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心血管の健康と女性の健康行動の生物学的マーカーに関連する近隣環境ストレスの地理空間分析

女性の心臓血管の健康と健康行動の生物学的マーカーに関連する近隣環境ストレスの地理空間分析のためのパイロット研究

Background:

Heart disease is a leading cause of death in the United States. Healthy diet and exercise improve heart health. Some features of where a person lives can lead to stress and decrease chances for exercise. Researchers want to see how these factors may increase the risk of heart disease in women.

Objective:

To see if there are differences in stress levels between women who live in different parts of Washington, DC. Also, to see how these women use their neighborhoods for exercise.

Eligibility:

Healthy white or black females ages 19-45 who live in Washington, DC, who have access to a smartphone

Design:

Participants may stay at the NIH Clinical Center overnight for a 2-day visit.

Visit 1 will include:

Physical exam

Blood tests

Electrocardiogram: Electrodes on the participant s skin will measure heart activity.

PET/CT scan: Participants will get an injection. They will lie in a machine that takes pictures of the body.

Surveys

Body size measurements

Nutrition consultation

Blood vessel tests: This is measured with blood pressure cuffs, a device placed on the participant s fingertip, and a probe placed on the participant s neck.

Resting Energy Expenditure: Participants will breathe under a clear hood for 45 minutes.

Participants will be followed for about 2 weeks. They will wear a device on the wrist and carry a GPS device. Through a mobile app, they will answer short daily surveys on stress and exercise.

Visit 2-

Device return

Nutritional consultation

調査の概要

状態

募集

条件

詳細な説明

Innovative analyses of cardiovascular (CV) risk markers and heath behaviors in relation to neighborhood stressors are needed to further elucidate mechanisms by which adverse neighborhood conditions lead to poor CV outcomes. We propose to objectively measure physical activity, sedentary behavior, and neighborhood stress through accelerometers, global positioning systems (GPS), and ecological momentary assessment survey (via smartphone survey), linked to biological measures in a sample of White and African American women in Washington, D.C. neighborhoods. We hypothesize that individuals who are living in worse neighborhood environment conditions (e.g., higher poverty, crime, and social disorder) will be associated with higher chronic stress-related neural activity. As a secondary hypothesis, we hypothesize that associations between living in socio-economically disadvantaged neighborhood conditions and adverse biological markers will be moderated/mediated through levels of physical activity, time spent on sedentary activities, and dietary intake. Relationships between living in socio-economically disadvantaged neighborhood conditions and adverse biological markers will be also be mediated through psychosocial factors. In Aim 1, we will test associations between neighborhood environment conditions (e.g., poverty, crime, social disorder) and differences in stress-related neural activity, using PET CT-measured amygdala FDG uptake among a sample of White and African American women in high socio-economic status neighborhoods and low socioeconomic status neighborhoods in Washington D.C. In Aim 2a, we will determine associations between neighborhood environment conditions (e.g., poverty, crime, social disorder) and differences in cardiovascular risk and immune activation. Several measures of cardiovascular risk and immune activation will be performed including: (i) assessment of vascular function (vascular stiffness, vascular inflammation) and (ii) measures of immune function (i.e. flow cytometry for immune cell phenotyping, cytokine/chemokine/cortisol/neurotransmitter profiling, lipidomic analyses for lipid inflammatory intermediates, PBMC telomere length). In Aim 2b, we will assess feasibility and practicality of the use of geospatial tools and methods for measuring environmental factors (i.e. poverty, crime, social disorder) among this sample of women in Washington, DC. In aim 2c, we will examine whether associations between worse neighborhood environment conditions and adverse biological markers may be moderated and/or mediated by health behaviors (i.e., physical activity, sedentary time, dietary intake) and psychosocial factors (i.e., mood) measured via ecological momentary assessment (EMA). This project has a strong potential for improving scientific understanding of how neighborhood stress may influence biological measures of stress-related neural activity, such as amygdala activity, to improve our knowledge on interrelations among biology, environment, and cardiovascular health.

研究の種類

観察的

入学 (推定)

250

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Maryland
      • Bethesda、Maryland、アメリカ、20892
        • 募集
        • National Institutes of Health Clinical Center
        • コンタクト:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • 電話番号:TTY8664111010 800-411-1222
          • メール:prpl@cc.nih.gov

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

19年~45年 (大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

Recruitment will take place at both the NIH Clinical Center and at the NHLBI Hope Center. The proposed study will be cross-sectional with a sample of healthy White females (n=30) and healthy Black females of African descent (n=30) in Washington, DC. Participants will be asked to wear a GPS unit and accelerometer, and to use a smartphone (i.e., to measure perceived stress/mood via EMA) to examine associations between GIS-derived neighborhood variables, stress-related neural activity measures, and adverse biological markers. A sample of the women (n=30) will be recruited from the high SES census tracts within Washington, DC. The other participants (n=30) will be recruited from low SES census tracts in Washington DC. Finally, participants from high and low SES census tracts in Washington DC will be matched with respect to age, race, and body mass index [BMI].

説明

  • INCLUSION CRITERIA:

Individuals eligible for this protocol:

  1. A healthy self-identified White female (i.e. self-identifies as White or of European descent) or healthy Black female (i.e. self-identifies as Black, African American, or of African descent)
  2. Must be between 19 to 45 years of age
  3. Must not have any chronic health condition (i.e.: cardiovascular, autoimmune, endocrinologic), or active infection
  4. Must be living in Washington, DC
  5. Must have access to a smartphone
  6. Must be able to provide informed consent
  7. Must speak English.

EXCLUSION CRITERIA:

  1. Pregnant or breast feeding
  2. Physically unable to perform physical activity for any reason
  3. Subject had weight changes greater than 20% over the past 3 months
  4. Subject is obese by our measurements (BMI greater than or equal to 35.0 kg/m^2)
  5. If you have high or low blood pressure requiring medications
  6. Diabetes
  7. History of severe mental illnesses, treated with hospitalization
  8. If you have evidence of active thyroid disease requiring medications
  9. If you are taking medication for chronic non-mental health related illness (ie: cardiovascular, autoimmune, endocrinologic)
  10. If you have food allergies or highly restrictive diets that may prevent your ability to consume a controlled metabolic diet.
  11. If you are a current smoker (tobacco products)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:OTHER
  • 時間の展望:PROSPECTIVE

コホートと介入

グループ/コホート
Female

Diagnostic

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
Stress-related neural activity
時間枠:1 month

Stress-related neural activity will be estimated by neuroimaging (18-FDG PET/CT amygdala activity)

1 month

二次結果の測定

結果測定
メジャーの説明
時間枠
1) examine associations between neighborhood environment conditions
時間枠:1 month

rate of poverty, disorder, crime through both residential neighborhoods and individuals activity space and differences in cardiovascular risk and immune activation through: (i) assessment of vascular function (vascular stiffness, vascular inflammation); and (ii) measures of immune function (i.e. flow cytometry for immune cell phenotyping

1 month

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Tiffany M Powell-Wiley, M.D.、National Heart, Lung, and Blood Institute (NHLBI)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年10月20日

一次修了 (推定)

2026年12月10日

研究の完了 (推定)

2026年12月26日

試験登録日

最初に提出

2019年7月9日

QC基準を満たした最初の提出物

2019年7月9日

最初の投稿 (実際)

2019年7月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月11日

最終確認日

2026年11月9日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 190120
  • 19-H-0120

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

undecided

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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。