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临床试验/NCT01262313
NCT01262313已完成不适用

Healthy Creations: Community Based Lifestyle Intervention Validation

USDA Grand Forks Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2010年12月1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
发起方
入组人数
46
试验地点
2
主要终点
Percentage weight change from baseline

研究概览

简要总结

There remain important barriers to the translation of the programs like the Diabetes Prevention Program to public health. There is a lack of established lifestyle intervention programs as they are resource and time intensive, exceeding both the resources and the training of most primary care providers. A solution may be the implementation of lifestyle intervention programs in the community setting that are unrelated to primary medical care. A community based program at a public facility may extend the reach of lifestyle intervention to those unable to obtain these services from an established medical facility. Community lifestyle intervention to modify dietary, physical activity, and behavioral factors may be a promising strategy for weight management and the reduction of risk for metabolic disease. In this validation study we will assess pre and post intervention to identify whether measurable changes can be detected in body weight, body composition, markers of metabolic disease and quality of life after participation in the "Healthy Creations", a community based lifestyle intervention program presented by Center Court Fitness Center of the Grand Forks Park District and Altru Health System.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • overweight or Class I and II obese
  • live in Grand Forks, ND area

排除标准

  • history of eating disorder
  • pregnancy
  • inability to understand English or give consent
  • uncontrolled medical condition

研究组 & 干预措施

Control Group

Sham Comparator

The Control group will have an hour-long meeting of instruction by a registered dietitian on using the provided "A Healthier You: Everyday Healthy Eating and Physical Activity for Life" book, based on the Dietary Guidelines for Americans 2005.

干预措施: Lifestyle Counseling (Behavioral)

lifestyle counseling intervention

Experimental

This group will participate in the weekly "Healthy Creations" classes for 8 weeks presented by a Registered Dietitian and a certified fitness trainer. This is a community based lifestyle intervention program.

干预措施: Lifestyle Counseling (Behavioral)

结局指标

主要结局

Percentage weight change from baseline

时间窗: 20 weeks

Participants in the intervention group will attend an 8-week group intervention of "Healthy Creations. Participants in the control group will participate in one class on diet and physical activity presented by a dietitian.

次要结局

  • functional fitness(20 weeks)
  • insulin sensitivity(20 weeks)
  • Plasma Lipids(20 weeks)

研究者

发起方
USDA Grand Forks Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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