- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05268146
Earlier Elderly People in Urban Areas
Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Urban Areas
Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050.
The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in urban areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.
To achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition, and sarcopenia), and conduct focus groups including young seniors from urban areas, and stakeholders, to determine their needs, interests, and barriers for pursuing healthy lifestyles. Based on the information obtained in the diagnosis and focus groups, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Social innovation in aging needs to bring new ideas and services to meet new social and welfare needs identified in recent years. In our environment, people ≥60 years old accounted for 20% -24% of the population in 2015, and it is expected to increase to ≥30% by 2050. For the first time in history, most people can aspire to live well beyond the age of 60. On the other hand, the Covid-19 pandemic has severely affected people ≥60 years of age and may make the welfare and health problems of this population more evident, such as unhealthy lifestyles, the risk of malnutrition, and sarcopenia (defined as loss of muscle mass, strength, and function), which leads to significant dependency and quality of life problems. In addition, older people living in urban areas have been severely affected by confinement, and new needs are being generated. To better understand the needs, an innovative element of this project is to involve the elderly-young people (60-74 years) from urban areas in the generation of solutions, which will make these solutions especially adapted to their needs. Therefore increase the adherence to the solutions created, and also the long-term sustainability of the solutions.
The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in urban areas of the province of Tarragona, to actively involve them, through a process of participatory research to generate solutions.
To achieve this goal, it is proposed to make a diagnosis of their health status (lifestyles, risk of malnutrition, and sarcopenia), and conduct focus groups including young seniors from urban areas, and stakeholders, to determine their needs, interests, and barriers for pursuing healthy lifestyles. Based on the information obtained in the diagnosis and focus groups, there will be processes for co-creating solutions based on proposed activities or changes in their immediate environment. During the co-creation process, the elderly and the 4-helix stakeholders (government, industry, university, and civil society) will be involved.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Tarragona
-
Reus, Tarragona, Spain
- University Rovira i Virgili
-
Reus, Tarragona, Spain, 43204
- Institut d'Investigació Sanitaria Pere i Virgili
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- People ≥60 years and ≤75 years,
- That they have informed consent,
- Living at home (living independently), Community-dwelling early-elderly
- That they can continue the study,
- They live in the province of Tarragona
Exclusion Criteria:
- Failure to comply with the inclusion criteria will be considered an exclusion criterion.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk of sarcopenia (muscle strength)
Time Frame: 1 day
|
Reduction of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
|
1 day
|
|
Diagnosis of sarcopenia (muscle strength)
Time Frame: 1 day
|
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
|
1 day
|
|
Diagnosis of sarcopenia (muscle mass)
Time Frame: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle strength)
Time Frame: 1 day
|
Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer) and
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle mass)
Time Frame: 1 day
|
Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
|
1 day
|
|
Diagnosis of severe sarcopenia (muscle function)
Time Frame: 1 day
|
Reduction of muscle function (≤0.8 m / s)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nutrition
Time Frame: 1 day
|
Food frequency questionnaire (not scale) |
1 day
|
|
Physical activity
Time Frame: 1 day
|
International physical activity questionnaire for elderly Low category: non-physical activity or it is not enough to achieve moderate or high category Moderate category: 3 or more days / weeks (vigorous physical activity, at least 25 minutes/day), or 5 or more (moderate physical activity, at least 30 minutes/day), or 5 or more days / weeks of a combination of walking, or moderate-vigorous physical activity (at least 600 METS). High category: 7 or more days / week of a combination of walking, or moderate-vigorous physical activity (at least 3000 METS). |
1 day
|
|
Sleep behaviour
Time Frame: 1 day
|
Pittsburg questionnaire Pittsburg questionnaire The questionnaire contains a total of 19 questions, grouped into 10 questions. The 19 questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates severe difficulty, within their respective area. The score of the seven areas is finally added to give an overall score, which ranges from 0 to 21 points. "0" indicates ease of sleeping and "21" severe difficulty in all areas. |
1 day
|
|
Risk of malnutrition
Time Frame: 1 day
|
Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition
|
1 day
|
|
Weight
Time Frame: 1 day
|
Weight using a balance (kg)
|
1 day
|
|
height
Time Frame: 1 day
|
Height using a tallimeter (m)
|
1 day
|
|
BMI
Time Frame: 1 day
|
Using weight (kg) / height (m)2
|
1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: 1 day
|
Age in years
|
1 day
|
|
Gender
Time Frame: 1 day
|
Female or male
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rosa Sola, Dr, University Rovira i Virgili
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Earlier-Elderly Urban People
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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