Condition category
Circulatory System
Date applied
06/12/2018
Date assigned
11/04/2019
Last edited
09/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Death rates have been falling in Ireland generally, but farmers show the slowest reduction of any socio-economic group. Irish farmers are are at high risk for cardiovascular disease (CVD, diseases of the heart and blood circulation system), the leading cause of death worldwide. Most CVD is caused by unhealthy lifestyle behaviours (including factors relating to work and the workplace) and are therefore preventable. CVD can reduce a person's ability to do physical activity and work, which can then undermine the profitability, competitiveness and sustainability of farming.
Farmers remain a 'hard to reach’ group in terms of engaging with health promotion initiatives. Whilst farmers respond positively to healthcare screening in places where the go as part of their farming activities, they are not as likely to commit to long-lasting sustainable health behaviour change. There is a gap in existing research in relation to what prompts farmers to adopt behaviour change to improve their health.
This study will investigate whether a tailored intervention is effective in prompting Irish farmers to adopt sustainable behaviour change to improve their health. Specifically, the study will investigate whether the programme results in effective follow-up use of GP services, sustainable cardiovascular health behaviour change, and reduced CVD risk.
Additionally, this study will compare and contrast two sub-groups of Irish farmers who will be recruited from two different settings (marts (livestock markets) and dairy co-ops). ‘Mart farmers’ tend to be largely involved in beef/cattle farming, to have smaller farm holdings and to be sole traders. ‘Co-op farmers’ tend to be largely engaged in dairy farming and are suppliers to agricultural processing companies. In this study the agricultural processor is Glanbia Ireland, a maker of cheese, butter and other dairy products. The recruitment of the farmers will take place in marts and Glanbia Ireland co-ops in the South-East, Midland, Mid-East and South-West regions of Ireland. The farmers take part in the health checks based on self-referral, meaning it is completely up to them whether they take up the offer of the health check.
This research has been awarded a Teagasc Walsh Fellowship. It will be carried out in partnership between the National Centre for Men’s Health at IT Carlow, Teagasc, the HSE, the Irish Heart Foundation (IHF) and Glanbia. The findings from this study will provide insight into the cardiovascular health status of Irish farmers and a better understanding of ways to encourage this group to improve their cardiovascular health by making changes to their lifestyle and health behaviours. The learnings will also inform decision-making on health behaviour change support systems for farmers using different approaches such as Teagasc knowledge transfer and extension workers, mart workers and Glanbia advisors.

Who can participate?
Male farmers aged over 18 years.

What does the study involve?
All participants will get a cardiovascular health check at baseline and at 52 weeks in a workplace (livestock marts or dairy co-ops). These cardiovascular health checks are carried out by a qualified nurse from the Irish Heart Foundation who will measure cholesterol and other lipids (fats) in blood, blood glucose, blood pressure, carbon monoxide in breath (for smokers), weight, height and waist measurement. The nurse will also collect information on medical history and health and lifestyle behaviours, including family history of diabetes, heart disease and/or stroke, last GP visit (including last cardiovascular health check), use of current medication for heart disease/diabetes (which medication and whether it is taken as prescribed), smoking (yes/no, how many), use of alcohol (yes/no, how many standard units a week, binge drinking), levels of physical activity (work-related, leisure), experienced stress. The cardiovascular health check also includes lifestyle counselling to suggest behaviour changes to improve health.
After the first health check, the participants are asked to take part in a face-to-face questionnaire and are offered a choice of three behaviour change support interventions to improve their cardiovascular health status:
1. M-health. This consists of general cardiovascular health-promoting text messages (three text messages per week for 4 months). Participants are asked to reply to a text message twice per month. M-health uses mobile and wireless technologies to support health objectives. While health promotion interventions based on text messaging are relatively new, evidence suggests that they are effective in relation to health behaviour change. M-health, and specifically text messaging, has been found to be an effective health intervention tool: it is fast, cheap and has a far reach within all socio-economic groups. Although farmers lag behind in their use of internet technology compared to the general Irish population, the majority of farmers, regardless of age, regularly use a mobile phone for talking and messaging.
2. Health coaching by phone. The health coach is an interactive intervention based on reflective listening and motivational interviewing that aims to encourage and support the participant with making and sustaining lifestyle changes to improve their cardiovascular health. This intervention is based on the theory of the Stages of Change. Health coaching supports people to gain personal insight, knowledge and confidence to engage in changing a behaviour by focusing on goal setting, personal empowerment and increased self-efficacy.
3. Health coaching in combination with M-health. This intervention group receives both interventions at the same time.
Participants may also choose to be part of a control group. Participants in this group take the cardiovascular health checks at baseline and 52 weeks also take part in a follow-up questionnaire by phone at 26 weeks after the health check. They do not receive any health behaviour change intervention.

