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临床试验/NCT03929198
NCT03929198已完成不适用

Population-Based Lifestyle Intervention: Translation of the Pritikin Program to the Community- Pilot Study Protocol

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年9月27日最近更新:
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
54
试验地点
1
主要终点
Blood Pressure

研究概览

简要总结

The broad, long-term aims of this scope of work are to investigate the effects of the Pritikin Program to the general population. The study will test the effects on individuals from the community with dysfunctional lipids, blood pressure and glycemic control. To assess the effectiveness of the Pritikin Program in the community, the effects of Pritikin lifestyle intervention on overall health will be investigated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Dysfunctional lipids, blood pressure and glycemic control determined at a screening visit:
  • •Triglycerides > 150 mg/dL OR HDL <50 in females, <40 mg/dL in males
  • •Systolic blood pressure ≥130 mmHg OR diastolic blood pressure ≥80 mmHg (or on hypertension medication)
  • •HbA1c ≥5.7% or higher
  • •No diagnosis or treatment for cancer in the past year
  • •No diagnosis of mild cognitive impairment or dementia in the past year
  • •Ability to perform daily exercise, including aerobic activity and resistance exercise
  • •Non-smoker in the past year

排除标准

  • •Positive exercise stress test

研究组 & 干预措施

Intervention

Experimental

The intervention group participated in a 6-week Pritikin diet, exercise program, and behavioral modification.

干预措施: Healthy Lifestyle (Other)

Control

No Intervention

This group did not receive any intervention.

结局指标

主要结局

Blood Pressure

时间窗: 6 weeks

Cholesterol

时间窗: 6 weeks

Triglycerides

时间窗: 6 weeks

Body Weight

时间窗: 6 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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