receiving systemic or local treatment likely to interfere with evaluation of the study parameters
- Those who have previously taken part in a commercial weight loss program in the last 6 months? .
- Participants who work in appetite or feeding related areas
- Participants unable to consume foods used in the study
- Participants who have had bariatric surgery
- Participants with a history of eating disorder
- Presence of untreated hypothyroidism
- Inability to fully comply with intervention or study procedures
- Insufficient English language skills to complete study questionnaires
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：基础科学
- 分配：非随机化
- 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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实验性的：Intervention Group
Participants enrolled in commercial weight management program
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有源比较器：Control group
Participants enrolled in standard care weight management provision
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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 |
|---|---|---|
|
Test Meal Energy Intake
大体时间：Week 0 and week 12
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Measured reductions in ad-libitum energy intake following consumption of formulated test meal in comparison to control.
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Week 0 and week 12
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24h Energy Intake
大体时间：Week 0 and week 12
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Measured reduction in total within-day energy intake following consumption of formulated meals in comparison to control
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Week 0 and week 12
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Appetite sensations
大体时间：Week 0 and week 14
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Measured reduction in hunger and increase in satiety quotient following consumption of formulated test meal in comparison to equi-energetic control
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Week 0 and week 14
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Food preference
大体时间：Week 0 and week 14
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Measured changes in food preference and liking and wanting profiles for food (HF<LF) following consumption of formulated test meal in comparison to equi-energetic control
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Week 0 and week 14
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Weight
大体时间：Weekly from week 0 to week 12
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Measured change in weight and energy balance parameters over a 12 week period following participation in commercial weight management program compared to control group.
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Weekly from week 0 to week 12
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Food diary
大体时间：Week 0 and week 12
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Intervention adherence and compensation through 1) food diary analysis.
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Week 0 and week 12
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Accelerometer
大体时间：Week 0 and week 12
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Intervention adherence and compensation through accelerometer analysis.
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Week 0 and week 12
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Interview
大体时间：Week 12
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Detailed feedback on participant experience of commercial weight management program through qualitative interview and marketing survey.
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Week 12
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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。
调查人员
- 首席研究员：Graham S Finlayson, PhD、University of Leeds
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Buckland NJ, Camidge D, Croden F, Myers A, Lavin JH, Stubbs RJ, Blundell JE, Finlayson G. Women with a low-satiety phenotype show impaired appetite control and greater resistance to weight loss. Br J Nutr. 2019 Oct 28;122(8):951-959. doi: 10.1017/S000711451900179X.
- Buckland NJ, Camidge D, Croden F, Lavin JH, Stubbs RJ, Hetherington MM, Blundell JE, Finlayson G. A Low Energy-Dense Diet in the Context of a Weight-Management Program Affects Appetite Control in Overweight and Obese Women. J Nutr. 2018 May 1;148(5):798-806. doi: 10.1093/jn/nxy041.
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
2014年1月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2016年5月1日
研究注册日期
首次提交
2013年12月10日
首先提交符合 QC 标准的
2013年12月10日
首次发布 (估计)
2013年12月16日
研究记录更新
最后更新发布 (实际的)
2017年6月1日
上次提交的符合 QC 标准的更新
2017年5月31日
最后验证
2017年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Weight management program的临床试验
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University of ManchesterNational Secretariat of Science, Technology and Innovation in Panama (SENACYT)完全的
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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The University of Hong KongSydney Children's Hospitals Network; SAHK招聘中