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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 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.
研究组 & 干预措施
Intervention
Experimental
Multi-level intervention
干预措施: Multi-level intervention (Behavioral)
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 (1)
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