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Active Not Recruiting NCT05974826

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

Conditions: Heart Disease Risk Factors, Healthy Lifestyle, Health Behavior

Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 2000
Sponsor: Foundation for Science, Health and Education, Spain

Location: Foundation for Science, Health and Education Madrid Madrid

Summary

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.

Eligibility Criteria

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

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Source: ClinicalTrials.gov (NCT05974826). StuddyBuddy aggregates publicly available trial information.