Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06407557
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2024-02-08
Brief Title:
Optimizing Older Adults Home Space for Physical Activity
Sponsor:
Swansea University
Organization:
Swansea University
Study Overview
Official Title:
Optimizing Older Adults Home Space Feasibility Trial to Reduce Sedentary Behaviour and Increase Physical Activity
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 postersleaflets 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 11 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 postersleaflets 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None