An interventional study of the SI! Program for Secondary Schools (NCT03504059) and the Fifty-Fifty Program (NCT02367963) in Heart Disease Risk Factors, Healthy Lifestyle and Health Behavior, sponsored by Foundation for Science, Health and Education, Spain. Active, not recruiting at 1 site in Spain. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Foundation for Science, Health and Education, Spain · Not applicable, Interventional, and Prevention
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.
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.).
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.
228 studies on the registry are indexed under Health Behavior; 95 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 114 across 196 interventional studies indexed under Health Behavior.
Browse Health Behavior studies →Foundation for Science, Health and Education, Spain is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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) · Behavioral: the Fifty-Fifty Program (NCT02367963)
The participants on the control group only receive general health recommendation at the end of each assessment.
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.
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).
Time frame: baseline, 3 and 5 years
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.
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of blood pressure
Mean and change in blood pressure (systolic and diastolic) (mmHg) as assessed with a fully automated blood pressure monitor (OMRON M6 monitor).
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of physical activity
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).
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of body mass index
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.
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of Mediterranean diet adherence
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).
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of smoking status
Mean and change in smoking status as evaluated by self-reported the average number of cigarettes products consumed daily.
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of blood glucose and lipid profile
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.
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of body fat composition
Mean and change in body fat mass and body lean mass as measured by bioelectrical impedance.
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of muscle strength
Mean and change in muscle strength evaluated by the hand-grip test (kg)
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of psychosocial wellbeing
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).
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of perceived stress
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).
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of social support
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).
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of resilience
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).
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of self-esteem
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).
Time frame: baseline, 3 and 5 years
Changes at follow-up visits of mood
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).
Time frame: baseline, 3 and 5 years
Changes in the proportion of participants with any positive modifications in behavior
Changes in the proportion of participants with any positive modifications in behavior
Time frame: baseline, 3 and 5 years
Plan to share: Yes — The de-identified data underlying results in a publication will be shared on reasonable request to the principal investigator.
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Foundation for Science, Health and Education, Spain