ActivityNCT06407557
Optimizing Older Adults' Home Space for Physical Activity
A study testing Accelerometer in people with Activity, run by Swansea University at 1 site in United Kingdom.
Trial summary
There will be a multi-channel approach to recruitment. Currently, ongoing projects within diverse communities lead in Swansea, Bridgend, and Neath Port Talbot will be approached, and this research will recruit alongside these projects. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Activity
- What is being tested?
- Accelerometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2024to 22 Apr 2024
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All participants aged ≥ 65 years old and able to do their daily living activities.
- Be able to communicate in English.
- Self-reported daily sitting time of 6 hours/day
Who cannot join
- • are not able to cooperate with the research team for the full duration of the project.
- any exercise contraindications
- cognitive impairment, or other mental health diagnosis and/or psychological impairment.
- living in a supported nursing home or in long-term care.
- participating in daily moderate to vigorous physical activity level (> 150 minutes/week) These criteria were put in place to ensure a group of sedentary older adults who could safely alter their sitting habits in an unsupervised intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Older Adults' Home Space: Feasibility Trial to Reduce Sedentary Behaviour and Increase Physical Activity.
There will be a multi-channel approach to recruitment. Currently, ongoing projects within diverse communities lead in Swansea, Bridgend, and Neath Port Talbot will be approached, and this research will recruit alongside these projects. Regional coordinators and sub-coordinators will be contacted for recruitment, to best ensure participating older adults reflect the typical socio-demographics of Wales. This network will help the researchers to reach older adults who previously took part in different projects. Recruitment letter posters/leaflets will be used as an enrolment technique. Furthermore, the researchers will place advertisements across the University using the intranet and work alongside the City and County of Swansea, Neath Port Talbot, and Bridgend Borough Council to recruit using their sport, play, and community networks. The first stage of recruitment involves approaching diverse community organizations to formally request approval to recruit via their contacts. In-stage gatekeepers will be approached by the researcher to seek permission to contact potential participants via their organization. All interested participants will be asked to contact the researcher directly to further discuss the study and indicate their interest. All participants will provide written informed consent to participate in the study before the baseline assessment is conducted. Moreover, each older adult will receive a sleeping log (to record not wearing time), an accelerometer device, and instructions on how to attach and wear the device for 7 consecutive days. The primary researcher will be contacted if older adults have any queries or issues with the device. The participants will be subsequently randomized to an intervention group or comparison group on the basis of 1:1 allocation. All assessments including questionnaires and a 7-day accelerometer assessment will be repeated post-intervention. An Independent t-test will be run to assess the pre-post difference in the effectiveness of the trial in the intervention and comparison groups. The regression model will be applied to assess the impact of covariates with the dependent variables (MVPA, daily step count, self-efficacy, well-being, and sedentary behaviour). Qualitative data analysis of interview data will use reflexive thematic analysis to illustrate common themes regarding the acceptability of the feasibility trial.
Read the detailed description
There will be a multi-channel approach to recruitment. Currently, ongoing projects within diverse communities lead in Swansea, Bridgend, and Neath Port Talbot will be approached, and this research will recruit alongside these projects. Regional coordinators and sub-coordinators will be contacted for recruitment, to best ensure participating older adults reflect the typical socio-demographics of Wales. This network will help the researchers to reach older adults who previously took part in different projects. Recruitment letter posters/leaflets will be used as an enrolment technique. Furthermore, the researchers will place advertisements across the University using the intranet and work alongside the City and County of Swansea, Neath Port Talbot, and Bridgend Borough Council to recruit using their sport, play, and community networks. Step 1: In step 1 of recruitment, the lead researcher will request approval from the project leads to make a visit to pitch for participants to both explain the study and provide important information to older adults. Interested older adults will be asked to write down their name and preferred contact details in the space provided on the study letters, and to return them to their respective area project lead. Step 2: The researcher will contact interested older adults via email or phone. Older adults who agree to take part will receive participant information sheets, which will be arranged for the researcher to meet them in their home. Step 3: The lead researcher will explain the study process and procedures and answer any questions ensuring the person is fully informed of the nature of the study and how taking part will affect them. Providing the older adult is happy to proceed, they will be given a consent form to sign where the baseline assessment can be undertaken. The first stage of recruitment involves approaching diverse community organizations to formally request approval to recruit via their contacts. Based on the premise that approval is obtained, in-stage gatekeepers will be approached by the researcher to seek permission to contact potential participants via their organization. Gatekeepers will, in no instance, be asked to discuss the study with potential participants. Rather, they will be approached to identify individuals to gain approval to contact individuals to describe the study and share pertinent information. All interested participants will be asked to contact the researcher directly to further discuss the study and indicate their interest. The researcher will organize a time for formal enrolment and induction into the study with the interested older adults. All participants will provide written informed consent to participate in the study before the baseline assessment is conducted. Moreover, each older adult will receive a sleeping log (to record not wearing time), an accelerometer device, and instructions on how to attach and wear the device for 7 consecutive days. The primary researcher will be contacted if older adults have any queries or issues with the device. The participants will be subsequently randomized to an intervention group or comparison group on the basis of 1:1 allocation. All assessments including questionnaires and a 7-day accelerometer assessment will be repeated post-intervention. The normality of the outcome variable will be assessed through a histogram. An Independent t-test will be run to assess the pre-post difference in the effectiveness of the trial in the intervention and comparison groups. The regression model will be applied to assess the impact of covariates with the dependent variables (MVPA, daily step count, self-efficacy, well-being, and sedentary behaviour). Qualitative data analysis of interview data will use reflexive thematic analysis to illustrate common themes regarding the acceptability of the feasibility trial. Using this approach, notes and initial impressions will be taken by the researcher during the interviews. These themes will be tracked and continually revised throughout transcription and later themes are developed based on underlying meaning.
