NCT05268146

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 7, 2022

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

February 11, 2022

Last Update Submit

March 15, 2022

Conditions

SarcopeniaEldery PeopleLifestyle, HealthyNutritionSleepPhysical ActivityParticipatory Research

Outcome Measures

Primary Outcomes (6)

  • Risk of sarcopenia (muscle strength)

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

    1 day

  • Diagnosis of sarcopenia (muscle strength)

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

    1 day

  • Diagnosis of sarcopenia (muscle mass)

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

    1 day

  • Diagnosis of severe sarcopenia (muscle strength)

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

    1 day

  • Diagnosis of severe sarcopenia (muscle mass)

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

    1 day

  • Diagnosis of severe sarcopenia (muscle function)

    Reduction of muscle function (≤0.8 m / s)

    1 day

Secondary Outcomes (7)

  • Nutrition

    1 day

  • Physical activity

    1 day

  • Sleep behaviour

    1 day

  • Risk of malnutrition

    1 day

  • Weight

    1 day

  • +2 more secondary outcomes

Other Outcomes (2)

  • Age

    1 day

  • Gender

    1 day

Interventions

LifestylesBEHAVIORAL

Co-creation process and participatory research; lifestyles

Eligibility Criteria

Age60 Years - 74 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Earlier elderly people living in urban areas. The target population will be recruited from different places in the community, town halls, civic centers, senior citizens' associations, etc.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut d'Investigació Sanitaria Pere i Virgili

Reus, Tarragona, 43204, Spain

Location

University Rovira i Virgili

Reus, Tarragona, Spain

Location

MeSH Terms

Conditions

SarcopeniaMotor Activity

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Study Officials

  • Rosa Sola, Dr

    University Rovira i Virgili

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor, Dr.

Study Record Dates

First Submitted

February 11, 2022

First Posted

March 7, 2022

Study Start

February 1, 2022

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)