NCT06260995

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

February 7, 2024

Last Update Submit

May 7, 2026

Conditions

Keywords

ExercisePhysical ActivityHealth PromotionReferral and ConsultationSocial PrescribingLink WorkersIntermediaries

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    At baseline (T0) and at the 12-week follow-up assessment (T1)

Secondary Outcomes (5)

  • Demographics and Health Status

    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

    At the 12-week follow-up assessment (T1)

  • Overall Acceptability of the Intervention

    At the 12-week follow-up assessment (T1)

  • Gatekeeper Recruitment Logs

    Ongoing throughout the recruitment period

  • Semi-structured Interviews - Gatekeepers

    At the end of the recruitment period, when recruitment logs have been returned

Study Arms (2)

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.

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.

Other: Local Sports Partnership Community Development Officer Intervention

Interventions

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.

Social Prescribing

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.

Local Sports Partnership

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Dublin, Trinity College Dublin

Dublin, D08 W9RT, Ireland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Megan O'Grady

    University of Dublin, Trinity College Dublin

    PRINCIPAL INVESTIGATOR
  • Emer Barrett, PhD

    University of Dublin, Trinity College Dublin

    PRINCIPAL INVESTIGATOR
  • Deirdre Connolly, PhD

    University of Dublin, Trinity College Dublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 15, 2024

Study Start

September 1, 2023

Primary Completion

June 6, 2024

Study Completion

August 23, 2024

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Only the research team will have access to data.

Locations