Clinical trial NCT06260995: The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Study Protocol
Official title: The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Protocol for a Non-randomized Pilot Feasibility Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Physical Inactivity
Keywords: Exercise
Physical Activity
Health Promotion
Referral and Consultation
Social Prescribing
Link Workers
Intermediaries
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

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.

Eligibility criteria: Inclusion criteria

* 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

Exclusion criteria

* 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

Primary outcomes:
measure: International Physical Activity Questionnaire - Short Form
timeFrame: At baseline (T0) and at the 12-week follow-up assessment (T1)
measure: Self-Efficacy for Exercise Scale
timeFrame: At baseline (T0) and at the 12-week follow-up assessment (T1)
measure: Short Warwick Edinburgh Mental Well-being Scale
timeFrame: At baseline (T0) and at the 12-week follow-up assessment (T1)
Secondary outcomes:
measure: Demographics and Health Status
timeFrame: 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)
measure: Semi-structured Interviews - Intervention Participants
timeFrame: At the 12-week follow-up assessment (T1)
measure: Overall Acceptability of the Intervention
timeFrame: At the 12-week follow-up assessment (T1)
measure: Gatekeeper Recruitment Logs
timeFrame: Ongoing throughout the recruitment period
measure: Semi-structured Interviews - Gatekeepers
timeFrame: At the end of the recruitment period, when recruitment logs have been returned
Other outcomes:
Locations:
city: Dublin 8
country: Ireland
facility: University of Dublin, Trinity College Dublin
Study officials:
affiliation: University of Dublin, Trinity College Dublin
name: Megan O'Grady
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College Dublin
name: Emer Barrett, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dublin, Trinity College Dublin
name: Deirdre Connolly, PhD
role: PRINCIPAL_INVESTIGATOR
References: