Healthy LifestyleSENPRINCT07189533
SENior PRIorat: Participatory Research for the Improvement of Lifestyles, Quality of Life, Emotional Well-being, and Locomotor Abilities of Older Adults in the Priorat
A study testing Co-created intervention in people with Healthy Lifestyle, run by University Rovira i Virgili at 1 site in Spain.
Trial summary
Spain is experiencing a demographic shift towards an ageing population. In 2022, 20.1% of Spaniards were 65 or older, a figure projected to reach 30.4% by 2050. The trend is especially marked in rural areas, where outmigration of younger generations has left a high concentration of older residents. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- Co-created intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 6 Oct 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 60 years or older
- Signed informed consent
- Living independently
- Capacity to follow and complete the study
- Resident in one of the villages of the Priorat region
Who cannot join
- Failure to meet any of the inclusion criteria will be considered grounds for exclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universitat Rovira i Virgili
Reus, Tarragona, 43201
Elisabet Llauradó, PhD, +34977759375, elisabet.llaurado@urv.cat
About this study
Official title: SENior PRIorat: Ciencia Participativa Para la Mejora de Los Estilos de Vida, la Calidad de Vida, el Bienestar Emocional y Las Capacidades Locomotoras de Las Personas Mayores Del Priorat
Spain is experiencing a demographic shift towards an ageing population. In 2022, 20.1% of Spaniards were 65 or older, a figure projected to reach 30.4% by 2050. The trend is especially marked in rural areas, where outmigration of younger generations has left a high concentration of older residents. In Catalonia's Priorat county, the share of people aged 65+ already exceeds 20%, reaching 30%, and even 40% in some villages.
The ageing process brings biological changes that reduce locomotor and cognitive abilities, limiting autonomy and quality of life. In rural areas, these challenges are compounded by social isolation and the lack of support networks, making older adults more vulnerable. Healthy lifestyle habits-such as balanced nutrition, regular exercise, avoiding tobacco and alcohol, and good sleep-can help delay dependence, lower the risk of chronic disease, and improve well-being. To promote these habits, social innovation must generate new services and approaches that address real needs, barriers, and motivations in adopting healthier lifestyles.
Read more
Our group's research shows that participatory science is an effective tool to promote healthy ageing in rural settings. A three-month intervention co-designed with older adults in villages of ≤2,000 inhabitants led to improvements in locomotor function, measured through sarcopenia parameters, and enhanced quality of life in areas such as vitality, mental health, and social functioning. A distinctive feature of this approach is shared decision-making between residents and policymakers, ensuring that solutions are adapted to local realities. This fosters greater adherence, empowerment, and long-term sustainability of co-created strategies.
This project is directly relevant to public policy through collaboration with the Consell Comarcal del Priorat, which represents 23 municipalities. Their recent report identified ageing as a major concern for both institutions and residents. The project's results can therefore guide health policies-decisions, plans, and actions-that address local needs while considering available resources and ensuring long-term sustainability.
By focusing on health promotion and disease prevention, the project ensures that policies are evidence-based and subject to evaluation. The partnership with the Consell Comarcal also aligns with Sustainable Development Goal 3 (Health and Well-being) of the 2030 WHO Agenda and supports the "Health in All Policies" approach, fostering integrated strategies across sectors.
The principal aim of the study is to evaluate the effectiveness of a participatory science intervention study in improving lifestyle habits (dietary habits, physical activity, substance use, and sleep quality), quality of life, emotional well-being, and locomotor capacities through the assessment of sarcopenia parameters (muscle strength, muscle mass, and physical function) in young-old adults (≥60 years) living in rural areas of the Priorat region (Catalonia, Spain).
Specific Objectives:
- To describe the health status of older people residing in the Priorat region by evaluating: lifestyle habits (diet, substance use, physical activity, and sleep), risk of malnutrition, functional capacity based on sarcopenia parameters, mental capacity (mental health and emotional well-being), and quality of life.
- To improve lifestyle habits (diet, physical activity, sedentary behaviour, sleep habits, and substance use-alcohol and smoking), emotional well-being and personal relationships to avoid unwanted loneliness, quality of life, and locomotor abilities based on sarcopenia parameters (muscle strength, muscle mass, and physical function).
