Physical InactivityNCT06260995
The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Study Protocol
An observational study of Physical Inactivity, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Social Prescribing Link Worker Intermediary Intervention and Local Sports Partnership Community Development Officer Intervention
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 1 Sep 2023to 23 Aug 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants are adults aged >18 years old, able to give explicit informed consent, referred to an intermediary and that the intermediary plans to connect to local physical activities.
Who may be able to join
- Aged ≥18 years
- Referred to intermediary service for any reason OR self-referred to intermediary service for any reason
- Meets the eligibility criteria of the intermediary service
- Intermediary facilitates a connection to local physical activity
Who cannot join
- Non-community dwelling e.g., hospital in-patients, living in residential care facilities
- Diagnosis of dementia
- Inappropriate for health or social reasons (such as terminal illness, family or other social crisis)
- Refused to engage with the intermediary service
- Unable to give explicit informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Protocol for a Non-randomized Pilot Feasibility Trial
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 people's 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.
Read the 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.
- Conditions
- Physical Inactivity
- Being tested
- Social Prescribing Link Worker Intermediary Intervention, Local Sports Partnership Community Development Officer Intervention
- Keywords
- Exercise, Physical Activity, Health Promotion, Referral and Consultation, Social Prescribing, Link Workers, Intermediaries
- 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 Prescribing Link Worker Intermediary InterventionOther
Social prescribing link workers [SPLW] receive referrals from healthcare professionals, community services, or through self-referral. Individuals are referred for social isolation or social needs, frequent healthcare attendance, or to address a pre-existing health issue. SPLW carry out an in-depth assessment of the individual's needs, and then work with the individual over weeks and months to connect them to community services and supports, which can include local physical activities. They use several strategies during this follow-up period, such as instrumental support (doing things for the individual), empowerment and motivation techniques and/or attending activities with the individual. After the SPLW establishes a connection to a local physical activity, the individual enrols and participates in the chosen activity. Local physical activities can include walking groups, local gyms and leisure centres, chair-based exercise, outdoor activities, yoga and tai chi.
Local Sports Partnership Community Development Officer InterventionOther
Local sports partnership community development officers [LSPO] mainly receive self-referrals, or can receive referrals, to improve physical activity levels of individuals through participation in physical activity groups delivered by the partnership. LSPO do not carry out an in-depth assessment but may carry out screening before explaining/signposting to local physical activities. They use several strategies to connect the individual to local physical activities, such as attending the first session of the group, providing reassurance and practical support, and keeping the person updated and informed as to upcoming groups. After the LSPO establishes a connection to a local physical activity, the individual enrols and participated in the chosen activity. The LSPO continues to support this engagement during the follow-up period. Local physical activities can include walking groups, local gyms and leisure centres, chair-based exercise, outdoor activities, yoga and tai chi amongst others.
| Study group | Role | What they receive |
|---|---|---|
| Social Prescribing | Participants are those who are referred or self-referred to a social prescribing link worker for any reason and who undergo an intervention delivered by an intermediary i.e., undergo assessment, follow-up, and onward connection to local physical activities. Receives: Other: Social Prescribing Link Worker Intermediary Intervention | |
| Local Sports Partnership | Participants are those who are referred or self-referred to a local sports partnership community development officer for any reason and who undergo an intervention delivered by an intermediary i.e., undergo assessment, follow-up, and onward connection to local physical activities. Receives: Other: Local Sports Partnership Community Development Officer Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Physical Activity Questionnaire - Short Form
The IPAQ-SF assesses physical activity behaviour over the last seven days and includes measures of frequency and duration of vigorous physical activity, moderate physical activity, walking and sedentary behaviour. Using a standardised scoring protocol, total days of activity, total activity (minutes/week), metabolic equivalent minutes per week and physical activity category (low, moderate or high levels of physical activity) can be calculated.
Measured: At baseline (T0) and at the 12-week follow-up assessment (T1)
Self-Efficacy for Exercise Scale
A self-report measure of self-efficacy for physical activity, participants are asked to rate their current confidence in their ability to exercise three times per week for 20 minutes under different scenarios. Responses are rated on a numerical rating scale of 0-10, with 0 indicating 'not confident' and 10 indicating 'very confident'. The overall score is calculated by summing the responses to each scenario, and a higher score indicates higher self-efficacy for exercise.
Measured: At baseline (T0) and at the 12-week follow-up assessment (T1)
Short Warwick Edinburgh Mental Well-being Scale
A scale whose items cover different aspects of eudemonic and hedonic well-being. Each item is answered on a 1 to 5 Likert scale, ranging from "none of the time" to "all the time". The overall score is calculated by summing the scores for each item, and a higher score indicates a higher level of well-being.
