基于失调的肥胖预防计划的有效性试验 (Project Health)
2018年9月19日 更新者：Oregon Research Institute
肥胖是美国的一个主要公共卫生问题。
很少有肥胖预防计划降低了随访期间体重增加的风险，而且那些计划非常密集，这使得传播变得困难且成本高昂。
一个简短的 3 小时选择性预防计划（健康体重），针对身体不满意的年轻人，涉及参与者驱动的健康饮食和身体活动生活方式的改变，相对于替代干预和仅评估，显着减少了体重指数 (BMI) 和肥胖发作的增加通过 3 年的随访进行控制，尽管影响幅度很小。
为了提高疗效，研究人员增加了关于不健康饮食和活动习惯的失调诱导活动，借鉴了基于失调的高效饮食失调预防计划。
一项试点试验发现，相对于健康体重干预和教育手册条件，这项新的项目健康干预显着降低了 BMI 从前到后的增加。
研究人员建议进行一项严格的多站点有效性试验，以测试将失调诱导元素添加到最初的健康体重干预措施中是否会提高预防体重增加的效果。
360 名因年龄和体重问题而面临未来体重风险的大学生将被随机分配到以下三种情况之一：(1) 一个改进的 6 小时小组基于不协调的项目健康，(2) 一个 6 小时小组-基于健康体重干预，或 (3) 心理教育视频（“世界的重量”）条件。
参与者将在前、后、6、12 和 24 个月的随访中完成对体脂百分比、调节剂（包括客观测量的身体活动）、调节剂和其他结果的评估。
研究概览
详细说明
目标 1 将检验这样一个假设，即在 2 年的随访期间，相对于健康体重干预和视频控制条件，Project Health 显着减少了身体脂肪百分比的增加；次要结果是 BMI、抑郁症状和进食障碍症状。 研究人员还将“健康体重”与视频控制进行比较。
目标 2 将检验以下假设：Project Health 参与者在吃不健康的食物和久坐不动的行为方面会经历更多的认知失调（一种不舒服的心理状态），并且失调的变化会调节该项目的体重增加预防效果。 研究人员还将测试减少卡路里摄入量和增加身体活动是否会调节 Project Health 对身体脂肪百分比变化的影响。
目标 3 将检验这样一个假设，即对于身体不满意（这应该增加动机改变）和偏好一致性（这应该最大限度地诱导失调）的参与者，干预效果会被放大，而对于报告情绪化进食和物质使用的参与者（因为这些因素增加暴饮暴食的风险）。
研究类型
介入性
注册 (实际的)
364
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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Oregon
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Corvallis、Oregon、美国、97331
- Oregon State University
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Eugene、Oregon、美国、97403
- Oregon Research Institute
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Eugene、Oregon、美国、94703
- University of Oregon
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Texas
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Austin、Texas、美国、78713
- University of Texas, Austin
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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
17年 至 23年 (成人、孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
纳入标准：
- 大学生
- 出现自我报告的“体重问题”
排除标准：
- 饮食失调的诊断
- 肥胖
- 减持
- 不会说英语
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：预防
- 分配：随机化
- 介入模型：平行线
- 屏蔽：没有任何
武器和干预
参与者组/臂 |
干预/治疗 |
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ACTIVE_COMPARATOR：健康体重
健康体重干预的主要目标是每周对输入和输出进行小的、可持续的改变，以实现热量摄入和输出之间的平衡。
所有会议都以简要回顾上一节的内容、介绍教育讲义、仔细审查以前的行为改变目标以及为下一节制定健康的行为改变计划开始。
所有课程的家庭锻炼包括遵循个性化的饮食和锻炼目标，并保存食物和锻炼日志以确定未来健康变化的领域。
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实验性的：项目健康
Project Health 在健康体重基本干预措施中增加了引发失调的活动、讨论和家庭作业活动。
每节课都以参与的口头承诺开始（以强调参与的自愿性质），包括讨论已完成的家庭练习作业和课间写作/分享练习（以建立问责制），并以家庭练习结束（以提高努力）。
已完成的家庭作业会在后续课程中进行录像，以增加问责制。
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PLACEBO_COMPARATOR：控制
一些参与者将被随机分配到控制条件，由此他们将获得心理教育视频（“世界的重量”）以供观看。
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参与者将观看有关超重和肥胖的视频
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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 |
|---|---|---|
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体脂百分比
大体时间：从基线到 2 年随访的体脂变化
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我们将通过 Bod Pod S/T 使用空气置换体积描记法 (ADP) 来评估身体脂肪百分比。
两个措施将被平均。
身体密度，计算为体重除以估计的身体体积，用于根据规范参考数据计算年龄和性别调整后的身体脂肪百分位数（McCarthy 等人，2006 年）。
一项初步有效性研究 (N = 30) 显示，直接 DEXA 测量体脂百分比与 ADP 体脂估计值的相关性更强 (r = .88)
比 BMI (r = .23)。
2 年随访期间年龄和性别调整后体脂百分位的变化将是主要结果。
完成此评估需要 3-5 分钟。
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从基线到 2 年随访的体脂变化
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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饮食病理学
大体时间：基线和干预后（6 周）； 6/12/24 个月随访
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饮食失调诊断访谈是一种简短的半结构化访谈，将评估饮食失调症状。
它提供神经性厌食症、神经性贪食症和暴食症的诊断，这将使我们能够排除患有这些疾病的参与者。
它还提供了对总体饮食失调症状的连续测量。
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基线和干预后（6 周）； 6/12/24 个月随访
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负面影响
大体时间：基线和干预后（6 周）； 6/12/24 个月的随访
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正面和负面影响表（PANAS：Watson 等人，1988 年）的 20 项负面影响子量表测量一般负面情感和抑郁症状。
使用李克特评分系统，参与者选择他们对负面情感项目的认可程度，例如“厌恶自己”和“孤独”（反应选项：1 = 完全没有；5 = 非常）。
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基线和干预后（6 周）； 6/12/24 个月的随访
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食物渴望/喜欢
大体时间：基线、6 周（干预后）、6/12/24 个月的随访
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包含 28 项的食物渴望量表 (FCI; White et al., 2002) 评估了对个别食物（意大利面、冰淇淋）的主观渴望，并询问：“在过去的一个月里，你多久经历一次对食物的渴望？”
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基线、6 周（干预后）、6/12/24 个月的随访
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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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称量习惯
大体时间：基线和干预后（6 周）； 6/12/24 个月随访
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在每次评估中，将询问参与者“过去两周”称重的频率。
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基线和干预后（6 周）； 6/12/24 个月随访
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体力活动
大体时间：基线和干预后（6 周）； 6/12/24 个月的随访
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加速度计将在每次波浪评估中对每个参与者的身体活动进行客观测量。
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基线和干预后（6 周）； 6/12/24 个月的随访
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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
- 研究主任：Paul Rohde, PhD、Oregon Research Institute
- 研究主任：Heather Shaw, PhD、Oregon Research Institute
- 研究主任：Kyle Burger, PhD、Oregon Research Institute
- 研究主任：Nathan Marti, PhD、Oregon Research Institute
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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)
2012年9月1日
初级完成 (实际的)
2016年6月30日
研究完成 (实际的)
2018年5月31日
研究注册日期
首次提交
2012年8月29日
首先提交符合 QC 标准的
2012年9月3日
首次发布 (估计)
2012年9月7日
研究记录更新
最后更新发布 (实际的)
2018年9月21日
上次提交的符合 QC 标准的更新
2018年9月19日
最后验证
2018年9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.