Sedentary BehaviorNCT04136938
Social Marketing in Prevention Actions
An observational study of Sedentary Behavior and Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation and attendance resulting in Physical Activity (PA) approaches designed to prevent… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Aging
- What is being tested?
- Social marketing campaign
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2020to 1 Jul 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People aged 60 and over.
Who may be able to join
- People living in the one of the territories of the study
- People without medical contraindications to participate in moderate physical activity
- People who has received information about the study and its rights to its data
Who cannot join
- People unable to attend workshops
- People already registered for adapted physical activity
- People who refused to participate to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Social Marketing in Collective Prevention Actions : Case of Fall Prevention Workshop Among Elderly Living in Three French Departments.
Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation and attendance resulting in Physical Activity (PA) approaches designed to prevent falls actually only benefiting a limited number of elderly subjects. Social marketing has already shown its utility in the construction of prevention programs.
Read the detailed description
This study uses the social marketing approach to improve a fall prevention program. The intervention territory will receive social marketing campaign while the territory controls will not have a campaign.
The main goal is to improve attendance at our fall prevention program.
- Conditions
- Sedentary Behavior, Aging
- Being tested
- Social marketing campaign
- Keywords
- Fall, Seniors, Physical activity, Prevention
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social marketing campaignOther
A social marketing campaign of prevention workshop sessions will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (social marketing campaign) | People aged 60 and over will be included. They will receive a social marketing campaign. Receives: Other: Social marketing campaign | |
| Control group | People aged 60 and over will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of attendance rate of participants at social marketing campaign (%)
Comparison rate of attendance rate of participants at prevention workshop sessions (%) between interventional and control group.
Measured: Years: 1
Secondary outcomes (3)
Rate of attendance rate of participants at fall prevention workshop sessions (%)
Comparison rate of attendance rate of participants at prevention workshop sessions (%) between interventional and control group.
Measured: Years: 1
Life quality of participants measured by SF-36 questionnaire score
The SF-36 is a self-questionnaire to assess the quality of life and contains 36 items with minimum score 0 (bad quality life) and maximum score at 100 (good quality life).
Measured: Years: 0, 1
Physical activity level of participants measured by IPAQ questionnaire
The International Physical Activity Questionnaire (IPAQ): short version for elderly people is a self-questionnaire to assess the Physical Activity and contains 7 items. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate-intensity and vigorous-intensity activities.
Measured: Years: 0, 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start9 Mar 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Crédit Agricole Loire / Haute-Loire, Jean Monnet University
- Responsible party
- Sponsor
- Investigators
- Luc GOETHALS, PhD student, Principal investigator, Jean Monnet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136938
- Sponsor's protocol ID
- IRBN622019/CHUSTE
- Status last verified
- Jul 2024
- First submitted
- 18 Oct 2019
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goethals L, Barth N, Hupin D, Chapoton B, Guyot J, Celarier T, Roche F, Gallopel-Morvan K, Bongue B. Social Marketing Intervention to Engage Older Adults in Balance Workshops for Fall Prevention: A Multicenter Quasi-Experimental Protocol Study. Front Public Health. 2021 Jul 14;9:614119. doi: 10.3389/fpubh.2021.614119. eCollection 2021.
PubMed 34336750
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Social Marketing in Collective Prevention Actions : Case of Fall Prevention Workshop Among Elderly Living in Three French Departments.
- ClinicalTrials.gov ID
- NCT04136938
- Acronym / sponsor ID
- IRBN622019/CHUSTE
- Conditions
- Sedentary Behavior, Aging
- Keywords
- Fall, Seniors, Physical activity, Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Crédit Agricole Loire / Haute-Loire, Jean Monnet University
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 23 Oct 2019 (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.
Physical Activity (PA) is recognized as the most effective method to prevent falls in the elderly. Yet despite there being a consensus now that Physical Activity (PA) is effective in practice, there remain many obstacles to participation and attendance resulting in Physical Activity (PA) approaches designed to prevent falls actually only benefiting a limited number of elderly subjects. Social marketing has already shown its utility in the construction of prevention programs.
Detailed description
This study uses the social marketing approach to improve a fall prevention program. The intervention territory will receive social marketing campaign while the territory controls will not have a campaign.
The main goal is to improve attendance at our fall prevention program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (social marketing campaign) | – | Other: Social marketing campaignPeople aged 60 and over will be included. They will receive a social marketing campaign. |
| Control group | – | –People aged 60 and over will be included. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People aged 60 and over.
Key inclusion criteria (3 listed)
- People living in the one of the territories of the study
- People without medical contraindications to participate in moderate physical activity
- People who has received information about the study and its rights to its data
Key exclusion criteria (3 listed)
- People unable to attend workshops
- People already registered for adapted physical activity
- People who refused to participate to the study.
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 |
|---|---|---|
| Social marketing campaignA social marketing campaign of prevention workshop sessions will be performed. | Other | Intervention group (social marketing campaign) |
Primary outcome
Rate of attendance rate of participants at social marketing campaign (%)
Time frame: Years: 1
Comparison rate of attendance rate of participants at prevention workshop sessions (%) between interventional and control group.
3 secondary outcomes
Rate of attendance rate of participants at fall prevention workshop sessions (%)
Time frame: Years: 1
Life quality of participants measured by SF-36 questionnaire score
Time frame: Years: 0, 1
Physical activity level of participants measured by IPAQ questionnaire
Time frame: Years: 0, 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 34336750Goethals L, Barth N, Hupin D, Chapoton B, Guyot J, Celarier T, Roche F, Gallopel-Morvan K, Bongue B. Social Marketing Intervention to Engage Older Adults in Balance Workshops for Fall Prevention: A Multicenter Quasi-Experimental Protocol Study. Front Public Health. 2021 Jul 14;9:614119. doi: 10.3389/fpubh.2021.614119. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Luc GOETHALS, PhD student principal investigator
Jean Monnet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedentary Behavior and Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jul 2024. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of attendance rate of participants at social marketing campaign (%) (time frame: Years: 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04136938, which also lists 1 linked publication.
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 10 Jul 2024.