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Healthy Communities: A Healthy City Preventive Program on Cardiovascular Health and Well-being (HC) (HC)

健康都市予防プログラムが心臓血管の健康と幸福に及ぼす影響: 準実験的対照縦断地域ベース研究 (Healthy Communities 2030)

Healthy Communities is a multidisciplinary health-promotion initiative. The objective of the present study is to determine whether such an intervention will be efficacious to improve cardiovascular health compared to the current approach.

A quasi-experimental controlled longitudinal community-based intervention study will be carried out comprising approximately 2000 individuals from the age of 12 years from the cities of Cardona (intervention city) and Sallent (control city), in Spain. The core of the intervention will be based on the previous health promotion programs developed and evaluated by the Science, Health and Education (SHE) Foundation: the SI! Program (Salud Integral -Comprehensive Health) for children, and the Fifty-Fifty Program for adults. Coupled to infrastructure development, we will promote the understanding of the benefits of active living to increase awareness on the relevance of healthy lifestyle to improve health and wellbeing in three consecutive phases (Phase 1- full supervised program; Phase 2- transition period, and Phase 3- self-community driven program), which will provide full empowerment to the community.

The primary outcome will be measured with the validated composite Fuster-BEWAT (Blood pressure, Exercise/physical activity, body Weight/BMI, Alimentation/diet, and Tobbaco/smoking) score consisting of a 0-15 scale for behaviors/health risk factors. Assessments will be performed at baseline, at 2.5 and 5 years. Follow-up assessments will be conducted to determine the between group differences (intervention vs. control) in the change of the Fuster-BEWAT score at phase 2 and phase 3.

調査の概要

詳細な説明

Healthy Communities is a multidisciplinary health-promotion initiative aiming to improve the health and wellbeing of individuals using an innovative combination of programs and urban design to build up a "culture of health". The main aim is to turn cities and towns into places where individuals, families, and communities can increase their health and welfare potential, and where working toward cardiovascular health and wellbeing is everyone's business.

The objective of the present study is to determine whether such an intervention will be efficacious compared to the current approach.

The hypothesize is that a healthy city will impact positively to their inhabitants by improving cardiovascular health and physical activity indices, mental health, and wellbeing. For such a purpose, a controlled longitudinal community-based intervention study will be carried out on 2000 participants (1000 in the intervention and 1000 in the control towns) 12 years or older over a period of 5 years.

The core of the intervention will be based on the previous health promotion programs developed and evaluated by the Science, Health and Education (SHE) Foundation: the SI! Program for children, and the "Fifty-Fifty" Program for adults. The effect of these interventions was proven through randomized trials and the results were published in high-impact journals (Journal of the American College of Cardiology, American Heart Journal, American Journal of Medicine, etc.).

  • The "SI!" Program is a school-based intervention aimed at promoting cardiovascular Health among children aged 3 to 16 years using their proximal environment (school, teachers, and families). The intervention is designed to instill and develop healthy behaviors in relation to diet, physical activity, and emotions, all connected to cardiovascular health.
  • The "Fifty-Fifty" Program is a peer-group based intervention about topics related to physical activity, nutrition, and psychological aspects of lifestyle change, which is adapted to 3 different aged groups: "Fifty-Action" for young adults aged 17 to 24 years, "Fifty-Fifty" for people aged 25 to 50 years and "Fifty-Plus" for people over 51 years of age.

Coupled to infrastructure development, we will promote the understanding of the benefits of active living to increase awareness on the relevance of healthy lifestyle to improve health and wellbeing in three consecutive phases, which will provide full empowerment to the community.

During the first phase, a full educational and behavioral change program with specific actions and activities to engage and promote health and wellbeing in the community will be implemented; while the second phase will be a transition period where the Cardona inhabitants will progressively acquire a key role in such implementation under moderate supervision. Finally, during phase 3, we expect that the community will become totally empowered to drive their own health and wellbeing promotion program under minimal supervision. A non-intervention town -Sallent, in the same area- will serve as control group.

The primary outcome will be measured with the validated composite Fuster-BEWAT score consisting of a 0-15 scale for behaviors/health risk factors related to Blood pressure, Exercise, Weight, Alimentation (diet), and Tobacco (smoking). Assessments will be performed at baseline, at 2.5 and 5 years. Follow-up assessments will be used to calculate the between group differences (intervention vs. control) for the change in the Fuster-BEWAT score at midpoint of phase 2 (after the full supervised program and during the transition period), and at phase 3 (self-community driven program). Each study visit will include clinical interview, physical examination (height, weight, waist circumference, blood pressure and heart rate), point-of-care testing of lipid and glucose profile, lifestyle and behavior questionnaires, assessment of physical activity, evaluation of muscle strength and muscle quality, and assessment of psychosocial well-being. Trained health personnel will conduct all interviews and measurements.