- Conditions
- Activity
- Being tested
- Accelerometer
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerBehavioural
Use of prompts to enable activity in older adults.
| Study group | Role | What they receive |
|---|---|---|
| Accelerometer | Active comparator | Not described Receives: Behavioral: Accelerometer |
| No arm accelerometer | Active comparator | Not described Receives: Behavioral: Accelerometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessment
Retention = Older adults completed post intervention assessment (semi-structured interviews)/ older adults enrolled * 100
Measured: 2 months
Secondary outcomes (7)
Activity
Activity will be measured with a wrist-worn accelerometer (Actigraph wGT9X Link+, Pensacola, FL).
Measured: 2 months
Self-efficacy
Self-efficacy for activity will be measured using the Self-Efficacy for Exercise Scale. The Self-Efficacy for Exercise Scale is a self-report measure with 5 items assessing one's degree of confidence in the ability to perform activity. The score is the sum of the item responses; higher scores indicate greater self-efficacy.
Measured: 2 months
Sitting Behaviours
Self-Report Habit Index will be used to measure habits associated to SB (Sedentary Behaviour) and PA (Physical Activity), previously validated in studies.
Measured: 2 months
Well-being
The Warwick-Edinburgh Mental Wellbeing Scale, a 14-item self-report measure, will be used to assess well-being. Respondents rate their experience regarding each statement over the last 2 weeks. Each item is scored using a 5-point Likert scale ranging from 1 (none of the time) to 5 (all of the time), with the total score ranging from 14 (low well-being) to 70.
Measured: 2 months
Acceptability
Semi-structured interviews
Measured: 3 months
Uptake
The intervention uptake will be assessed as:
Uptake = Older adults enrolled/older adults invited to take part in the study * 100
Measured: 4 months
Data Completeness
Data completeness: The data completeness will be assessed as:
Data completeness = Older adults return to complete accelerometer derived and self-report data/older adults enrolled * 100
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jan 2024
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
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 ActivityStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407557
- Sponsor's protocol ID
- 2 2023 6667 6123
- Status last verified
- May 2024
- First submitted
- 8 Feb 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meghani NAA, Hudson J, Stratton G, Mullins J, Sahoo D. A multi-method feasibility trial of a multi-component behaviour change intervention to reduce sedentary behaviour and increase physical activity among ethnically diverse older adults. BMJ Open. 2024 Nov 7;14(11):e084645. doi: 10.1136/bmjopen-2024-084645.
PubMed 39510783
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Older Adults' Home Space: Feasibility Trial to Reduce Sedentary Behaviour and Increase Physical Activity.
- ClinicalTrials.gov ID
- NCT06407557
- Acronym / sponsor ID
- 2 2023 6667 6123
- Conditions
- Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 9 May 2024 (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.
There will be a multi-channel approach to recruitment. Currently, ongoing projects within diverse communities lead in Swansea, Bridgend, and Neath Port Talbot will be approached, and this research will recruit alongside these projects. Regional coordinators and sub-coordinators will be contacted for recruitment, to best ensure participating older adults reflect the typical socio-demographics of Wales. This network will help the researchers to reach older adults who previously took part in different projects. Recruitment letter posters/leaflets will be used as an enrolment technique. Furthermore, the researchers will place advertisements across the University using the intranet and work alongside the City and County of Swansea, Neath Port Talbot, and Bridgend Borough Council to recruit using their sport, play, and community networks. The first stage of recruitment involves approaching diverse community organizations to formally request approval to recruit via their contacts. In-stage gatekeepers will be approached by the researcher to seek permission to contact potential participants via their organization. All interested participants will be asked to contact the researcher directly to further discuss the study and indicate their interest. All participants will provide written informed consent to participate in the study before the baseline assessment is conducted. Moreover, each older adult will receive a sleeping log (to record not wearing time), an accelerometer device, and instructions on how to attach and wear the device for 7 consecutive days. The primary researcher will be contacted if older adults have any queries or issues with the device. The participants will be subsequently randomized to an intervention group or comparison group on the basis of 1:1 allocation. All assessments including questionnaires and a 7-day accelerometer assessment will be repeated post-intervention. An Independent t-test will be run to assess the pre-post difference in the effectiveness of the trial in the intervention and comparison groups. The regression model will be applied to assess the impact of covariates with the dependent variables (MVPA, daily step count, self-efficacy, well-being, and sedentary behaviour). Qualitative data analysis of interview data will use reflexive thematic analysis to illustrate common themes regarding the acceptability of the feasibility trial.