- To reduce the risk of malnutrition.
- To compare the health status of two groups: those aged 60-74 (young-old adults) and those aged 75 and over (older people).
- To identify the needs, barriers, and motivations of older people through focus groups, including participants aged 60-74, those over 75, and stakeholders such as members of the public administration supporting the project.
- To compare the differences in needs, barriers, and motivations identified by the young-old adults (60-74 years) and the older people (≥75 years).
- To actively involve older participants in the co-creation of health promotion activities and an intervention designed for them and their peers.
- To implement an intervention based on proposals generated during the co-creation process to improve their lifestyle (dietary habits, physical activity, substance use, well-being, and sleep behaviours), quality of life, and locomotor abilities.
- To analyse environmental barriers, using the "Age-Friendly Cities and Communities Questionnaire (AFCCQ)", in the villages of the Priorat region that may influence the ability to maintain a healthy lifestyle and quality of life for people aged 60-74 and those aged 75 and over.
Read the detailed description
The study will last for 24 months and will be structured into various tasks:
Tasks 1 and 2. Recruitment of villages and participants
- Villages: In collaboration with the Consell Comarcal del Priorat, the strategy for contacting the villages will be decided, whether through local councils, community centres, elderly associations, etc. Dissemination may be carried out through posters, social media, letters to residents, electronic bulletins (e-bando), etc. The villages in the Priorat region interested in participating will be randomly assigned into two groups: control group (at least 5 villages with 8 participants each) and intervention group (at least 5 villages with 8 participants each).
- Participants:
- Older adults (both young-old and elderly) who choose to take part in the project will sign an informed consent form.
- Stakeholders from the quadruple helix model: companies, government officials, academic institutions, and the community members who may influence the lifestyles of older adults (both young-old adults and elderly) in the rural Priorat region will be contacted by phone or email and informed about the project. Stakeholders will also sign an informed consent form.
Task 3. Characterisation of participants Questionnaires about lifestyles and anthropometric measurements will be completed in small sessions, individually, in person, and on paper. Also, focus groups will be done to gather insights into participants' perceptions of ageing, their needs, barriers, and motivations to improve and maintain healthy lifestyles. Three separate focus groups will be conducted with: young-old adults (60-74 years), elderly adults (≥75 years), and stakeholders, each consisting of 6-8 participants.
Focus groups are structured, moderated group discussions where participants are encouraged to freely express their opinions in response to specific questions. Each session will last approximately 75 minutes and be led by an external moderator.
Baseline data (questionnaires and focus group data) will be analyzed to prepare the co-creation process, ensuring that it is adapted to the real needs and characteristics of the population.
Task 4. Co-creation of solutions Based on the information gathered during the initial characterisation (baseline assessments and focus groups), solutions will be developed through a co-creation process involving older participants (young-old and elderly) from the intervention groups and the stakeholders.
The co-creation session (lasting 4 hours) will follow the PRODUCES framework: a) Problem: Unhealthy lifestyles among people aged ≥ 60 years old, b) Objective: To design solutions to improve lifestyles of people aged ≥ 60 years old, c) Design: Participatory research to increase individual empowerment, d) Users: People aged ≥ 60 years old, e) Co-creators: Stakeholders and older adults, f) Evaluation: Through comparison of intervention and control group, g) Scalability: Model generalisable to other similar areas with elderly populations.
The co-creation process is structured as follows: a) Co-ideation: Word Café dynamics, b) Co-design of the most voted ideas, c) Collaborative prototyping and testing. After sharing ideas, activities, events, dissemination materials, and any other elements deemed necessary to address identified barriers and needs related to lifestyle will be designed.
Proposed activities that provide solutions and fall within the project's budget (agreed upon with the Consell Comarcal del Priorat to ensure sustainability) will be presented and discussed among participants. Finally, participants will take part in prioritizing proposals and defining the final solutions to be implemented."
Task 5. Implementation of the intervention in the intervention villages The co-created intervention for older adults (young-old and elderly) in Priorat villages will be implemented in IG village over 6 months.
