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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of a Healthy City Preventive Program on Cardiovascular Health and Well-being: a Quasi-Experimental Controlled Longitudinal Community-Based Study (Healthy Communities 2030)

Conditions
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Heart Disease Risk Factors, Healthy Lifestyle, Health Behavior

Intervention / Treatment
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* Behavioral: the SI! Program for Secondary Schools (NCT03504059)
* Behavioral: the Fifty-Fifty Program (NCT02367963)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community Intervention (town: Cardona)<br>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 | Behavioral: the SI! Program for Secondary Schools (NCT03504059)<br>* 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.<br>Behavioral: the Fifty-Fifty Program (NCT02367963)<br>* 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 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.<br>|
| No Intervention: Community Control (town: Sallent)<br>The participants on the control group only receive general health recommendation at the end of each assessment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the Fuster-BEWAT | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes at follow-up visits of individual domains of the Fuster-BEWAT score | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Lifestyle, Peer-group, Community health promotion, School-based intervention