Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06260995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2024-02-07
Brief Title:
The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Study Protocol
Sponsor:
University of Dublin Trinity College
Organization:
University of Dublin Trinity College
Study Overview
Official Title:
The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Protocol for a Non-randomized Pilot Feasibility Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
Intermediaries help people to connect to community-based services and supports including physical activity and exercise groups physical activities They do this by acting as a link person After receiving a referral or self-referral they conduct an assessment connect people to services in the community and follow-up with people over time
This project will investigate if connecting to physical activities through an intermediary can improve health and wellbeing It will also investigate peoples experiences of working with an intermediary This project is a pilot feasibility study which means the investigators are evaluating the measures used and the way the trial is designed to see if they are suitable for a larger study in the future
This project will investigate if connecting to physical activities through an intermediary can improve health and wellbeing It will also investigate peoples experiences of working with an intermediary This project is a pilot feasibility study which means the investigators are evaluating the measures used and the way the trial is designed to see if they are suitable for a larger study in the future
Detailed Description:
BACKGROUND
Physical inactivity is a major issue affecting health and was declared a global pandemic by the World Health Organization Effective methods of physical activity promotion are needed An intermediary is an emerging method to address the problem of physical inactivity Intermediaries are health-related workers who support individuals to improve their health and wellbeing by facilitating connections to local physical activities Preliminary evidence for this intervention is positive for improving physical activity levels and wellbeing but is based on trials using less robust designs When evaluating complex interventions feasibility testing is recommended in order to make decisions about progression to the evaluation phase
METHODS
This will be a non-randomized mixed methods pilot feasibility study This overall aim of this study is to investigate the feasibility of an intervention delivered by an intermediary to improve physical activity and health-related outcomes of community-dwelling adults Participants will be recruited through two types of intermediary services in Ireland social prescribing and local sports partnerships A total of 30 participants will be recruited 15 per service This study comprises two strands Strand 1 is a non-randomized prospective cohort study A baseline assessment will be taken upon enrolment on to the study Baseline demographic information will be taken and three questionnaires will be completed the International Physical Activity Questionnaire - Short Form Self-Efficacy for Exercise Scale and Short Warwick Edinburgh Mental Well-being Scale The questionnaires will be repeated after 12 weeks Strand 2 is a qualitative phase consisting of semi-structured exit interviews with intervention participants conducted at the 12-week follow-up assessment These will be carried out to explore intervention content and delivery as well as acceptability of the intervention and evaluation design In addition study gatekeepers will be asked to keep a record of how many clients they had contact with how many people were approached about the study and the reasons for refusal to take part in the study Semi-structured interviews will also be conducted with gatekeepers at the end of the recruitment period to explore the acceptability of the recruitment methods
DISCUSSION
This study will investigate the feasibility of the intervention delivered by an intermediary and any indications of change in physical activity and health-related outcomes It will also investigate the feasibility and acceptability of the evaluation design specifically recruitment methods and choice of outcome measures
Physical inactivity is a major issue affecting health and was declared a global pandemic by the World Health Organization Effective methods of physical activity promotion are needed An intermediary is an emerging method to address the problem of physical inactivity Intermediaries are health-related workers who support individuals to improve their health and wellbeing by facilitating connections to local physical activities Preliminary evidence for this intervention is positive for improving physical activity levels and wellbeing but is based on trials using less robust designs When evaluating complex interventions feasibility testing is recommended in order to make decisions about progression to the evaluation phase
METHODS
This will be a non-randomized mixed methods pilot feasibility study This overall aim of this study is to investigate the feasibility of an intervention delivered by an intermediary to improve physical activity and health-related outcomes of community-dwelling adults Participants will be recruited through two types of intermediary services in Ireland social prescribing and local sports partnerships A total of 30 participants will be recruited 15 per service This study comprises two strands Strand 1 is a non-randomized prospective cohort study A baseline assessment will be taken upon enrolment on to the study Baseline demographic information will be taken and three questionnaires will be completed the International Physical Activity Questionnaire - Short Form Self-Efficacy for Exercise Scale and Short Warwick Edinburgh Mental Well-being Scale The questionnaires will be repeated after 12 weeks Strand 2 is a qualitative phase consisting of semi-structured exit interviews with intervention participants conducted at the 12-week follow-up assessment These will be carried out to explore intervention content and delivery as well as acceptability of the intervention and evaluation design In addition study gatekeepers will be asked to keep a record of how many clients they had contact with how many people were approached about the study and the reasons for refusal to take part in the study Semi-structured interviews will also be conducted with gatekeepers at the end of the recruitment period to explore the acceptability of the recruitment methods
DISCUSSION
This study will investigate the feasibility of the intervention delivered by an intermediary and any indications of change in physical activity and health-related outcomes It will also investigate the feasibility and acceptability of the evaluation design specifically recruitment methods and choice of outcome measures
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