Once the intervention has been implemented in intervention villages, the same will be offered to control villages, but without further evaluation, to avoid bias and ensure fair access to potential benefits.
Task 6. Participant characterization (younger-old and older-old) - final assessment: Both participants who received the intervention and those in the control group will be evaluated by questionnaires about lifestyles and anthropometric measurements, to compare any differences between those who underwent the intervention and those who did not.
- Conditions
- Healthy Lifestyle
- Being tested
- Co-created intervention
- Keywords
- Participatory research, healthy lifestyle, quality of life, older adults, rural environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-created interventionBehavioural
Intervention generated by a participatory research process (co-creation) in the elderly population living in rural areas to co-create solutions to improve their lifestyles, quality of life and health.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receive the co-created intervention Receives: Behavioral: Co-created intervention |
| Control | No intervention | still with their habitual lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional intake
The Food Frequency Consumption Questionnaire (FFCQ) (Rodríguez IT, et al. Nutr Hosp. 2008) to assess the nutritional intake of elderly participants.
Measured: Baseline and follow-up (6 months later)
Physical activity and sedentary behaviour
International physical activity questionnaire for elderly: IPAQ for elderly IPAQ-E, Spanish version (Rubio-Castañeda et al., 2017). Higher scores mean a better outcome.
Measured: Baseline and follow-up (6 months later)
Sleep quality
Pittsburgh questionnaire (Buysse et al., 1989). The maximum score is 21 points. More than 5 points are considered bad outcomes and sleep problems, and less than 5 points are considered better outcomes and no sleep problems.
Measured: Baseline and follow-up (6 months later)
Depressive symptoms
Geriatric Depression Scale Questionnaire (Yesavage et al., 1983). The maximum punctuation is 15. The score is 0-4, no depression; 5-8, mild depression; 9-11, moderate depression; and 12-15, severe depression.
Measured: Baseline and follow-up (6 months later)
Quality of life behaviours
Quality of life assessed by the SF-36 Health survey questionnaire (Ware \& Sherbourne, 1992) and the EuroQol-5D questionnaire (Herdman M et al., 2001). Higher scores mean a better outcome.
Measured: Baseline and follow-up (6 months later)
Muscle strength
The muscle strength assessed by handgrip dynamometry (Jamar dynamometer; Sammons Preston Rolyan, Bolingbrook, IL).
Measured: Baseline and follow-up (6 months later)
Muscle mass
Muscle mass (appendicular skeletal muscle mass (kg)) assessed by Bioimpedance TANITA (MC-780MA; Tanita Corp., Tokyo, Japan).
Measured: Baseline and follow-up (6 months later)
Physical performance
Gait speed (m/s) assessed by the length of the walking course divided by the time (Ladang et al., 2023).
Measured: Baseline and follow-up (6 months later)
Nutritional status
Hemoglobin (g/dl) in blood samples assessed by HemoCue® Hb 801 (HemoCue AB, Ängelholm, Suecia, 2020).
Measured: Baseline and follow-up (6 months later)
Secondary outcomes (20)
Nutritional status
Mini Nutritional Assessment Short-Form (MNA-SF). The maximum punctuation is 14 points. The score is 0-7 points (malnutrition), 8-11 points (risk of malnutrition), and 12-14 points (normal nutritional status).
Measured: Baseline and follow-up (6 months later)
Anthropometric measures
Height (cm) measured by wall-mounted stadiometer (Tanita Leicester Portable; Tanita Corp., Barcelona, Spain)
Measured: Baseline and follow-up (6 months later)
Anthropometric measures
Weight (kg) measured by calibrated scale (TANITA MC-780MA; Tanita Corp., Tokyo, Japan).
Measured: Baseline and follow-up (6 months later)
Anthropometric measures
BMI (kg/m2) is calculated by dividing weight (kg) by height (m2).
Measured: Baseline and follow-up (6 months later)
Anthropometric measures
WC: waist circumference (cm) measured by steel measuring tape (at the umbilicus).
Measured: Baseline and follow-up (6 months later)
Anthropometric measures
Calf circumference(cm) measured by steel measuring tape.
