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临床试验/NCT04023318
NCT04023318已完成不适用

A Novel Integrated Lifestyle Intervention to Reduce Obesity and Inflammation Among Emerging Adults

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
2
主要终点
Number of sessions attended throughout the intervention period

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 25 years
  • Body Mass Index between 25 and 45 kg/m2

排除标准

  • 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

结局指标

主要结局

Number of sessions attended throughout the intervention period

时间窗: 4 months

Attendance at in-person treatment sessions is one critical metric for demonstrating feasibility and will be tracked throughout the intervention period.

Number of days self-monitoring weight-related behaviors in LoseIt

时间窗: 4 months

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.

Number of days self-monitoring weight in LoseIt

时间窗: 4 months

Self-monitoring of weight is a critical metric for demonstrating feasibility and will be tracked throughout the intervention period.

次要结局

  • Change in sleep(Baseline and 4 months)
  • Percent Weight Change(Baseline and 4 months)
  • Change in diet(Baseline and 4 months)
  • Change in physical activity(Baseline and 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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