Healthy LifestyleCONNECT-5NCT05109026
Connect-5 Needs Assessment Survey to Identify Healthy Lifestyle Requirements of a Rural Irish Community
An observational study of Healthy Lifestyle, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial summary
This is an anonymous needs assessment survey of the population of an Irish urban town. We plan to collect anonymous survey data in order to better understand residents needs and to determine the desired functionality of a new coach-led wellness app operated by our partners. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- How many people
- 228 participants
- Where
- 1 siteIreland
- Study dates
- 5 Sep 2022to 30 Jan 2023
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: We aim to collect survey data from at least 1,820 participants (20% response rate). We will conduct interviews with up to 5 members of each target cohort from the community ( older people, recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, and remote workers).
Who may be able to join
- Participants will be members of the urban town being studied.
Who cannot join
- Non a member of the urban town being studied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Connect-5 Needs Assessment to Identify Requirements of a Rural Irish Community Related to a an Online Digital Platform Solution, Designed to Change Behaviour, Related to Lifestyle Medicine and Mental Health.
This is an anonymous needs assessment survey of the population of an Irish urban town. We plan to collect anonymous survey data in order to better understand residents needs and to determine the desired functionality of a new coach-led wellness app operated by our partners. This platform is currently trialled for health care professionals working in the RCSI Hospital Group. The survey will collect information on participants demographics, their lifestyle (including sleep, exercise, food, relationships, meaning and purpose, substance use and stress management). We will also ask participants about their use of wellness apps to support healthy choices related to their lifestyle. We also plan to conduct a qualitative assessment to further explore needs related to lifestyle health in specific cohorts, namely, older people (65 years and older), recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, secondary school students and remote workers.
Read the detailed description
There has been an increase in lifestyle related diseases worldwide. Living a healthy lifestyle is important to prevent lifestyle-related diseases such as heart disease, obesity, diabetes, mental health issues, certain cancers, autoimmunity and gastro-intestinal disease. The economic impact of these lifestyle-related diseases in Europe alone is set to exceed €200 billion by 2030. Worldwide, one in five people are at an increased risk of developing severe COVID-19, mostly as a result of underlying lifestyle-related diseases. Additionally, global efforts to manage COVID-19 infection have disrupted regular care required by those with these issues. Dealing with this requires that people better manage their own health and address lifestyle related factors that increase the risk associated with such diseases, including inactivity, substance abuse and unhealthy diet. These risk factors are modifiable and can be reduced by health interventions and tools to support a healthy lifestyle.
The COVID-19 pandemic caused prolonged feelings of fear, uncertainty and isolation among the general population. This is likely to impact vulnerable members of society, such as young people, elderly people and those in ethnic minority communities in greater proportions. Children and adolescents are experiencing increased adverse mental health effects such as social isolation, loneliness, depression and anxiety, during the Covid-19 pandemic. Irish adults aged 70 and over have reported worse mental health and increased feelings of loneliness due to cocooning throughout the pandemic. This social isolation and loneliness puts them at increased risk of cognitive and cardiovascular decline. It is important that we prioritise the development of strategies to maintain social engagement, manage loneliness and encourage continued physical activity among older people.
Work habits are currently changing at a rapid pace. Significant sections of our workforces are now working from home and at least 50% are expected to remain at home, even after the current pandemic has resolved. Reports indicate that a significant proportion of this workforce is experiencing issues with disconnection and mental health. As a result, understanding the impact of remote and flexible working arrangements on employee health and mental wellbeing has been included as a research priority within psychological science. While there is evidence that remote working has positive effects on well-being, these effects are not consistent. Remote working may also lead to greater levels of professional isolation, reduced work-life balance, increase work-related fatigue and have negative impacts on well-being. This study is being conducted to better understand citizen's needs in relation to living a healthier lifestyle.
- Conditions
- Healthy Lifestyle
- Keywords
- Survey, Interviews, Needs Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older people | Members of the population aged 65 years and older. | |
| Recent migrants | Members of the population who are recent migrants to the community. | |
| Members of the travelling community | Members of the population who are members of the travelling community. | |
| Perinatal women. | Members of the population who are pregnant or within a year of giving birth. | |
| Lone-parents | Members of the population who are raising children alone. | |
| Individuals with physical disabilities | Members of the population who have a physical disability. | |
| Secondary school students | Members of the population attending secondary school. | |
| Remote workers | Members of the population currently working from home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needs assessment survey
An anonymous needs assessment survey (online and hard copies) will be conducted.
