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Earlier Elderly People in Rural Areas

Primary Purpose

Health Behavior, Sarcopenia, Nutrition

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Citizen Science intervention
Sponsored by
University Rovira i Virgili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Health Behavior

Eligibility Criteria

60 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Failure to comply with the inclusion criteria will be considered an exclusion criterion.

Sites / Locations

  • University Rovira i VirgiliRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Citizen Science Behavioral Intervention

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Risk of sarcopenia (muscle strength)
Change of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
Diagnosis of sarcopenia (muscle strength)
Change of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
Diagnosis of sarcopenia (muscle mass)
Change of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Diagnosis of severe sarcopenia (muscle strength)
Change of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
Diagnosis of severe sarcopenia (muscle mass)
Change of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Diagnosis of severe sarcopenia (muscle function)
Change of muscle function (≤0.8 m / s)

Secondary Outcome Measures

Nutrition
Food frequency questionnaire (not scale)
Physical activity
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).
Sleep behaviour
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.
Risk of malnutrition
Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition
Weight
Weight using a balance
height
Height using a tallimeter

Full Information

First Posted
February 17, 2022
Last Updated
March 15, 2022
Sponsor
University Rovira i Virgili
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1. Study Identification

Unique Protocol Identification Number
NCT05273502
Brief Title
Earlier Elderly People in Rural Areas
Official Title
Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Rural Areas
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
May 15, 2022 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Rovira i Virgili

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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. 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.
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 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. Therefore increase the adherence to the solutions created, and also the long-term sustainability of the solutions. 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, and the sectors involved, to determine their needs, interests, and barriers to pursuing healthy lifestyles. Based on the information obtained in the diagnosis and group interviews, 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 sectors involved in the 4-helix (government, industry, university, and civil society) will be involved. In addition, participants will receive the intervention co-created by themselves, and the effectiveness of the intervention created will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Behavior, Sarcopenia, Nutrition, Sleep, Physical Activity, Lifestyle, Healthy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial (cluster)
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Citizen Science Behavioral Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The controls group (CG) participants will not receive any kind of intervention, and participants will only be assessed at baseline and end-of-study.
Intervention Type
Behavioral
Intervention Name(s)
Citizen Science intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Risk of sarcopenia (muscle strength)
Description
Change of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
Time Frame
Baseline and through study completion, an average of 1 year
Title
Diagnosis of sarcopenia (muscle strength)
Description
Change of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
Time Frame
Baseline and through study completion, an average of 1 year
Title
Diagnosis of sarcopenia (muscle mass)
Description
Change of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Time Frame
Baseline and through study completion, an average of 1 year
Title
Diagnosis of severe sarcopenia (muscle strength)
Description
Change of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
Time Frame
Baseline and through study completion, an average of 1 year
Title
Diagnosis of severe sarcopenia (muscle mass)
Description
Change of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Time Frame
Baseline and through study completion, an average of 1 year
Title
Diagnosis of severe sarcopenia (muscle function)
Description
Change of muscle function (≤0.8 m / s)
Time Frame
Baseline and through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Nutrition
Description
Food frequency questionnaire (not scale)
Time Frame
Baseline and through study completion, an average of 1 year
Title
Physical activity
Description
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).
Time Frame
Baseline and through study completion, an average of 1 year
Title
Sleep behaviour
Description
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.
Time Frame
Baseline and through study completion, an average of 1 year
Title
Risk of malnutrition
Description
Mini Nutritional Assessment 12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition
Time Frame
Baseline and through study completion, an average of 1 year
Title
Weight
Description
Weight using a balance
Time Frame
Baseline and through study completion, an average of 1 year
Title
height
Description
Height using a tallimeter
Time Frame
Baseline and through study completion, an average of 1 year
Other Pre-specified Outcome Measures:
Title
Age
Description
Age in years
Time Frame
Baseline and through study completion, an average of 1 year
Title
Gender
Description
Female or male
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Failure to comply with the inclusion criteria will be considered an exclusion criterion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rosa Solà, Dr
Phone
0034 977759369
Email
rosa.sola@urv.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Tarro, Dr
Phone
0034 977758920
Email
lucia.tarro@urv.cat
Facility Information:
Facility Name
University Rovira i Virgili
City
Reus
State/Province
Tarragona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Solà, Dr
Phone
636 944 723
Ext
0034
Email
rosa.sola@urv.cat

12. IPD Sharing Statement

Plan to Share IPD
No

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Earlier Elderly People in Rural Areas

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