NCT01778712已完成不适用
Developing an Intervention to Prevent Visceral Adipose Tissue Accumulation in Premenopausal Women: WISHfit Phase 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in visceral adipose tissue, as measured by CT
研究概览
简要总结
The aim of this study is to develop an intervention that will produce a sustained improvement in physical activity and chronic stress as a means to slow the menopause-related accumulation of visceral adipose tissue in mid-life women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 42 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Resident of the Beverly or Morgan Park neighborhood of Chicago or contiguous neighborhoods
- •African American or Caucasian
- •Age 42 years or older
- •Intact uterus, at least one functioning ovary, at least one menstrual period in the last 12 months prior to screening.
- •Sufficient motivation level to make lifestyle changes, as determined by WISHFIT staff.
排除标准
- •Hysterectomy
- •Physical activity > 90 min per week
- •Metabolic conditions or use of medications that affect weight of visceral adipose tissue (diabetes, acquired immune deficiency syndrome, weight > 300 lbs)
- •Presence or history of major psychiatric comorbidity (i.e. dementia, schizophrenia, bipolar disorder, alcohol/drug addiction) in the last 6 months
- •History of inpatient mental health treatment
- •Currently prescribed antipsychotic medication
- •History of hallucinations or bizarre thoughts
- •Current pregnancy
- •Has been told by a physician that it is unsafe to engage in physical activity
- •An illness expected to limit functional status or life expectancy, including: heart failure, recent heart attack, liver cirrhosis, kidney failure, oncologic conditions, history or heart surgery, angioplasty or artery stenting.
结局指标
主要结局
Change in visceral adipose tissue, as measured by CT
时间窗: At two years from baseline
\<4% gain in visceral adipose tissue over a 2-year period
次要结局
- Effects of the multi-level intervention(At two years from baseline)
研究者
Lynda Powell, PhD, MEd
PhD, MEd
Rush University Medical Center
研究点 (2)
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