Measured: January 2022-February 2022
Needs assessment interivews
Anonymous qualitative interviews will be conducted in conjunction with community liaison officers, over the telephone with up to 5 members of the following target groups - older people (65 years and older), recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, and remote workers.
Measured: January 2022-March 2022
Analysis
Analysis of summary anonymous aggregate data will be used to inform future stages of this research.
Measured: March 2022- April 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start5 Sep 2022
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Healthy LifestyleStudies 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
- Cross-sectional
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Private Philanthropic Funder
- Responsible party
- Principal investigator, Padraic Dunne, Royal College of Surgeons, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109026
- Sponsor's protocol ID
- Connect-5 Needs Assessment
- Acronym
- CONNECT-5
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2021
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only summary aggregate data will be shared.
Publications
Ng R, Sutradhar R, Yao Z, Wodchis WP, Rosella LC. Smoking, drinking, diet and physical activity-modifiable lifestyle risk factors and their associations with age to first chronic disease. Int J Epidemiol. 2020 Feb 1;49(1):113-130. doi: 10.1093/ije/dyz078.
PubMed 31329872Hyland P, Shevlin M, McBride O, Murphy J, Karatzias T, Bentall RP, Martinez A, Vallieres F. Anxiety and depression in the Republic of Ireland during the COVID-19 pandemic. Acta Psychiatr Scand. 2020 Sep;142(3):249-256. doi: 10.1111/acps.13219. Epub 2020 Aug 9.
PubMed 32716520Nearchou F, Flinn C, Niland R, Subramaniam SS, Hennessy E. Exploring the Impact of COVID-19 on Mental Health Outcomes in Children and Adolescents: A Systematic Review. Int J Environ Res Public Health. 2020 Nov 16;17(22):8479. doi: 10.3390/ijerph17228479.
PubMed 33207689Loades ME, Chatburn E, Higson-Sweeney N, Reynolds S, Shafran R, Brigden A, Linney C, McManus MN, Borwick C, Crawley E. Rapid Systematic Review: The Impact of Social Isolation and Loneliness on the Mental Health of Children and Adolescents in the Context of COVID-19. J Am Acad Child Adolesc Psychiatry. 2020 Nov;59(11):1218-1239.e3. doi: 10.1016/j.jaac.2020.05.009. Epub 2020 Jun 3.
PubMed 32504808Bailey T, Hastings RP, Totsika V. COVID-19 impact on psychological outcomes of parents, siblings and children with intellectual disability: longitudinal before and during lockdown design. J Intellect Disabil Res. 2021 May;65(5):397-404. doi: 10.1111/jir.12818. Epub 2021 Feb 25.
PubMed 33634520Ward MP. SARS-CoV-2, where to now? Transbound Emerg Dis. 2020 Jul;67(4):1411-1413. doi: 10.1111/tbed.13654. Epub 2020 Jun 19. No abstract available.
PubMed 32562349Fried L, Prohaska T, Burholt V, Burns A, Golden J, Hawkley L, Lawlor B, Leavey G, Lubben J, O'Sullivan R, Perissinotto C, van Tilburg T, Tully M, Victor C. A unified approach to loneliness. Lancet. 2020 Jan 11;395(10218):114. doi: 10.1016/S0140-6736(19)32533-4. No abstract available.
PubMed 31929010Valtorta NK, Kanaan M, Gilbody S, Ronzi S, Hanratty B. Loneliness and social isolation as risk factors for coronary heart disease and stroke: systematic review and meta-analysis of longitudinal observational studies. Heart. 2016 Jul 1;102(13):1009-16. doi: 10.1136/heartjnl-2015-308790. Epub 2016 Apr 18.
PubMed 27091846O'Connor DB, Aggleton JP, Chakrabarti B, Cooper CL, Creswell C, Dunsmuir S, Fiske ST, Gathercole S, Gough B, Ireland JL, Jones MV, Jowett A, Kagan C, Karanika-Murray M, Kaye LK, Kumari V, Lewandowsky S, Lightman S, Malpass D, Meins E, Morgan BP, Morrison Coulthard LJ, Reicher SD, Schacter DL, Sherman SM, Simms V, Williams A, Wykes T, Armitage CJ. Research priorities for the COVID-19 pandemic and beyond: A call to action for psychological science. Br J Psychol. 2020 Nov;111(4):603-629. doi: 10.1111/bjop.12468. Epub 2020 Jul 19.
