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Total Health Improvement Program Research Project

2022年5月5日 更新者:Heidi Beery、Pacific Northwest University of Health Sciences

Total Health Improvement Program Research Project (A Community Lifestyle Medicine Course and Ability to Improve Health in All Classes of Socioeconomic Status)

The purpose of this study is to assess the effectiveness a 13-week community based nutrition education program to assist participants program in improving in physical and emotional well being and to assess if there are differences in outcomes based on a participant's socioeconomic status.

研究概览

详细说明

Little is known about effective strategies to reduce inequalities in non-communicable diseases (NCDs) and their underlying behaviors. McGill et al did a systematic review of the socioeconomic inequalities in promoting healthy eating. They found that upstream interventions with policy changes on price (fiscal measures such as taxes, subsidies, or economic incentives) reduced socioeconomic inequalities compared to downstream interventions such as cooking lessons, tailored nutritional education/counseling or nutrition education in the school curriculum appear likely to widen inequalities.

Douglas County's average income is $44,023 (compared to the median annual income of $60,336 across the entire United States) and the 5th poorest county in the state. 17% of the population is in poverty, higher than the national average of 13.4%.

The Complete Health Improvement Program (CHIP) is a premier lifestyle intervention that has been offered for more than 25 years and has been shown in over 25 peer-reviewed publications to benefit chronic disease. The Complete Health Improvement Program (CHIP) is a premier lifestyle intervention that has been offered for more than 25 years and has been shown in over 25 peer-reviewed publications to benefit chronic disease. CHIP was initially offered in Douglas County 5 years ago and found to benefit participants but there were concerns that it was widening inequalities due to the cost of the class. A similar program named Total Health Improvement Program (THIP) was designed and offered to the community for free through the partnership of a non-profit organization called UC-VEG.

The purpose of this study is to determine the effectiveness of the 13-week community-based nutrition education THIP program to assist participants with the adoption of a plant-based diet, increase physical activity and increase positive psychology. Research has shown plant-based diets to be safe and effective for weight management or reduction, cholesterol management, hypertension and diabetes management, and overall health and longevity. The primary objectives are to assess the effectiveness of the program in improving physical and emotional well-being and to assess if there are differences in outcomes based on a participant's socioeconomic status.

研究类型

观察性的

注册 (实际的)

45

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Oregon
      • Roseburg、Oregon、美国、97471
        • Better Living Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adults who have at least one chronic disease and may or maynot be economically or educationally disadvantaged.

描述

Inclusion Criteria:

  • Speak English
  • 18 years of age or older
  • Prepared to engage in the Total health Improvement Program (THIP) weekly educational classes (13 weeks)
  • Willing to participate in the pre and post questionnaire
  • Able to participate in the lab work at weeks 2 and 12
  • Have at least one chronic disease including cardiovascular disease, hyperlipidemia, hypertension, obesity (BMI >30), diabetes, or pre-diabetes (A1C>5.7%)
  • Able to provide their own meals (whole foods diet)
  • Has not attended the THIP program in the last year

Exclusion Criteria:

  • Non English Speakers
  • Less than 18 years of age
  • Unwilling to engage in the Total health Improvement Program (THIP) weekly educational classes (13 weeks)
  • Unwilling to participate in the pre and post questionnaire
  • Not able to participate in the lab work at weeks 2 and 12
  • Do not have at least one chronic disease including cardiovascular disease, hypertension, diabetes or pre-diabetes (A1C>5.7%)
  • Unable to provide their own meals (whole foods diet)
  • Has attended the THIP program in the last year

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change from Baseline - Global Health Score
大体时间:12 weeks
Change in global health score as measured by the validated SF-20 survey. The survey is scored for limitations in physical and role functioning (a higher score value indicates better functioning, for mental health (a higher score value indicates better health) and for pain (a higher score value indicates more pain).
12 weeks
Correlation of Global Health Scores to Social Determinants of Health
大体时间:12 weeks
The primary analysis will be to determine if changes in SF-20 score are correlated with scores from the PCS3 Socioeconomic Survey to determine the relationship, if any, between socioeconomic status and changes in global health.
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Change from Baseline - Weight
大体时间:12 Weeks
The participants will be weighed at week 2 (baseline) and week 12. The data will be analyzed to determine effectiveness of the Total Health Improvement Program.
12 Weeks
Change from Baseline - Abdominal Circumference
大体时间:12 Weeks
The participants will have there abdominal circumference measured at week 2 (baseline) and week 12. The data will be analyzed to determine effectiveness of the Total Health Improvement Program.
12 Weeks
Change from Baseline - HbA1C
大体时间:12 Weeks
The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
12 Weeks
Change from Baseline - Total Cholesterol
大体时间:12 Weeks
The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
12 Weeks
Change from Baseline - Triglycerides
大体时间:12 Weeks
The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
12 Weeks
Change from Baseline - LDL Cholesterol
大体时间:12 Weeks
The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
12 Weeks
Change from Baseline - HDL Cholesterol Ratio
大体时间:12 Weeks
The participants will have blood draws at week 2 (baseline) and week 12 and results will be compared to determine effectiveness of the Total Health Improvement Program. .
12 Weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Heidi Beery, MD、Pacific Northwest University of Health Science

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年9月4日

初级完成 (实际的)

2020年6月1日

研究完成 (实际的)

2021年8月12日

研究注册日期

首次提交

2019年8月28日

首先提交符合 QC 标准的

2019年9月6日

首次发布 (实际的)

2019年9月9日

研究记录更新

最后更新发布 (实际的)

2022年5月9日

上次提交的符合 QC 标准的更新

2022年5月5日

最后验证

2022年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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