Promoting healthier lifestyles and preventing chronic diseases in underserved urban communities across Europe
| ISRCTN | ISRCTN11383698 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11383698 |
| Secondary identifying numbers | Horizon Europe Grant Agreement number 101136516 |
- Submission date
- 12/06/2025
- Registration date
- 04/08/2025
- Last edited
- 04/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study aims to develop pilot interventions in three European countries (Croatia, the Netherlands and Spain) to promote behaviour change towards healthier lifestyles and to support citizens in making optimal use of the urban environment they live in while reducing risk behaviours related to chronic diseases, including type 2 diabetes and cardiovascular diseases. In comparison with ‘usual activities of citizens’, the HORUS concept is expected to achieve more favourable outcomes for low-income populations, migrants and ethnic minorities. This study aims to examine the effectiveness and implementation of HORUS in three large-scale pilots in Europe, including Rijeka (Croatia), Rotterdam (the Netherlands), and Valencia (Spain).
Who can participate?
Adults aged 18 years and older living in the participating areas
What does the study involve?
Each pilot site will design an intervention pathway based on the HORUS concept for the target population. The intervention will be supported by a mobile application (i.e., the Wakamola app) designed for citizen engagement. With informed consent, health or social care professionals will have access to a monitoring dashboard to track participant progress over time.
Data will be collected in pilot sites at inclusion (at the start of the HORUS intervention) and after 9 months to assess the benefits of the HORUS concept versus continuation of usual activities. Information on indicators of lifestyle behaviour, motivation, self-efficacy, health outcomes, use of the urban environment, and sense of belonging will be collected. In addition, the acceptability, appropriateness, feasibility, adoption, penetration, implementation costs, and sustainability of HORUS will be measured.
What are the possible benefits and risks of participating?
By participating in this study, individuals contribute to the development and evaluation of community-based prevention programs aimed at promoting healthier lifestyles and reducing the risk of chronic diseases such as type 2 diabetes and cardiovascular conditions. Participants in the intervention group may benefit from personalized support, including motivational interviewing, tailored health plans, and digital tools, to improve their nutrition, physical activity, and overall well-being. The intervention is designed with a particular focus on addressing the needs of low-income individuals, migrants, and ethnic minorities, and aims to support better use of local urban environments for health promotion.
As this is a non-invasive study, no significant risks for participants are foreseen.
Where is the study run from?
Universitat de Valencia (Spain)
When is the study starting and how long is it expected to run for?
July 2025 to June 2026
Who is the main contact?
The European HORUS study:
Tamara Alhambra Borrás, PhD, tamara.alhambra@uv.es
The pilot sites:
The Netherlands: Esmée Bally, PhD; e.bally@erasmusmc.nl
Croatia: Vanja Vasiljev, PhD; vanjav@medri.uniri.hr
Spain: Susana Rovira Llopis, PhD; susana.rovira@fisabio.es
Contact information
Public, Scientific, Principal Investigator
Edificio de Institutos de Investigación – Campus dels Tarongers
c/ Serpis nº29
Valencia
46022
Spain
 ORCID ID |
0000-0002-8595-1969 |
|---|---|
| Phone | +34 (0)961625484 |
| tamara.alhambra@uv.es |
Scientific
Wytemaweg 80
Rotterdam
3000 CA
Netherlands
| ORCID ID |
0000-0001-6767-9159 |
|---|---|
| Phone | +31 (0)107039163 |
| a.vangrieken@erasmusmc.nl |
Study information
| Study design | Multicenter mixed-methods pre-post controlled study design |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Health Outcomes from Raised Urban Settings (HORUS): a preventive community-based program to promote healthier lifestyles and prevent NCDs among socially disadvantaged populations in three European countries |
| Study acronym | HORUS |
| Study objectives | Citizens in the intervention group (i.e. individuals receiving HORUS) will have more favourable results with regard to indicators of healthy lifestyle behaviour compared with citizens participating in the comparison group (i.e. individuals continuing their usual activities). Furthermore, we will explore whether citizens in the intervention group make better use of the urban built environment for their health. |
| Ethics approval(s) |
1. Approved 30/04/2025, Comité Ético de Investigación con Medicamentos del Hospital Universitario Doctor Peset de Valencia (C/ San Lázaro s/n. Edificio CIPS 1ª Planta, Valencia, 46017, Spain; +34 (0)963131660; ceic_peset@gva.es), ref: 129/23 2. Approved 26/03/2024, Ethics Committee for Biomedical Research of the Faculty of Medicine of the University of Rijeka (Braće Branchetta 20, Rijeka, 51000, Croatia; +385 (0)51 651157 / +385 (0)51554901; mamaja.jancic@uniri.hr), ref: ref: 007-08/24-01/21; registry number: 2170-1-42-04-36/1-24-6 3. Submitted 28/05/2025, Medische Ethische Commissie (MEC), Erasmus University Medical Center Rotterdam (Dr. Molewaterplein 40, Rotterdam, 3015 GD, Netherlands; +31 (0)10-70 34428, +31 (0)10-70 33625; metc@erasmusmc.nl), ref: N/A |
| Health condition(s) or problem(s) studied | Prevention of non-communicable diseases in citizens with low income, migrants and ethnic minorities |