Measured: Baseline and follow-up (6 months later)
Vascular parameters
Systolic and diastolic blood pressure (SBP and DBP) (mm Hg) and pulse pressure (PP) (mm Hg) assessed by an automatic sphygmomanometer (OMRON HEM-907; Peroxfarma, Barcelona, Spain).
Measured: Baseline and follow-up (6 months later)
Muscle mass
Muscle mass thickness of quadriceps and forearm assessed by ultrasound (VINNO 5 (Vinno (Suzhou) Co., Ltd., China)
Measured: Baseline and follow-up (6 months later)
Abdominal fat
Abdominal fat assessed by ultrasound (VINNO 5 (Vinno (Suzhou) Co., Ltd., China)
Measured: Baseline and follow-up (6 months later)
Healthy and friendly communities
Age-Friendly Cities and Communities Questionnaire (AFCCQ) with eight domains (housing, social participation, respect and social inclusion, civic participation and employment, communication and information, community support and health services, outdoor spaces and buildings, transportation, financial situation). All domains are answered on a 5-point scale, ranging from totally disagree to totally agree. Scores: -2 = totally disagree; -1 = disagree; 0 = neutral; 1 = agree; 2 = totally agree. Higher scores in each domain mean a better outcome.
Measured: Baseline and follow-up (6 months later)
Socio-familiar situation
Socio-familiar situation assessed through the validated questionnaire Socio-Familial Assessment Scale (TSO) (Giménez Bertomeu VM, et al. 2020), based on different indicators (family structure and function, social contacts, required support, and receipt of resources for activities of daily living, economic income, and housing).
Measured: Baseline and follow-up (6 months later)
Other health determinants
Other health determinants that participants considered important to address, selected during the focus groups.
Measured: Baseline and follow-up (6 months later)
Lipid profile
Total cholesterol (mmol/L) in blood samples assessed by Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
Measured: Baseline and follow-up (6 months later)
Lipid profile
HDLc (mmol/L) in blood samples assessed by Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
Measured: Baseline and follow-up (6 months later)
Lipid profile
LDLc (mmol/L) in blood samples assessed by Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
Measured: Baseline and follow-up (6 months later)
Lipid profile
Total TG (mmol/L) in blood samples assessed by Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
Measured: Baseline and follow-up (6 months later)
Glucose homeostasis
Fasting blood glucose (mmol/L)in blood samples assessed by OneTouch Select Plus Flex®.
Measured: Baseline and follow-up (6 months later)
Glucose homeostasis
HGBA1c (%) in blood samples assessed by Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
Measured: Baseline and follow-up (6 months later)
Inflamation markers
High-sensitivity C-reactive protein (mg/dL) in blood samples assessed by Cobas Mira Plus autoanalyzer (Roche Diagnostics Systems, Madrid, Spain).
Measured: Baseline and follow-up (6 months later)
Urine metabolites
Metabolomic characterization: targeted metabolomics for the detection of over 1,000 metabolites. Targeted metabolomic analysis is performed using a liquid chromatography-tandem mass spectrometry (LC-MS/MS) platform, employing multiple reaction monitoring (MRM) in both positive and negative ionization modes. The protocol includes a prior chemical derivatization step, followed by separation via reversed-phase liquid chromatography (RP-LC) and/or direct flow injection to the mass spectrometer (DFI-MS) for the analysis of the target metabolites. Quantification is carried out using internal isotopic standards and multipoint calibration curves, allowing for absolute concentration determination. (Zheng J, et al. Anal Chem. 2020; 92(15):10664-70/ Zhang L, et al. Metabolites. 2024;14(11):622)
Measured: Baseline and follow-up (6 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start6 Oct 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: receive the co-created intervention Control group: still with habitual lifestyle.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Consell Comarcal del Priorat, Fundación para la Ciencia y la Tecnología
- Responsible party
- Principal investigator, Elisabet Llauradó, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07189533
- Sponsor's protocol ID
- 010/2025
- Other IDs
- FCT-24-19957
- Acronym
- SENPRI
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SENior PRIorat: Ciencia Participativa Para la Mejora de Los Estilos de Vida, la Calidad de Vida, el Bienestar Emocional y Las Capacidades Locomotoras de Las Personas Mayores Del Priorat
- ClinicalTrials.gov ID
- NCT07189533
- Acronym / sponsor ID
- SENPRI / 010/2025
- Conditions
- Healthy Lifestyle
- Keywords
- Participatory research, healthy lifestyle, quality of life, older adults, rural environment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Consell Comarcal del Priorat, Fundación para la Ciencia y la Tecnología
- Study start
- 6 Oct 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spain is experiencing a demographic shift towards an ageing population. In 2022, 20.1% of Spaniards were 65 or older, a figure projected to reach 30.4% by 2050. The trend is especially marked in rural areas, where outmigration of younger generations has left a high concentration of older residents. In Catalonia's Priorat county, the share of people aged 65+ already exceeds 20%, reaching 30%, and even 40% in some villages.
