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

NCT05974826 | Active Not Recruiting

• 1 other identifier: SHE-003-HC
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease Risk Factors; Healthy Lifestyle; Health Behavior

Keywords

Healthy Lifestyle; Community health promotion; Peer-group; School-based intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes at follow-up visits of individual domains of the Fuster-BEWAT score

  baseline, 3 and 5 years

Other Outcomes (15)

• Changes at follow-up visits of blood pressure

  baseline, 3 and 5 years

• Changes at follow-up visits of physical activity

  baseline, 3 and 5 years

• Changes at follow-up visits of body mass index

  baseline, 3 and 5 years

Study Arms (2)

Community Intervention (town: Cardona)

EXPERIMENTAL

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)

Community Control (town: Sallent)

NO INTERVENTION

The participants on the control group only receive general health recommendation at the end of each assessment.

Interventions

the SI! Program for Secondary Schools (NCT03504059) BEHAVIORAL

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.

Community Intervention (town: Cardona)

the Fifty-Fifty Program (NCT02367963) BEHAVIORAL

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.

Community Intervention (town: Cardona)

Eligibility Criteria

• Age: 12 Years+
• Gender Eligibility Details: In order to try to equate groups in a quasi-experimental design, a normative age range- and sex- group equivalence matching approach will be used to select a comparison group that has approximately equivalent characteristics to the treatment group The recruitment will be stratified by sex and age-groups and a minimum of 75 and a maximum of 100 individuals in each strata will be recruited.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 12 years
• Registered in the local census of the selected towns (Cardona or Sallent)

You may not qualify if:

• Age less than 12 years
• Residency out of the selected towns (Cardona or Sallent)
• Unable/unwilling to provide informed consent
• Severe diseases

Sponsors & Collaborators

• Foundation for Science, Health and Education, Spain: lead
• La Caixa Foundation: collaborator
• Hospital del Mar Research Institute (IMIM): collaborator

Study Sites (1)

Foundation for Science, Health and Education

Madrid, Madrid, 28001, Spain

Location

Related Publications (3)

• 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.

  PMID: 31277052 BACKGROUND

• 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.

  PMID: 29145946 BACKGROUND

• 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.

  PMID: 26562047 BACKGROUND

Related Links

• Web of the SHE Foundation
• web of the Healthy Communities Program

MeSH Terms

Conditions

Health Behavior

Interventions

Schools

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Study Officials

• Valentín Fuster

  Mount Sinaí Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: August 3, 2023
• Study Start: October 20, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 9 months after publication
• Access Criteria: the de-identified data underlying results in a publication will be shared on reasonable request to the principal investigator. Email: estudio@fundacionshe.org

Locations

ES (1)