| Intervention | In Spain, participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Randomization will be performed using computer-generated random numbers to ensure allocation concealment and reduce selection bias. A randomization sequence will be generated using SPSS, which will automatically allocate each eligible participant to one of the two groups after enrollment. In the intervention condition, the HORUS concept will be implemented, while participants in the control group will continue with their usual activities. Each pilot site has the flexibility to adapt the general implementation framework of the HORUS concept to its specific local context. The intervention starts with a structured assessment using self-reported questionnaires to evaluate lifestyle behaviors, motivation, self-efficacy, health outcomes, use of the urban environment, and sense of belonging. This assessment aims to identify individual needs and inform personalized support strategies. Following the assessment, participants will engage in motivational interviewing to enhance intrinsic motivation for adopting healthier lifestyle behaviors. Based on the outcomes of both the assessment and motivational interview, a personalized intervention plan will be developed collaboratively by the participant and a health or social care professional. This co-produced plan will be reviewed periodically and adjusted as needed to support participants’ evolving health and wellbeing needs. The plan will emphasize at least promotion of healthy nutrition and physical activity. The intervention is supported by the HORUS technical solution, which facilitates implementation of the nutrition and physical activity components. Specific activities within each pilot site will be selected based on local relevance and available resources. The intervention will be supported by a mobile application (i.e., the Wakamola app) designed for citizen engagement. With informed consent, health or social care professionals will have access to a monitoring dashboard to track participant progress over time. Data will be collected at baseline (T0) and after 9 months (T1), using self-reported questionnaires. |
| Intervention type | Behavioural |
| Primary outcome measure | The primary outcome measure of lifestyle is measured using the following variables of diet, physical activity, alcohol consumption and smoking: 1. Diet is measured using the Rapid Prime Diet Score Screener (rPDQS) at baseline and after 9 months 2. Physical activity is measured using the International Physical Activity Questionnaire (IPAQ-SF) at baseline and after 9 months 3. Alcohol consumption is measured using the Alcohol Use Disorders Identification Test (AUDIT-C) at baseline and after 9 months 4. Smoking status is measured with 4 items, including the use of vapes at baseline and after 9 months. |
| Secondary outcome measures | 1. Self-efficacy is measured using the Nutrition Self-Efficacy Scale, Physical Exercise Self Efficacy Scale, and Alcohol Resistance Self Efficacy Scale at baseline and after 9 months. 2. Body Mass Index (BMI) is measured by asking length and weight of the participant at baseline and after 9 months 3. Chronic conditions are measured using the Cumulative Illness Rating Scale (CIRS) at baseline and after 9 months 4. Lifestyle advice is measured by core items of the WHO STEPwise approach to noncommunicable disease risk factor surveillance (WHO STEPS) at baseline and after 9 months 5. Health-Related Quality of Life is measured by the Patient Reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10) at baseline and after 9 months 6. Neighbourhood belonging is measured by 15 items in the Neighbourhood Cohesion Scale at baseline and after 9 months Implementation outcomes will be continuously measured with administrative data, questionnaire data and qualitative data in terms of acceptability, appropriateness, feasibility, adoption, penetration, implementation costs, and sustainability following the taxonomy of Proctor et al. (2011). |
| Overall study start date | 01/12/2023 |
| Completion date | 30/11/2026 |
Eligibility
| Participant type(s) | Resident |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 900 in total: 150 participants in the intervention group and 150 participants in the control group in each pilot site. |
| Key inclusion criteria | 1. Adults 18 years and older 2. Inhabitants of selected neighbourhoods within one of the pilot sites (Rijeka, Rotterdam and Valencia) 3. Able to give informed consent 4. Comprehension of the local language 5. Belong to one (or more) of the following groups: 5.1. General population from the selected vulnerable neighbourhood 5.2. Socially disadvantaged populations including low-income populations, migrants and ethnic minorities 5.3. Individuals who are at risk for NCDs or already have type 2 diabetes and/or CVD |
| Key exclusion criteria | 1. Individuals under the age of 18 years 2. Individuals living outside selected neighbourhoods 3. Individuals with severe or terminal illnesses unrelated to NCDs that could affect their ability to participate in the study 4. Participants with conditions requiring intensive medical care or beyond the intervention capabilities of the project 5. Individuals who do not fulfil the socioeconomic or ethnic criteria specified in the inclusion criteria 6. Individuals who do not consent or who are unwilling to participate in the data collection and study activities |
| Date of first enrolment | 01/07/2025 |
| Date of final enrolment | 01/06/2026 |
Locations
Countries of recruitment
- Croatia
- Netherlands
- Spain
Study participating centres
Rijeka
51000
Croatia
Rotterdam
3015 GD
Netherlands
Valencia
46010
Spain
Sponsor information
University/education
Blasco Ibanez Boulevard 13
Valencia
46010
Spain
| Phone | +34 (0)963 86 41 00 |
|---|---|
| e.mail@uv.es | |
| Website | https://www.uv.es/uvweb/college/en/university-valencia-1285845048380.html |
"ROR" |
https://ror.org/043nxc105 |
University/education
Wytemaweg 80
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 704 0704 |
|---|---|
| secretariaat.mgz@erasmusmc.nl | |
| Website | https://www.erasmusmc.nl |
|
"ROR" |
https://ror.org/018906e22 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Health and Digital Executive Agency, HaDEA
Results and Publications
| Intention to publish date | 01/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Publications in high-impact peer-reviewed journals. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
12/06/2025: Study's existence confirmed by the Comité Ético de Investigación con Medicamentos del Hospital Universitario Doctor Peset de Valencia.