PubMed 32683689
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect-5 Needs Assessment to Identify Requirements of a Rural Irish Community Related to a an Online Digital Platform Solution, Designed to Change Behaviour, Related to Lifestyle Medicine and Mental Health.
- ClinicalTrials.gov ID
- NCT05109026
- Acronym / sponsor ID
- CONNECT-5 / Connect-5 Needs Assessment
- Conditions
- Healthy Lifestyle
- Keywords
- Survey, Interviews, Needs Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Private Philanthropic Funder
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 5 Nov 2021 (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.
This is an anonymous needs assessment survey of the population of an Irish urban town. We plan to collect anonymous survey data in order to better understand residents needs and to determine the desired functionality of a new coach-led wellness app operated by our partners. This platform is currently trialled for health care professionals working in the RCSI Hospital Group. The survey will collect information on participants demographics, their lifestyle (including sleep, exercise, food, relationships, meaning and purpose, substance use and stress management). We will also ask participants about their use of wellness apps to support healthy choices related to their lifestyle. We also plan to conduct a qualitative assessment to further explore needs related to lifestyle health in specific cohorts, namely, older people (65 years and older), recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, secondary school students and remote workers.
Detailed description
There has been an increase in lifestyle related diseases worldwide. Living a healthy lifestyle is important to prevent lifestyle-related diseases such as heart disease, obesity, diabetes, mental health issues, certain cancers, autoimmunity and gastro-intestinal disease. The economic impact of these lifestyle-related diseases in Europe alone is set to exceed €200 billion by 2030. Worldwide, one in five people are at an increased risk of developing severe COVID-19, mostly as a result of underlying lifestyle-related diseases. Additionally, global efforts to manage COVID-19 infection have disrupted regular care required by those with these issues. Dealing with this requires that people better manage their own health and address lifestyle related factors that increase the risk associated with such diseases, including inactivity, substance abuse and unhealthy diet. These risk factors are modifiable and can be reduced by health interventions and tools to support a healthy lifestyle.
The COVID-19 pandemic caused prolonged feelings of fear, uncertainty and isolation among the general population. This is likely to impact vulnerable members of society, such as young people, elderly people and those in ethnic minority communities in greater proportions. Children and adolescents are experiencing increased adverse mental health effects such as social isolation, loneliness, depression and anxiety, during the Covid-19 pandemic. Irish adults aged 70 and over have reported worse mental health and increased feelings of loneliness due to cocooning throughout the pandemic. This social isolation and loneliness puts them at increased risk of cognitive and cardiovascular decline. It is important that we prioritise the development of strategies to maintain social engagement, manage loneliness and encourage continued physical activity among older people.
Work habits are currently changing at a rapid pace. Significant sections of our workforces are now working from home and at least 50% are expected to remain at home, even after the current pandemic has resolved. Reports indicate that a significant proportion of this workforce is experiencing issues with disconnection and mental health. As a result, understanding the impact of remote and flexible working arrangements on employee health and mental wellbeing has been included as a research priority within psychological science. While there is evidence that remote working has positive effects on well-being, these effects are not consistent. Remote working may also lead to greater levels of professional isolation, reduced work-life balance, increase work-related fatigue and have negative impacts on well-being. This study is being conducted to better understand citizen's needs in relation to living a healthier lifestyle.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Older people | – | –Members of the population aged 65 years and older. |
| Recent migrants | – | –Members of the population who are recent migrants to the community. |
| Members of the travelling community | – | –Members of the population who are members of the travelling community. |
| Perinatal women. | – | –Members of the population who are pregnant or within a year of giving birth. |
| Lone-parents | – | –Members of the population who are raising children alone. |
| Individuals with physical disabilities | – | –Members of the population who have a physical disability. |
| Secondary school students | – | –Members of the population attending secondary school. |
| Remote workers | – | –Members of the population currently working from home. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We aim to collect survey data from at least 1,820 participants (20% response rate). We will conduct interviews with up to 5 members of each target cohort from the community ( older people, recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, and remote workers).
Key inclusion criteria (1 listed)
- Participants will be members of the urban town being studied.
Key exclusion criteria (1 listed)
- Non a member of the urban town being studied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Needs assessment survey
Time frame: January 2022-February 2022
An anonymous needs assessment survey (online and hard copies) will be conducted.
