The BMI Project (Body, Mind, Inflammation)
A Novel Integrated Lifestyle Intervention to Reduce Obesity and Inflammation Among Emerging Adults
Obesity and chronic inflammation influence the development and progression of many types of cancer. These conditions share several of the same causes, including physical inactivity, poor nutrition, stress, and insufficient sleep. Emerging adulthood (ages 18-25) represents an important developmental period in which to address behaviors and psychological variables that affect both weight status and inflammation. At least 40% of emerging adults have overweight/obesity, and this transition from adolescence to early adulthood is associated with significant increases in fast food consumption, decreases in physical activity, unpredictable sleep schedules, and alarmingly high rates of depression and perceived stress.
Despite this high risk for obesity, very few weight loss interventions are designed specifically for emerging adults. Preliminary findings from weight loss interventions targeting this population have shown some promise, but generally produce modest outcomes with less consistent effects than programs in older adults. Depression and stress have been found to interfere with weight loss among emerging adults, and may be in part responsible for poorer outcomes. This proposal will develop and test an Integrated Lifestyle Intervention (ILI) that comprehensively addresses both psychological distress and traditional weight management targets. This novel approach has not been tested before and has the potential not only to enhance weight loss outcomes in this high risk population, but also to produce reductions in markers of inflammation beyond those achievable by weight loss alone.
研究概览
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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Virginia
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Richmond、Virginia、美国、23219
- Virginia Commonwealth University
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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:
- Age between 18 and 25 years
- Body Mass Index between 25 and 45 kg/m2
Exclusion Criteria:
- Currently pregnant or lactating; pregnancy in the last 6 months or plans to become pregnant in the next 6 months
- Type 1 or type 2 diabetes
- Any uncontrolled medical conditions that could make it unsafe to participate in unsupervised exercise
- Medical conditions associated with chronic inflammation
- Inability to read, understand and speak English
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Integrated Lifestyle Intervention
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This program is grounded in data demonstrating the dysregulation across multiple domains and considerable life stressors experienced by this population.
The central hypothesis is that by simultaneously ameliorating psychological dysregulation and directly targeting proinflammatory behaviors, ILI operates on multiple proposed mediators of poor treatment outcomes in this population, thereby enhancing treatment outcomes.
As such, the overall framework emphasizes integration of self-regulation as it applies to both psychological functioning and weight control.
Content will highlight the interconnectedness of mood, stress, eating and exercise behaviors, and risk for inflammation and disease.
Each treatment session will present a combination of behavioral and psychological content, representing a truly integrated approach.
Participants will meet for 75-minute group sessions weekly for months 1-2, followed by bi-weekly groups in months 3-4, for a total of 12 groups.
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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 |
---|---|---|
Number of sessions attended throughout the intervention period
大体时间:4 months
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Attendance at in-person treatment sessions is one critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
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4 months
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Number of days self-monitoring weight in LoseIt
大体时间:4 months
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Self-monitoring of weight is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
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4 months
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Number of days self-monitoring weight-related behaviors in LoseIt
大体时间:4 months
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Self-monitoring of weight-related behaviors (e.g., diet and physical activity) is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.
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4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in diet
大体时间:Baseline and 4 months
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Dietary change will be assessed using the Diet History Questionnaire III (DHQ-III), a 166-item adaptive questionnaire developed by NCI which maps on to dietary intervention targets (e.g., saturated fat, alcohol, sugar, fiber, sodium), as well as a measure of overall diet.
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Baseline and 4 months
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Change in physical activity
大体时间:Baseline and 4 months
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Participants will report their physical activity using the 6-item Paffenbarger Physical Activity Questionnaire, which yields estimates of minutes spent in moderate-to-vigorous physical activity.
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Baseline and 4 months
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Change in sleep
大体时间:Baseline and 4 months
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The EARLY Trials Common Elements Sleep Questionnaire (8 items) will be administered that asks about duration of sleep and problems encountered during sleep (e.g.
snoring).
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Baseline and 4 months
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Percent Weight Change
大体时间:Baseline and 4 months
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Weight will be measured in light clothes, without shoes, on calibrated Tanita BWB-800S scales.
Percent change of initial body weight will be calculated using baseline and 4 month weights.
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Baseline and 4 months
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合作者和调查者
调查人员
- 首席研究员:Jessica LaRose, PhD、Virginia Commonwealth University
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
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.
Integrated Lifestyle Intervention的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动,不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动,不招人
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Portsmouth Hospitals NHS TrustPfizer; The Health Foundation; Wessex Academic Health Science Network; East Hampshire Better Local...完全的
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University of WashingtonNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)完全的