Measured: At baseline (T0) and at the 12-week follow-up assessment (T1)
Secondary outcomes (5)
Demographics and Health Status
Participant age, gender, marital status, area in which they live (urban/rural), level of education, ethnicity, employment status, self-reported presence/absence of chronic condition, self-reported rating of health, and types of exercise currently undertaken will be collected at baseline. These data will be used to report demographic information and health-related behaviours of the study sample.
Measured: At baseline assessment (T0). Self-reported rating of health and types of exercise will also be recorded at the 12 week follow-up assessment (T1)
Semi-structured Interviews - Intervention Participants
This interview will explore topics such as: the content and delivery of the intervention by the intermediary, the local physical activities accessed as a result of the intervention and adherence to these, the level of support provided by the intermediary and the impact of this, and acceptability of the study measures and intervention by an intermediary.
Measured: At the 12-week follow-up assessment (T1)
Overall Acceptability of the Intervention
As part of the semi-structured interview, participants will be asked to rate the overall acceptability of the intervention on a numerical rating scale of 1-10, with 1 indicating 'completely unacceptable' and 10 indicating 'completely acceptable'. This will allow the investigators to explore what drives participants' general acceptability judgment.
Measured: At the 12-week follow-up assessment (T1)
Gatekeeper Recruitment Logs
Gatekeepers will be asked to keep a record of how many clients they had contact with during the recruitment period, how many people were approached about the study, and the reasons for refusal to take part in the study. These will be used to measure rates of recruitment and enrollment, and the suitability of the recruitment methods.
Measured: Ongoing throughout the recruitment period
Semi-structured Interviews - Gatekeepers
This interview will explore topics such as: how open individuals were to take part in research and reasons given as to why they did not take part, their experience of discussing the research project with potential participants, and timing of recruitment.
Measured: At the end of the recruitment period, when recruitment logs have been returned
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Sep 2023
- Primary completion6 Jun 2024
- Study completion23 Aug 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 Physical InactivityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan O'Grady, University of Dublin, Trinity College
- Investigators
- Megan O'Grady, Principal investigator, University of Dublin, Trinity College DublinEmer Barrett, PhD, Principal investigator, University of Dublin, Trinity College DublinDeirdre Connolly, PhD, Principal investigator, University of Dublin, Trinity College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260995
- Sponsor's protocol ID
- Ref: 230603
- Status last verified
- May 2026
- First submitted
- 7 Feb 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the research team will have access to data.
Publications
O'Grady M, Connolly D, Barrett E. The role of intermediaries in connecting individuals to local physical activity - protocol for a pilot feasibility trial. Contemp Clin Trials Commun. 2024 Jul 9;41:101332. doi: 10.1016/j.conctc.2024.101332. eCollection 2024 Oct.
PubMed 39129821
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Protocol for a Non-randomized Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT06260995
- Acronym / sponsor ID
- Ref: 230603
- Conditions
- Physical Inactivity
- Keywords
- Exercise, Physical Activity, Health Promotion, Referral and Consultation, Social Prescribing, Link Workers, Intermediaries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 15 Feb 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.
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 people's 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social Prescribing | – | Other: Social Prescribing Link Worker Intermediary InterventionParticipants are those who are referred or self-referred to a social prescribing link worker for any reason and who undergo an intervention delivered by an intermediary i.e., undergo assessment, follow-up, and onward connection to local physical activities. |
| Local Sports Partnership | – | Other: Local Sports Partnership Community Development Officer InterventionParticipants are those who are referred or self-referred to a local sports partnership community development officer for any reason and who undergo an intervention delivered by an intermediary i.e., undergo assessment, follow-up, and onward connection to local physical activities. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants are adults aged >18 years old, able to give explicit informed consent, referred to an intermediary and that the intermediary plans to connect to local physical activities.