The ageing process brings biological changes that reduce locomotor and cognitive abilities, limiting autonomy and quality of life. In rural areas, these challenges are compounded by social isolation and the lack of support networks, making older adults more vulnerable. Healthy lifestyle habits-such as balanced nutrition, regular exercise, avoiding tobacco and alcohol, and good sleep-can help delay dependence, lower the risk of chronic disease, and improve well-being. To promote these habits, social innovation must generate new services and approaches that address real needs, barriers, and motivations in adopting healthier lifestyles.
Our group's research shows that participatory science is an effective tool to promote healthy ageing in rural settings. A three-month intervention co-designed with older adults in villages of ≤2,000 inhabitants led to improvements in locomotor function, measured through sarcopenia parameters, and enhanced quality of life in areas such as vitality, mental health, and social functioning. A distinctive feature of this approach is shared decision-making between residents and policymakers, ensuring that solutions are adapted to local realities. This fosters greater adherence, empowerment, and long-term sustainability of co-created strategies.
This project is directly relevant to public policy through collaboration with the Consell Comarcal del Priorat, which represents 23 municipalities. Their recent report identified ageing as a major concern for both institutions and residents. The project's results can therefore guide health policies-decisions, plans, and actions-that address local needs while considering available resources and ensuring long-term sustainability.
By focusing on health promotion and disease prevention, the project ensures that policies are evidence-based and subject to evaluation. The partnership with the Consell Comarcal also aligns with Sustainable Development Goal 3 (Health and Well-being) of the 2030 WHO Agenda and supports the "Health in All Policies" approach, fostering integrated strategies across sectors.
The principal aim of the study is to evaluate the effectiveness of a participatory science intervention study in improving lifestyle habits (dietary habits, physical activity, substance use, and sleep quality), quality of life, emotional well-being, and locomotor capacities through the assessment of sarcopenia parameters (muscle strength, muscle mass, and physical function) in young-old adults (≥60 years) living in rural areas of the Priorat region (Catalonia, Spain).
Specific Objectives:
- To describe the health status of older people residing in the Priorat region by evaluating: lifestyle habits (diet, substance use, physical activity, and sleep), risk of malnutrition, functional capacity based on sarcopenia parameters, mental capacity (mental health and emotional well-being), and quality of life.
- To improve lifestyle habits (diet, physical activity, sedentary behaviour, sleep habits, and substance use-alcohol and smoking), emotional well-being and personal relationships to avoid unwanted loneliness, quality of life, and locomotor abilities based on sarcopenia parameters (muscle strength, muscle mass, and physical function).
- To reduce the risk of malnutrition.
- To compare the health status of two groups: those aged 60-74 (young-old adults) and those aged 75 and over (older people).
- To identify the needs, barriers, and motivations of older people through focus groups, including participants aged 60-74, those over 75, and stakeholders such as members of the public administration supporting the project.
- To compare the differences in needs, barriers, and motivations identified by the young-old adults (60-74 years) and the older people (≥75 years).
- To actively involve older participants in the co-creation of health promotion activities and an intervention designed for them and their peers.
- To implement an intervention based on proposals generated during the co-creation process to improve their lifestyle (dietary habits, physical activity, substance use, well-being, and sleep behaviours), quality of life, and locomotor abilities.