Detailed description
There will be a multi-channel approach to recruitment. Currently, ongoing projects within diverse communities lead in Swansea, Bridgend, and Neath Port Talbot will be approached, and this research will recruit alongside these projects. Regional coordinators and sub-coordinators will be contacted for recruitment, to best ensure participating older adults reflect the typical socio-demographics of Wales. This network will help the researchers to reach older adults who previously took part in different projects. Recruitment letter posters/leaflets will be used as an enrolment technique. Furthermore, the researchers will place advertisements across the University using the intranet and work alongside the City and County of Swansea, Neath Port Talbot, and Bridgend Borough Council to recruit using their sport, play, and community networks. Step 1: In step 1 of recruitment, the lead researcher will request approval from the project leads to make a visit to pitch for participants to both explain the study and provide important information to older adults. Interested older adults will be asked to write down their name and preferred contact details in the space provided on the study letters, and to return them to their respective area project lead. Step 2: The researcher will contact interested older adults via email or phone. Older adults who agree to take part will receive participant information sheets, which will be arranged for the researcher to meet them in their home. Step 3: The lead researcher will explain the study process and procedures and answer any questions ensuring the person is fully informed of the nature of the study and how taking part will affect them. Providing the older adult is happy to proceed, they will be given a consent form to sign where the baseline assessment can be undertaken. The first stage of recruitment involves approaching diverse community organizations to formally request approval to recruit via their contacts. Based on the premise that approval is obtained, in-stage gatekeepers will be approached by the researcher to seek permission to contact potential participants via their organization. Gatekeepers will, in no instance, be asked to discuss the study with potential participants. Rather, they will be approached to identify individuals to gain approval to contact individuals to describe the study and share pertinent information. All interested participants will be asked to contact the researcher directly to further discuss the study and indicate their interest. The researcher will organize a time for formal enrolment and induction into the study with the interested older adults. All participants will provide written informed consent to participate in the study before the baseline assessment is conducted. Moreover, each older adult will receive a sleeping log (to record not wearing time), an accelerometer device, and instructions on how to attach and wear the device for 7 consecutive days. The primary researcher will be contacted if older adults have any queries or issues with the device. The participants will be subsequently randomized to an intervention group or comparison group on the basis of 1:1 allocation. All assessments including questionnaires and a 7-day accelerometer assessment will be repeated post-intervention. The normality of the outcome variable will be assessed through a histogram. An Independent t-test will be run to assess the pre-post difference in the effectiveness of the trial in the intervention and comparison groups. The regression model will be applied to assess the impact of covariates with the dependent variables (MVPA, daily step count, self-efficacy, well-being, and sedentary behaviour). Qualitative data analysis of interview data will use reflexive thematic analysis to illustrate common themes regarding the acceptability of the feasibility trial. Using this approach, notes and initial impressions will be taken by the researcher during the interviews. These themes will be tracked and continually revised throughout transcription and later themes are developed based on underlying meaning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerometer | Active comparator | Behavioral: Accelerometer |
| No arm accelerometer | Active comparator | Behavioral: Accelerometer |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- All participants aged ≥ 65 years old and able to do their daily living activities.
Key exclusion criteria (5 listed)
- • are not able to cooperate with the research team for the full duration of the project.
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 |
|---|---|---|
| AccelerometerUse of prompts to enable activity in older adults. | Behavioural | Accelerometer, No arm accelerometer |
Primary outcome
Feasibility assessment
Time frame: 2 months
Retention = Older adults completed post intervention assessment (semi-structured interviews)/ older adults enrolled * 100
7 secondary outcomes
Activity
Time frame: 2 months
Self-efficacy
Time frame: 2 months
Sitting Behaviours
Time frame: 2 months
Well-being
Time frame: 2 months
Acceptability
Time frame: 3 months
Uptake
Time frame: 4 months
Data Completeness
Time frame: 3 months
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 9 May 2024.
- Derived from this study: PubMed 39510783Meghani NAA, Hudson J, Stratton G, Mullins J, Sahoo D. A multi-method feasibility trial of a multi-component behaviour change intervention to reduce sedentary behaviour and increase physical activity among ethnically diverse older adults. BMJ Open. 2024 Nov 7;14(11):e084645. doi: 10.1136/bmjopen-2024-084645.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer in people with Activity, run by Swansea University at 1 site in United Kingdom.
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 5 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 9 May 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 United Kingdom. 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?
Feasibility assessment (time frame: 2 months). 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 NCT06407557, 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 9 May 2024.