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

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.

Conditions

• Heart Disease Risk Factors
• Healthy Lifestyle
• Health Behavior

Interventions

BEHAVIORAL

the SI! Program for Secondary Schools (NCT03504059)

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.

BEHAVIORAL

the Fifty-Fifty Program (NCT02367963)

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.

Sponsors & Collaborators

• La Caixa Foundation

  collaborator OTHER

• Hospital del Mar Research Institute (IMIM)

  collaborator OTHER

• Foundation for Science, Health and Education, Spain

  lead OTHER

Principal Investigators

• Valentín Fuster · Mount Sinaí Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-20

Primary Completion

2025-12-31

Completion

2030-12-31

Countries

• Spain

Study Locations