Health BehaviorNCT05273502
Earlier Elderly People in Rural Areas
A study testing Citizen Science intervention in people with Health Behavior and Sarcopenia, run by University Rovira i Virgili at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Sarcopenia, Nutrition
- What is being tested?
- Citizen Science intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Failure to comply with the inclusion criteria will be considered an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University Rovira i Virgili
Reus, Tarragona
Rosa Solà, Dr, 636 944 723 ext. 0034, rosa.sola@urv.cat
About this study
Official title: Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Rural 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. 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.
Read the 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.
- Conditions
- Health Behavior, Sarcopenia, Nutrition, Sleep, Physical Activity, Lifestyle, Healthy
- Being tested
- Citizen Science intervention
- Medical subject headings
- Health Behavior, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citizen Science interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of sarcopenia (muscle strength)
Change of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline and through study completion, an average of 1 year
Diagnosis of severe sarcopenia (muscle function)
Change of muscle function (≤0.8 m / s)
Measured: Baseline and through study completion, an average of 1 year
Secondary outcomes (6)
Nutrition
Food frequency questionnaire (not scale)
Measured: Baseline and through study completion, an average of 1 year
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).
Measured: Baseline and through study completion, an average of 1 year
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.
Measured: Baseline and through study completion, an average of 1 year
Risk of malnutrition
Mini Nutritional Assessment
12-14 points: normal nutritional status 8-11 points: risk of malnutrition 0-7 points: malnutrition
Measured: Baseline and through study completion, an average of 1 year
Weight
Weight using a balance
Measured: Baseline and through study completion, an average of 1 year
height
Height using a tallimeter
Measured: Baseline and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Mar 2022
- Primary completion15 May 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (cluster)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273502
- Sponsor's protocol ID
- Earlier-Elderly Rural People
- Status last verified
- Mar 2022
- First submitted
- 17 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization, Creativity, Leadership, and Search for Solutions to Improve the Lifestyles of Earlier Elderly People in Rural Areas
- ClinicalTrials.gov ID
- NCT05273502
- Acronym / sponsor ID
- Earlier-Elderly Rural People
- Conditions
- Health Behavior, Sarcopenia, Nutrition, Sleep, Physical Activity, Lifestyle, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (cluster)
| Arm | Type | Receives |
|---|---|---|
| Citizen Science Behavioral Intervention | Experimental | Behavioral: Citizen Science interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Failure to comply with the inclusion criteria will be considered an exclusion criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citizen Science interventionIntervention 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. | Behavioural | Citizen Science Behavioral Intervention |
Primary outcome
Risk of sarcopenia (muscle strength)
Time frame: Baseline and through study completion, an average of 1 year
Change of muscle strength: <27kg in men and <16kg in women measured by a dynamometer
Diagnosis of sarcopenia (muscle strength)
Time frame: Baseline and through study completion, an average of 1 year
Change of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
Diagnosis of sarcopenia (muscle mass)
Time frame: Baseline and through study completion, an average of 1 year
Change of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Diagnosis of severe sarcopenia (muscle strength)
Time frame: Baseline and through study completion, an average of 1 year
Change of muscle strength (<27kg in men and <16kg in women measured by a dynamometer)
Diagnosis of severe sarcopenia (muscle mass)
Time frame: Baseline and through study completion, an average of 1 year
Change of muscle mass (<20kg in men and <15kg in women measured by bioimpedance)
Diagnosis of severe sarcopenia (muscle function)
Time frame: Baseline and through study completion, an average of 1 year
Change of muscle function (≤0.8 m / s)
6 secondary outcomes
Nutrition
Time frame: Baseline and through study completion, an average of 1 year
Physical activity
Time frame: Baseline and through study completion, an average of 1 year
Sleep behaviour
Time frame: Baseline and through study completion, an average of 1 year
Risk of malnutrition
Time frame: Baseline and through study completion, an average of 1 year
Weight
Time frame: Baseline and through study completion, an average of 1 year
height
Time frame: Baseline and through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Health Behavior
Not yet recruitingObservational study
A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of Central Ohio Health Study to Understand Acculturation as Synergizing Socioenvironmental and Biobehavioral Risk Factors Propagating ...
Cardiometabolic Risk Factors, Mental Health
RecruitingObservational study
Pediatric Research in the Outpatient Setting CoHort
Parental Stress, Communication Disorder, Childhood
Active, not recruiting
Health enSuite Caregivers: an App-based Treatment for Distressed Caregivers of Persons With Moderate Dementia
Caregiver Burnout
Active, not recruiting
AI Mental Health Tool vs. Psychoeducation Control
Depressive Disorder, Depressive Symptoms
Active, not recruitingObservational study
Gulf Long-Term Follow-Up Study
Cardiovascular Disease, Hematologic Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citizen Science intervention in people with Health Behavior and Sarcopenia, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosa Solà, Dr (0034 977759369, rosa.sola@urv.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of sarcopenia (muscle strength) (time frame: Baseline and through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.