Clinical trial NCT05974826: Healthy Communities: a Healthy City Preventive Program on Cardiovascular Health and Well-being (HC)
Official title: Impact of a Healthy City Preventive Program on Cardiovascular Health and Well-being: a Quasi-Experimental Controlled Longitudinal Community-Based Study (Healthy Communities 2030)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Disease Risk Factors
Healthy Lifestyle
Health Behavior
Keywords: Healthy Lifestyle
Community health promotion
Peer-group
School-based intervention
Lead sponsor: Foundation for Science, Health and Education, Spain
Sponsor class: OTHER
Collaborators: name: La Caixa Foundation
name: Hospital del Mar Research Institute (IMIM)
First posted: 2023-08-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Changes of the Fuster-BEWAT
timeFrame: baseline, 3 and 5 years
Secondary outcomes:
measure: Changes at follow-up visits of individual domains of the Fuster-BEWAT score
timeFrame: baseline, 3 and 5 years
Other outcomes:
measure: Changes at follow-up visits of blood pressure
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of physical activity
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of body mass index
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of Mediterranean diet adherence
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of smoking status
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of blood glucose and lipid profile
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of body fat composition
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of muscle strength
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of psychosocial wellbeing
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of perceived stress
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of social support
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of resilience
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of self-esteem
timeFrame: baseline, 3 and 5 years
measure: Changes at follow-up visits of mood
timeFrame: baseline, 3 and 5 years
measure: Changes in the proportion of participants with any positive modifications in behavior
timeFrame: baseline, 3 and 5 years
Locations:
city: Madrid
country: Spain
facility: Foundation for Science, Health and Education
Study officials:
affiliation: Mount Sinaí Hospital
name: Valentín Fuster
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandez-Jimenez R, Santos-Beneit G, Tresserra-Rimbau A, Bodega P, de Miguel M, de Cos-Gandoy A, Rodriguez C, Carral V, Orrit X, Haro D, Carvajal I, Ibanez B, Storniolo C, Domenech M, Estruch R, Fernandez-Alvira JM, Lamuela-Raventos RM, Fuster V. Rationale and design of the school-based SI! Program to face obesity and promote health among Spanish adolescents: A cluster-randomized controlled trial. Am Heart J. 2019 Sep;215:27-40. doi: 10.1016/j.ahj.2019.03.014. Epub 2019 Apr 10.
citation: Fernandez-Alvira JM, Fuster V, Pocock S, Sanz J, Fernandez-Friera L, Laclaustra M, Fernandez-Jimenez R, Mendiguren J, Fernandez-Ortiz A, Ibanez B, Bueno H. Predicting Subclinical Atherosclerosis in Low-Risk Individuals: Ideal Cardiovascular Health Score and Fuster-BEWAT Score. J Am Coll Cardiol. 2017 Nov 14;70(20):2463-2473. doi: 10.1016/j.jacc.2017.09.032.
citation: Gomez-Pardo E, Fernandez-Alvira JM, Vilanova M, Haro D, Martinez R, Carvajal I, Carral V, Rodriguez C, de Miguel M, Bodega P, Santos-Beneit G, Penalvo JL, Marina I, Perez-Farinos N, Dal Re M, Villar C, Robledo T, Vedanthan R, Bansilal S, Fuster V. A Comprehensive Lifestyle Peer Group-Based Intervention on Cardiovascular Risk Factors: The Randomized Controlled Fifty-Fifty Program. J Am Coll Cardiol. 2016 Feb 9;67(5):476-85. doi: 10.1016/j.jacc.2015.10.033. Epub 2015 Nov 9.