Earlier Elderly People in Urban Areas

Sponsor
University Rovira i Virgili (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05268146
Collaborator
(none)
77
2
1.9
38.5
20.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lifestyles

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
77 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Urban Areas
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Mar 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Risk of sarcopenia (muscle strength) [1 day]

    Reduction of muscle strength: <27kg in men and <16kg in women measured by a dynamometer

  2. Diagnosis of sarcopenia (muscle strength) [1 day]

    Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)

  3. Diagnosis of sarcopenia (muscle mass) [1 day]

    Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)

  4. Diagnosis of severe sarcopenia (muscle strength) [1 day]

    Reduction of muscle strength (<27kg in men and <16kg in women measured by a dynamometer) and

  5. Diagnosis of severe sarcopenia (muscle mass) [1 day]

    Reduction of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)

  6. Diagnosis of severe sarcopenia (muscle function) [1 day]

    Reduction of muscle function (≤0.8 m / s)

Secondary Outcome Measures

  1. Nutrition [1 day]

    Food frequency questionnaire (not scale)

  2. Physical activity [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).

  3. Sleep behaviour [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.

  4. Risk of malnutrition [1 day]

    Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition

  5. Weight [1 day]

    Weight using a balance (kg)

  6. height [1 day]

    Height using a tallimeter (m)

  7. BMI [1 day]

    Using weight (kg) / height (m)2

Other Outcome Measures

  1. Age [1 day]

    Age in years

  2. Gender [1 day]

    Female or male

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 74 Years
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut d'Investigació Sanitaria Pere i Virgili Reus Tarragona Spain 43204
2 University Rovira i Virgili Reus Tarragona Spain

Sponsors and Collaborators

  • University Rovira i Virgili

Investigators

  • Principal Investigator: Rosa Sola, Dr, Universitat Rovira i Virgili

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rosa Sola, Full Professor, Dr., University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT05268146
Other Study ID Numbers:
  • Earlier-Elderly Urban People
First Posted:
Mar 7, 2022
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022