Earlier Elderly People in Rural Areas

NCT05273502 | Unknown DMC

• 1 other identifier: Earlier-Elderly Rural People
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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. Older people living in rural 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 rural areas in the generation of solutions, which will make these solutions especially adapted to their needs. It also aims to study the effectiveness of a health education intervention based on participatory research, where young seniors co-create and implement the intervention among their peers, and focused on improving lifestyles, to prevent or to improve sarcopenia. The objectives of this project are: To characterize the elderly (60 to 74 years) who live independently in rural 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 group interviews (focus groups) including earlier elderly people from rural areas. In addition, participants will receive the intervention co-created by themselves, and the effectiveness of the intervention created will be evaluated.

Conditions

Health Behavior; Sarcopenia; Nutrition; Sleep; Physical Activity; Lifestyle, Healthy

Outcome Measures

Primary Outcomes (6)

• Risk of sarcopenia (muscle strength)

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

  Baseline and through study completion, an average of 1 year

• Diagnosis of sarcopenia (muscle strength)

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

  Baseline and through study completion, an average of 1 year

• Diagnosis of sarcopenia (muscle mass)

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

  Baseline and through study completion, an average of 1 year

• Diagnosis of severe sarcopenia (muscle strength)

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

  Baseline and through study completion, an average of 1 year

• Diagnosis of severe sarcopenia (muscle mass)

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

  Baseline and through study completion, an average of 1 year

• Diagnosis of severe sarcopenia (muscle function)

  Change of muscle function (≤0.8 m / s)

  Baseline and through study completion, an average of 1 year

Secondary Outcomes (6)

• Nutrition

  Baseline and through study completion, an average of 1 year

• Physical activity

  Baseline and through study completion, an average of 1 year

• Sleep behaviour

  Baseline and through study completion, an average of 1 year

• Risk of malnutrition

  Baseline and through study completion, an average of 1 year

• Weight

  Baseline and through study completion, an average of 1 year

Other Outcomes (2)

• Age

  Baseline and through study completion, an average of 1 year

• Gender

  Baseline

Study Arms (2)

Citizen Science Behavioral Intervention

EXPERIMENTAL

The intervention group (IG) participants will receive the whole citizen science intervention of the project, and participants will be assessed at baseline and end-of-study.

Behavioral: Citizen Science intervention

Control group

NO INTERVENTION

The controls group (CG) participants will not receive any kind of intervention, and participants will only be assessed at baseline and end-of-study.

Interventions

Citizen Science intervention BEHAVIORAL

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.

Citizen Science Behavioral Intervention

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People ≥60 years and ≤74 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.

Sponsors & Collaborators

• University Rovira i Virgili: lead

Study Sites (1)

University Rovira i Virgili

Reus, Tarragona, Spain

RECRUITING

MeSH Terms

Conditions

Health Behavior; Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Rosa Solà, Dr

CONTACT

0034 977759369; rosa.sola@urv.cat

Lucia Tarro, Dr

CONTACT

0034 977758920; lucia.tarro@urv.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an educational program, so that, the intervention group will know that will receive some educational and behavioral activities, and the control group will know that they will not receive any kind of activities.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Full professor

Model Details: Randomized Controlled Trial (cluster)

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 10, 2022
• Study Start: March 1, 2022
• Primary Completion: May 15, 2022
• Study Completion: December 30, 2023
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)