研究の種類

介入

入学 (推定)

2000

段階

  • 適用できない

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。

研究場所

    • Madrid
      • Madrid、Madrid、スペイン、28001
        • Foundation for Science, Health and Education

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

12年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Age greater than or equal to 12 years
  • Registered in the local census of the selected towns (Cardona or Sallent)

Exclusion Criteria:

  • Age less than 12 years
  • Residency out of the selected towns (Cardona or Sallent)
  • Unable/unwilling to provide informed consent
  • Severe diseases

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

  • 主な目的:防止
  • 割り当て:非ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Community Intervention (town: Cardona)

The interventions aim to encourage a healthy lifestyle, including diet education, physical activity, and wellbeing.

The SI! Program for Secondary Schools: a four-year specially designed educational program for adolescents is applied.

The Fifty-Fifty Program implies two stages: 1) Training period; 2) a Peer-group intervention, designed to make the subjects participate actively in their healthcare

The SI! Program is implemented from 1st to 4th grade of Secondary Schools. A total of 12 hours of classroom intervention per academic year, organized through three educational units, and with active and participative methodologies, and complementary intervention in the family setting, at school and on teachers.

  1. Training stage: the focus is on improving individual health, through workshops (given in person by experts), and on the challenges of changing habits supervised and supported by the SHE Foundation
  2. Peer-to-peer support group sessions: It is designed to make the subjects participate actively in their healthcare. Along the sessions subjects propose assumable health goals. Participants will be able to view videos with key messages from the workshops to continue the sustainability of the changes made, and the development of new ones. Peer-to-peer support group sessions have two phases: a) leaders will receive support from the Foundation; b) participants will become agents of change with the people around them, and also in their municipality with specific actions to promote health. The role of Foundation's will only be to monitor and resolve possible doubts.
介入なし:Community Control (town: Sallent)

The participants on the control group only receive general health recommendation at the end of each assessment.

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
Changes of the Fuster-BEWAT
時間枠:baseline, 3 and 5 years

The primary outcome will be the change from baseline in composite Fuster-BEWAT score consisting of a 0-15 scale for the following behaviors/health risk factors (higher scores correspond to healthier lifestyles): Blood pressure (systolic and diastolic blood pressure), Exercise (minutes of vigorous and moderate physical activity), Weight (body mass index calculated as body weight divided by height squared (kg/m2), Alimentation (diet) (fruits and vegetables consumption), and Tobacco (smoking) (smoking status and number of cigarettes) (0-3 points for each domain). Higher scores correspond to healthier lifestyle behaviors. The primary outcome is whether individuals belonging to a lifestyle intervention program (intervention group) demonstrate an improvement of health related behaviors and biological parameters compared to the self-management approach (control group).

baseline, 3 and 5 years

二次結果の測定

結果測定
メジャーの説明
時間枠
Changes at follow-up visits of individual domains of the Fuster-BEWAT score
時間枠:baseline, 3 and 5 years

Mean score and change at follow-up visits for each of the individual domains assimilated in the composite Fuster-BEWAT score (0-3 points for each domain, higher scores correspond to healthier lifestyles): Blood pressure (systolic and diastolic blood pressure), Exercise (minutes of vigorous and moderate physical activity), Weight (body mass index calculated as body weight divided by height squared (kg/m2)), Alimentation (diet) (fruits and vegetables consumption), and Tobacco (smoking) (smoking status and number of cigarettes). Higher scores correspond to higher compliance to lifestyle guidelines.

baseline, 3 and 5 years

その他の成果指標

結果測定
メジャーの説明
時間枠
Changes at follow-up visits of blood pressure
時間枠:baseline, 3 and 5 years

Mean and change in blood pressure (systolic and diastolic) (mmHg) as assessed with a fully automated blood pressure monitor (OMRON M6 monitor).

baseline, 3 and 5 years
Changes at follow-up visits of physical activity
時間枠:baseline, 3 and 5 years

Mean and change in physical activity as evaluated by self-reported the short version of the Minnesota Leisure Time Physical Activity Questionnaire (REGICOR). The questionnaire calculates energy expenditure from total physical activity, and from light, moderate and vigorous physical activity (minutes per week).

baseline, 3 and 5 years
Changes at follow-up visits of body mass index
時間枠:baseline, 3 and 5 years

Mean and change in body mass index (kg/m2). Body height as measured using a stadiometer (Seca 213). Body weight as measured using the OMRON BF511 electronic scale.

baseline, 3 and 5 years
Changes at follow-up visits of Mediterranean diet adherence
時間枠:baseline, 3 and 5 years

Change in the adherence to a Mediterranean diet as evaluated by a self-reported the Short Diet Quality Screener (SDQS) questionnaire. Score range=0-36 (higher scores correspond to highest healthy diet).

baseline, 3 and 5 years
Changes at follow-up visits of smoking status
時間枠:baseline, 3 and 5 years

Mean and change in smoking status as evaluated by self-reported the average number of cigarettes products consumed daily.

baseline, 3 and 5 years
Changes at follow-up visits of blood glucose and lipid profile
時間枠:baseline, 3 and 5 years

Mean total, LDL- and HDL-cholesterol (mg/dL), and blood glucose (mg/dL) and change at follow-up visits as evaluated by point-of-care testing. Blood glucose and lipid profile were measured using a CardioCheck Plus device and PTS-Panels test strips in capillary blood sampled with a lancet in fasting status.

baseline, 3 and 5 years
Changes at follow-up visits of body fat composition
時間枠:baseline, 3 and 5 years

Mean and change in body fat mass and body lean mass as measured by bioelectrical impedance.

baseline, 3 and 5 years
Changes at follow-up visits of muscle strength
時間枠:baseline, 3 and 5 years

Mean and change in muscle strength evaluated by the hand-grip test (kg)

baseline, 3 and 5 years
Changes at follow-up visits of psychosocial wellbeing
時間枠:baseline, 3 and 5 years

Change in psychosocial wellbeing as evaluated by self-reported questionnaire about perceived happiness (Pemberton Happiness Index), Score range=0-10 (higher scores correspond to highest psychosocial wellbeing).

baseline, 3 and 5 years
Changes at follow-up visits of perceived stress
時間枠:baseline, 3 and 5 years

Change in perceived stress as evaluated by self-reported questionnaire Perceived Stress Scale (14-items PSS). Score range=0-56 (higher scores correspond to highest perceived stress).

baseline, 3 and 5 years
Changes at follow-up visits of social support
時間枠:baseline, 3 and 5 years

Change in social support as evaluated by self-reported questionnaire Spanish-translated ENRICHD Social Support Instrument. Score range=0-21 (higher scores correspond to highest social support).

baseline, 3 and 5 years
Changes at follow-up visits of resilience
時間枠:baseline, 3 and 5 years

Change in resilience as evaluated by self-reported questionnaire Spanish-adaptation of Brief Resilience Coping Scale. Score range=4-20 (higher scores correspond to highest resilience).

baseline, 3 and 5 years
Changes at follow-up visits of self-esteem
時間枠:baseline, 3 and 5 years

Change in self-esteem as evaluated by self-reported questionnaire Child Health and Illness Profile-Adolescent Edition (CHIP-AE). Score range=1-20 (higher scores correspond to highest self-esteem).

baseline, 3 and 5 years
Changes at follow-up visits of mood
時間枠:baseline, 3 and 5 years

Change in mood as evaluated by self-reported a Spanish questionnaire design by Vazquez-Fernandez ME et al 2013. Score range=0-6 (scoring ≥3 means mood is negative).

baseline, 3 and 5 years
Changes in the proportion of participants with any positive modifications in behavior
時間枠:baseline, 3 and 5 years

Changes in the proportion of participants with any positive modifications in behavior

baseline, 3 and 5 years

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。

捜査官

  • 主任研究者:Valentín Fuster、Mount Sinaí Hospital

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 (実際)

2026年3月9日

研究の完了 (推定)

2030年12月1日

試験登録日

最初に提出

2023年3月8日

QC基準を満たした最初の提出物

2023年7月26日

最初の投稿 (実際)

2023年8月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月23日

QC基準を満たした最後の更新が送信されました

2026年9月21日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

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?

はい

IPD プランの説明

The de-identified data underlying results in a publication will be shared on reasonable request to the principal investigator.

IPD 共有時間枠

Starting 9 months after publication

IPD 共有アクセス基準

the de-identified data underlying results in a publication will be shared on reasonable request to the principal investigator.

Email: estudio@fundacionshe.org

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米国FDA規制機器製品の研究

いいえ

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