Needs assessment interivews
Time frame: January 2022-March 2022
Anonymous qualitative interviews will be conducted in conjunction with community liaison officers, over the telephone with up to 5 members of the following target groups - older people (65 years and older), recent migrants, members of the travelling community, perinatal women, lone-parents, individuals with physical disabilities, and remote workers.
Analysis
Time frame: March 2022- April 2022
Analysis of summary anonymous aggregate data will be used to inform future stages of this research.
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 16 Oct 2023.
- Background: PubMed 31329872Ng R, Sutradhar R, Yao Z, Wodchis WP, Rosella LC. Smoking, drinking, diet and physical activity-modifiable lifestyle risk factors and their associations with age to first chronic disease. Int J Epidemiol. 2020 Feb 1;49(1):113-130. doi: 10.1093/ije/dyz078.
- Background: PubMed 32716520Hyland P, Shevlin M, McBride O, Murphy J, Karatzias T, Bentall RP, Martinez A, Vallieres F. Anxiety and depression in the Republic of Ireland during the COVID-19 pandemic. Acta Psychiatr Scand. 2020 Sep;142(3):249-256. doi: 10.1111/acps.13219. Epub 2020 Aug 9.
- Background: PubMed 33207689Nearchou F, Flinn C, Niland R, Subramaniam SS, Hennessy E. Exploring the Impact of COVID-19 on Mental Health Outcomes in Children and Adolescents: A Systematic Review. Int J Environ Res Public Health. 2020 Nov 16;17(22):8479. doi: 10.3390/ijerph17228479.
- Background: PubMed 32504808Loades ME, Chatburn E, Higson-Sweeney N, Reynolds S, Shafran R, Brigden A, Linney C, McManus MN, Borwick C, Crawley E. Rapid Systematic Review: The Impact of Social Isolation and Loneliness on the Mental Health of Children and Adolescents in the Context of COVID-19. J Am Acad Child Adolesc Psychiatry. 2020 Nov;59(11):1218-1239.e3. doi: 10.1016/j.jaac.2020.05.009. Epub 2020 Jun 3.
- Background: PubMed 33634520Bailey T, Hastings RP, Totsika V. COVID-19 impact on psychological outcomes of parents, siblings and children with intellectual disability: longitudinal before and during lockdown design. J Intellect Disabil Res. 2021 May;65(5):397-404. doi: 10.1111/jir.12818. Epub 2021 Feb 25.
- Background: PubMed 32562349Ward MP. SARS-CoV-2, where to now? Transbound Emerg Dis. 2020 Jul;67(4):1411-1413. doi: 10.1111/tbed.13654. Epub 2020 Jun 19. No abstract available.
- Background: PubMed 31929010Fried L, Prohaska T, Burholt V, Burns A, Golden J, Hawkley L, Lawlor B, Leavey G, Lubben J, O'Sullivan R, Perissinotto C, van Tilburg T, Tully M, Victor C. A unified approach to loneliness. Lancet. 2020 Jan 11;395(10218):114. doi: 10.1016/S0140-6736(19)32533-4. No abstract available.
- Background: PubMed 27091846Valtorta NK, Kanaan M, Gilbody S, Ronzi S, Hanratty B. Loneliness and social isolation as risk factors for coronary heart disease and stroke: systematic review and meta-analysis of longitudinal observational studies. Heart. 2016 Jul 1;102(13):1009-16. doi: 10.1136/heartjnl-2015-308790. Epub 2016 Apr 18.
- Background: PubMed 32683689O'Connor DB, Aggleton JP, Chakrabarti B, Cooper CL, Creswell C, Dunsmuir S, Fiske ST, Gathercole S, Gough B, Ireland JL, Jones MV, Jowett A, Kagan C, Karanika-Murray M, Kaye LK, Kumari V, Lewandowsky S, Lightman S, Malpass D, Meins E, Morgan BP, Morrison Coulthard LJ, Reicher SD, Schacter DL, Sherman SM, Simms V, Williams A, Wykes T, Armitage CJ. Research priorities for the COVID-19 pandemic and beyond: A call to action for psychological science. Br J Psychol. 2020 Nov;111(4):603-629. doi: 10.1111/bjop.12468. Epub 2020 Jul 19.
- Individual participant dataSharing planned: No. Only summary aggregate data will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Healthy Lifestyle, run by Royal College of Surgeons, Ireland 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 1 inclusion and 1 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 16 Oct 2023. 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?
Needs assessment survey (time frame: January 2022-February 2022). 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 NCT05109026, which also lists 9 linked publications.
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 16 Oct 2023.