- To analyse environmental barriers, using the "Age-Friendly Cities and Communities Questionnaire (AFCCQ)", in the villages of the Priorat region that may influence the ability to maintain a healthy lifestyle and quality of life for people aged 60-74 and those aged 75 and over.
Detailed description
The study will last for 24 months and will be structured into various tasks:
Tasks 1 and 2. Recruitment of villages and participants
- Villages: In collaboration with the Consell Comarcal del Priorat, the strategy for contacting the villages will be decided, whether through local councils, community centres, elderly associations, etc. Dissemination may be carried out through posters, social media, letters to residents, electronic bulletins (e-bando), etc. The villages in the Priorat region interested in participating will be randomly assigned into two groups: control group (at least 5 villages with 8 participants each) and intervention group (at least 5 villages with 8 participants each).
- Participants:
- Older adults (both young-old and elderly) who choose to take part in the project will sign an informed consent form.
- Stakeholders from the quadruple helix model: companies, government officials, academic institutions, and the community members who may influence the lifestyles of older adults (both young-old adults and elderly) in the rural Priorat region will be contacted by phone or email and informed about the project. Stakeholders will also sign an informed consent form.
Task 3. Characterisation of participants Questionnaires about lifestyles and anthropometric measurements will be completed in small sessions, individually, in person, and on paper. Also, focus groups will be done to gather insights into participants' perceptions of ageing, their needs, barriers, and motivations to improve and maintain healthy lifestyles. Three separate focus groups will be conducted with: young-old adults (60-74 years), elderly adults (≥75 years), and stakeholders, each consisting of 6-8 participants.
Focus groups are structured, moderated group discussions where participants are encouraged to freely express their opinions in response to specific questions. Each session will last approximately 75 minutes and be led by an external moderator.
Baseline data (questionnaires and focus group data) will be analyzed to prepare the co-creation process, ensuring that it is adapted to the real needs and characteristics of the population.
Task 4. Co-creation of solutions Based on the information gathered during the initial characterisation (baseline assessments and focus groups), solutions will be developed through a co-creation process involving older participants (young-old and elderly) from the intervention groups and the stakeholders.
The co-creation session (lasting 4 hours) will follow the PRODUCES framework: a) Problem: Unhealthy lifestyles among people aged ≥ 60 years old, b) Objective: To design solutions to improve lifestyles of people aged ≥ 60 years old, c) Design: Participatory research to increase individual empowerment, d) Users: People aged ≥ 60 years old, e) Co-creators: Stakeholders and older adults, f) Evaluation: Through comparison of intervention and control group, g) Scalability: Model generalisable to other similar areas with elderly populations.
The co-creation process is structured as follows: a) Co-ideation: Word Café dynamics, b) Co-design of the most voted ideas, c) Collaborative prototyping and testing. After sharing ideas, activities, events, dissemination materials, and any other elements deemed necessary to address identified barriers and needs related to lifestyle will be designed.
Proposed activities that provide solutions and fall within the project's budget (agreed upon with the Consell Comarcal del Priorat to ensure sustainability) will be presented and discussed among participants. Finally, participants will take part in prioritizing proposals and defining the final solutions to be implemented."
Task 5. Implementation of the intervention in the intervention villages The co-created intervention for older adults (young-old and elderly) in Priorat villages will be implemented in IG village over 6 months.
Once the intervention has been implemented in intervention villages, the same will be offered to control villages, but without further evaluation, to avoid bias and ensure fair access to potential benefits.
Task 6. Participant characterization (younger-old and older-old) - final assessment: Both participants who received the intervention and those in the control group will be evaluated by questionnaires about lifestyles and anthropometric measurements, to compare any differences between those who underwent the intervention and those who did not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group: receive the co-created intervention Control group: still with habitual lifestyle.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Co-created interventionReceive the co-created intervention |
| Control | No intervention | –still with their habitual lifestyle |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 60 years or older
- Signed informed consent
- Living independently
- Capacity to follow and complete the study
- Resident in one of the villages of the Priorat region
Key exclusion criteria (1 listed)
- Failure to meet any of the inclusion criteria will be considered grounds for exclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-created interventionIntervention generated by a participatory research process (co-creation) in the elderly population living in rural areas to co-create solutions to improve their lifestyles, quality of life and health. | Behavioural | Intervention |
Primary outcome
Nutritional intake
Time frame: Baseline and follow-up (6 months later)
The Food Frequency Consumption Questionnaire (FFCQ) (Rodríguez IT, et al. Nutr Hosp. 2008) to assess the nutritional intake of elderly participants.
