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临床试验/NCT07189533
NCT07189533尚未招募不适用

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

University Rovira i Virgili2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
2
主要终点
Nutritional intake

研究概览

简要总结

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:

  1. 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.
  2. 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).
  3. To reduce the risk of malnutrition.
  4. To compare the health status of two groups: those aged 60-74 (young-old adults) and those aged 75 and over (older people).
  5. 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.
  6. To compare the differences in needs, barriers, and motivations identified by the young-old adults (60-74 years) and the older people (≥75 years).
  7. To actively involve older participants in the co-creation of health promotion activities and an intervention designed for them and their peers.
  8. 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.
  9. 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.

详细描述

The study will last for 24 months and will be structured into various tasks:

Tasks 1 and 2. Recruitment of villages and participants

  1. 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). 2. 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The allocation will not be blinded due to the nature of the intervention.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Failure to meet any of the inclusion criteria will be considered grounds for exclusion.

结局指标

主要结局

Nutritional intake

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Baseline and follow-up (6 months later)

The muscle strength assessed by handgrip dynamometry (Jamar dynamometer; Sammons Preston Rolyan, Bolingbrook, IL).

Muscle mass

时间窗: 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

时间窗: 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

时间窗: Baseline and follow-up (6 months later)

Hemoglobin (g/dl) in blood samples assessed by HemoCue® Hb 801 (HemoCue AB, Ängelholm, Suecia, 2020).

次要结局

  • Anthropometric measures(Baseline and follow-up (6 months later))
  • Nutritional status(Baseline and follow-up (6 months later))
  • Vascular parameters(Baseline and follow-up (6 months later))
  • Muscle mass(Baseline and follow-up (6 months later))
  • Abdominal fat(Baseline and follow-up (6 months later))
  • Healthy and friendly communities(Baseline and follow-up (6 months later))
  • Socio-familiar situation(Baseline and follow-up (6 months later))
  • Other health determinants(Baseline and follow-up (6 months later))
  • Glucose homeostasis(Baseline and follow-up (6 months later))
  • Inflamation markers(Baseline and follow-up (6 months later))
  • Urine metabolites(Baseline and follow-up (6 months later))
  • Lipid profile(Baseline and follow-up (6 months later))

研究者

发起方
University Rovira i Virgili
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisabet Llauradó

Doctor, Lecturer

University Rovira i Virgili

研究点 (2)

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