NCT06093178

Brief Summary

This research is taking place to find out if a smartphone app plus a health coach can support citizens of Athy, Co. Kildare Ireland to make healthy changes in your lifestyle - small changes for better health. This is the first study of its kind in Ireland; Athy is the first town to take part. Connect5 Athy smartphone app will have a health coach who will advise and support participants make new healthy lifestyle habits linked to sleep, managing stress, increasing physical activity, support healthy eating, cultivate positive local relationships, and help to avoid risky substances like tobacco and alcohol. This is a 6-month observational study that will be conducted between May and October 2024.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 10, 2023

Last Update Submit

October 23, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Reach of the recruitment process into the target population (community of 9000 citizens).

    Reach will be assessed by counting the number of recruited participants as a percentage of the target community, with a population of 9000. This will occur in month 1.

    Month 1

  • Adoption of the digital platform by study participants during the project

    Adoption will be assessed by calculating the uptake (number of participants who log onto the platform via the smartphone app, compared to those who initially consented), and attrition rates (the number of participants who stopped logging onto the platform via the smartphone app) during the 6 month project.

    Month 1 to 6

  • Engagement as behaviour with the digital health-coaching platform at the end of the 6-month project

    Engagement as behaviour will be assessed by calculating the total login attempts (via the project smartphone app) for each participant at the end of the 6 month project

    Month 1 to 6

  • The experience of a representative number of study participants with the coach-led digital platform, with an emphasis on barriers to and facilitators of engagement using semi-structured interviews

    The opinions of a representative number (10%) of study participants will be sought using semi structured interviews (conducted at the end of month 6 with an experienced researcher), using a professional Zoom account. A specific emphasis will be placed on addressing barriers to and facilitators of engagement with the smartphone app and the online coach.

    Month 6

Secondary Outcomes (3)

  • Changes in the perceived stress of participants using the Perceived Stress Scale (PSS).

    Month 1 to 6

  • Changes in wellbeing of participants using the Positive emotion, Engagement, Relationships, Meaning, Accomplishment - Negative emotion, Health, Loneliness (PERMA-NHL) Profiler.

    Month 1 to 6

  • Changes in healthy lifestyle practices, using the American College of Lifestyle Medicine short form (ACLM-SF) assessment.

    Month 1 to 6

Study Arms (1)

Residents of Athy, Co. Kildare

Anyone who lives, works or plays in Athy and the surrounding 5 Km who is over 18 years is invited to take part.

Behavioral: Human coach-led digital health platform

Interventions

This is an existing commercial digital platform developed by our technology partners (Empeal). The platform comes in the form of a smartphone app available via Android and Apple devices. Participants will communicate with their coach through the app via video, audio or text. Surveys are conducted on the app. Support content is also available through this app.

Residents of Athy, Co. Kildare

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any citizen who lives works or plays in Athy or the surrounding hinterland and townlands within a 5 KM radius of the town centre. The investigators expect citizens to be of mixed health with some participants having a diagnosis if a noncommunicable chronic disease or other type of chronic diagnosis e.g., heart disease. The remainder are expected to be of general sound health but would like to improve their health status through changes in lifestyle.

You may qualify if:

  • Any citizen who lives works or plays in Athy or the surrounding hinterland and townlands within a 5 KM radius of the town centre
  • Over 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal College of Surgeons in Ireland, University of Medicine and Health Sciences

Dublin, D02 YN77, Ireland

Location

Central Study Contacts

Padraic J Dunne, PhD

CONTACT

Roisin O'Donovan, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 23, 2023

Study Start

May 1, 2024

Primary Completion

October 31, 2024

Study Completion

November 30, 2024

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

We will publish aggregate summary anonymous data on Zenodo.com.

Locations