Physical activity and sedentary behaviour
Time frame: Baseline and follow-up (6 months later)
International physical activity questionnaire for elderly: IPAQ for elderly IPAQ-E, Spanish version (Rubio-Castañeda et al., 2017). Higher scores mean a better outcome.
Sleep quality
Time frame: Baseline and follow-up (6 months later)
Pittsburgh questionnaire (Buysse et al., 1989). The maximum score is 21 points. More than 5 points are considered bad outcomes and sleep problems, and less than 5 points are considered better outcomes and no sleep problems.
Depressive symptoms
Time frame: Baseline and follow-up (6 months later)
Geriatric Depression Scale Questionnaire (Yesavage et al., 1983). The maximum punctuation is 15. The score is 0-4, no depression; 5-8, mild depression; 9-11, moderate depression; and 12-15, severe depression.
Quality of life behaviours
Time frame: Baseline and follow-up (6 months later)
Quality of life assessed by the SF-36 Health survey questionnaire (Ware \& Sherbourne, 1992) and the EuroQol-5D questionnaire (Herdman M et al., 2001). Higher scores mean a better outcome.
Muscle strength
Time frame: Baseline and follow-up (6 months later)
The muscle strength assessed by handgrip dynamometry (Jamar dynamometer; Sammons Preston Rolyan, Bolingbrook, IL).
Muscle mass
Time frame: Baseline and follow-up (6 months later)
Muscle mass (appendicular skeletal muscle mass (kg)) assessed by Bioimpedance TANITA (MC-780MA; Tanita Corp., Tokyo, Japan).
Physical performance
Time frame: Baseline and follow-up (6 months later)
Gait speed (m/s) assessed by the length of the walking course divided by the time (Ladang et al., 2023).
Nutritional status
Time frame: Baseline and follow-up (6 months later)
Hemoglobin (g/dl) in blood samples assessed by HemoCue® Hb 801 (HemoCue AB, Ängelholm, Suecia, 2020).
20 secondary outcomes
Nutritional status
Time frame: Baseline and follow-up (6 months later)
Anthropometric measures
Time frame: Baseline and follow-up (6 months later)
Anthropometric measures
Time frame: Baseline and follow-up (6 months later)
Anthropometric measures
Time frame: Baseline and follow-up (6 months later)
Anthropometric measures
Time frame: Baseline and follow-up (6 months later)
Anthropometric measures
Time frame: Baseline and follow-up (6 months later)
Vascular parameters
Time frame: Baseline and follow-up (6 months later)
Muscle mass
Time frame: Baseline and follow-up (6 months later)
Abdominal fat
Time frame: Baseline and follow-up (6 months later)
Healthy and friendly communities
Time frame: Baseline and follow-up (6 months later)
Socio-familiar situation
Time frame: Baseline and follow-up (6 months later)
Other health determinants
Time frame: Baseline and follow-up (6 months later)
Lipid profile
Time frame: Baseline and follow-up (6 months later)
Lipid profile
Time frame: Baseline and follow-up (6 months later)
Lipid profile
Time frame: Baseline and follow-up (6 months later)
Lipid profile
Time frame: Baseline and follow-up (6 months later)
Glucose homeostasis
Time frame: Baseline and follow-up (6 months later)
Glucose homeostasis
Time frame: Baseline and follow-up (6 months later)
Inflamation markers
Time frame: Baseline and follow-up (6 months later)
Urine metabolites
Time frame: Baseline and follow-up (6 months later)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-created intervention in people with Healthy Lifestyle, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabet Llauradó, PhD (+34977759375 ext. 9375, elisabet.llaurado@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional intake (time frame: Baseline and follow-up (6 months later)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.