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

Study acronym: HC
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Primary completion date changed from estimate of Dec 2025 to Mar 9, 2026 Show 4 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Publications: details revised at 3 of 3 entries
    • Study description expanded, about 2 words
  2. Minor Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Site details revised
    v3
  3. Minor Eligibility criteria expanded, about 10 wordsv2
  4. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05974826
Lead Sponsor Foundation for Science, Health and Education, Spain
Collaborators: La Caixa Foundation, Hospital del Mar Research Institute (IMIM)
Conditions
(from sponsor)
Heart Disease Risk Factors, Healthy Lifestyle, Health Behavior
Related terms Health Behavior
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov