Total Health Improvement Program Research Project
Total Health Improvement Program Research Project (A Community Lifestyle Medicine Course and Ability to Improve Health in All Classes of Socioeconomic Status)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Oregon
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Roseburg、Oregon、アメリカ、97471
- Better Living Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline - Global Health Score
時間枠：12 weeks
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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).
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12 weeks
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Correlation of Global Health Scores to Social Determinants of Health
時間枠：12 weeks
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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.
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12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline - Weight
時間枠：12 Weeks
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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.
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12 Weeks
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Change from Baseline - Abdominal Circumference
時間枠：12 Weeks
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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.
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12 Weeks
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Change from Baseline - HbA1C
時間枠：12 Weeks
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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. .
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12 Weeks
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Change from Baseline - Total Cholesterol
時間枠：12 Weeks
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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. .
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12 Weeks
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Change from Baseline - Triglycerides
時間枠：12 Weeks
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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. .
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12 Weeks
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Change from Baseline - LDL Cholesterol
時間枠：12 Weeks
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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. .
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12 Weeks
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Change from Baseline - HDL Cholesterol Ratio
時間枠：12 Weeks
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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. .
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12 Weeks
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協力者と研究者
捜査官
- 主任研究者：Heidi Beery, MD、Pacific Northwest University of Health Science
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。