Key inclusion criteria (4 listed)
- Aged ≥18 years
- Referred to intermediary service for any reason OR self-referred to intermediary service for any reason
- Meets the eligibility criteria of the intermediary service
- Intermediary facilitates a connection to local physical activity
Key exclusion criteria (5 listed)
- Non-community dwelling e.g., hospital in-patients, living in residential care facilities
- Diagnosis of dementia
- Inappropriate for health or social reasons (such as terminal illness, family or other social crisis)
- Refused to engage with the intermediary service
- Unable to give explicit informed consent
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 Prescribing Link Worker Intermediary InterventionSocial prescribing link workers [SPLW] receive referrals from healthcare professionals, community services, or through self-referral. Individuals are referred for social isolation or social needs, frequent healthcare attendance, or to address a pre-existing health issue. SPLW carry out an in-depth assessment of the individual's needs, and then work with the individual over weeks and months to connect them to community services and supports, which can include local physical activities. They use several strategies during this follow-up period, such as instrumental support (doing things for the individual), empowerment and motivation techniques and/or attending activities with the individual. After the SPLW establishes a connection to a local physical activity, the individual enrols and participates in the chosen activity. Local physical activities can include walking groups, local gyms and leisure centres, chair-based exercise, outdoor activities, yoga and tai chi. | Other | Social Prescribing |
| Local Sports Partnership Community Development Officer InterventionLocal sports partnership community development officers [LSPO] mainly receive self-referrals, or can receive referrals, to improve physical activity levels of individuals through participation in physical activity groups delivered by the partnership. LSPO do not carry out an in-depth assessment but may carry out screening before explaining/signposting to local physical activities. They use several strategies to connect the individual to local physical activities, such as attending the first session of the group, providing reassurance and practical support, and keeping the person updated and informed as to upcoming groups. After the LSPO establishes a connection to a local physical activity, the individual enrols and participated in the chosen activity. The LSPO continues to support this engagement during the follow-up period. Local physical activities can include walking groups, local gyms and leisure centres, chair-based exercise, outdoor activities, yoga and tai chi amongst others. | Other | Local Sports Partnership |
Primary outcome
International Physical Activity Questionnaire - Short Form
Time frame: At baseline (T0) and at the 12-week follow-up assessment (T1)
The IPAQ-SF assesses physical activity behaviour over the last seven days and includes measures of frequency and duration of vigorous physical activity, moderate physical activity, walking and sedentary behaviour. Using a standardised scoring protocol, total days of activity, total activity (minutes/week), metabolic equivalent minutes per week and physical activity category (low, moderate or high levels of physical activity) can be calculated.
Self-Efficacy for Exercise Scale
Time frame: At baseline (T0) and at the 12-week follow-up assessment (T1)
A self-report measure of self-efficacy for physical activity, participants are asked to rate their current confidence in their ability to exercise three times per week for 20 minutes under different scenarios. Responses are rated on a numerical rating scale of 0-10, with 0 indicating 'not confident' and 10 indicating 'very confident'. The overall score is calculated by summing the responses to each scenario, and a higher score indicates higher self-efficacy for exercise.
Short Warwick Edinburgh Mental Well-being Scale
Time frame: At baseline (T0) and at the 12-week follow-up assessment (T1)
A scale whose items cover different aspects of eudemonic and hedonic well-being. Each item is answered on a 1 to 5 Likert scale, ranging from "none of the time" to "all the time". The overall score is calculated by summing the scores for each item, and a higher score indicates a higher level of well-being.
5 secondary outcomes
Demographics and Health Status
Time frame: At baseline assessment (T0). Self-reported rating of health and types of exercise will also be recorded at the 12 week follow-up assessment (T1)
Semi-structured Interviews - Intervention Participants
Time frame: At the 12-week follow-up assessment (T1)
Overall Acceptability of the Intervention
Time frame: At the 12-week follow-up assessment (T1)
Gatekeeper Recruitment Logs
Time frame: Ongoing throughout the recruitment period
Semi-structured Interviews - Gatekeepers
Time frame: At the end of the recruitment period, when recruitment logs have been returned
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 12 May 2026.
- Derived from this study: PubMed 39129821O'Grady M, Connolly D, Barrett E. The role of intermediaries in connecting individuals to local physical activity - protocol for a pilot feasibility trial. Contemp Clin Trials Commun. 2024 Jul 9;41:101332. doi: 10.1016/j.conctc.2024.101332. eCollection 2024 Oct.
- Individual participant dataSharing planned: No. Only the research team will have access to data.
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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.
Megan O'Grady principal investigator
University of Dublin, Trinity College Dublin
Emer Barrett, PhD principal investigator
University of Dublin, Trinity College Dublin
Deirdre Connolly, PhD principal investigator
University of Dublin, Trinity College Dublin
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 Physical Inactivity, run by University of Dublin, Trinity College at 1 site in Ireland.
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 4 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 12 May 2026. 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 Ireland. 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?
International Physical Activity Questionnaire - Short Form (time frame: At baseline (T0) and at the 12-week follow-up assessment (T1)). The study lists 3 primary outcomes in all. 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 NCT06260995, 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 12 May 2026.