What are the possible benefits and risks of participating?
The Farmers Have Hearts Programme reaches out to those who can be hard-to-reach and tend not to participate in preventive health, such as health checks. All farmers attending the livestock mart can get a free cardiovascular health check and brief lifestyle counselling, carried out by a qualified nurse from the Irish Heart Foundation. Results are provided during the health check and participants receive tailored hands-on practical advice on how to improve their cardiovascular health. In case of detected risk factors for CVD, participants are referred to their GP for further examination and (if needed) treatment. The cardiovascular health checks takes place in the workplace, the livestock mart, which is a space in which farmers feel safe and respected.
All participants receive an invitation for the free repeat cardiovascular health check, 52 weeks after the first health check. As part of the study, all participants are offered follow-up support by phone and/or text messaging offering personal tailored advice to encourage simple lifestyle changes to improve cardiovascular health. All members of the Farmers Have Hearts research team are Garda vetted and trained to look out for emotional and/or medical needs and advise participants to contact relevant support services. All communication as part of the study is strength-based, supportive and non-judgmental and in line with the Irish NALA (literacy) guidelines. All participants will receive information about national and local support services as well as the free Irish Heart Help number. All participants will receive for cardiovascular health booklets relevant to them and a copy of the health booklet ‘Staying fit for farming’ which contains health information tailored to the needs of farmers and includes useful addresses of support organisations.
We are mindful that participants in this study are largely from a lower socio-economic status group, have lower educational attainment and are middle-aged or older. The language used to explain the study, informed consent and questionnaires will need to be accessible, clear and understandable. All interventions are based on motivational interviewing. We also acknowledge that some participants might be nervous about the health check and that the results might cause worry. The health checks will be carried out by fully qualified Irish Heart Foundation nurses. Those with risk factors for CVD will be referred, as appropriate, to their GP by the nurse in line with standard Irish Heart Foundation operational procedures. Additionally, the nurse will flag up any identified need for emotional support identified during the health check and/or lifestyle counselling.
The principal researcher’s contact details will also be made available on the information sheet. Participants can make contact with the researcher if they feel the need to do so in relation to the study, their study participation and/or their health.

Where is the study run from?
Institute of Technology Carlow (Ireland)

When is the study starting and how long is it expected to run for?
May 2018 to December 2019

Who is funding the study?
Teagasc - The Agriculture and Food Development Authority (Ireland)

Who is the main contact?
1. Ms Diana van Doorn (public contact), diana.vandoorn@itcarlow.ie
2. Dr Noel Richardson (scientific contact, noel.richardson@itcarlow.ie

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Dr Noel Richardson

ORCID ID

http://orcid.org/0000-0002-2060-2338

Contact details

Kilkenny Road
Carlow
Ireland
Carlow
R93 V960
Ireland
00353 872860152
noel.richardson@itcarlow.ie

Type

Public

Additional contact

Ms Diana van Doorn

ORCID ID

http://orcid.org/0000-0003-2007-2020

Contact details

Kilkenny Road
Carlow
Ireland
Carlow
R93 V960
Ireland
00353 874176749
diana.vandoorn@itcarlow.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Assessing the effectiveness of a gendered approach to a health behaviour change programme designed to improve the health status of Irish livestock farmers.

Acronym

Farmers Have Hearts (FHH)

Study hypothesis

A workplace health check in combination with a follow-up support intervention specifically designed for farmers will be effective in prompting sustainable health behaviour change to improve farmers' cardiovascular health.
This study will adopt gender specific strategies to engage with a high-risk group (male farmers) and is underpinned by a national men’s health policy mandate. Whilst the principal focus of the study is therefore on male farmers, the brief interventions (health check including lifestyle advice) will be made available to both male and female farmers. Non-farmers will not be eligible to take part in the study.

Ethics approval

Ethics Committe of the Institute of Technology Carlow, 08/03/2018, ref: 205

Study design

Interventional longitudinal prospective non-randomised study with a quasi-experimental design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet.

Condition

Cardiovascular health

Intervention

All participants partake in a workplace (livestock marts or dairy co-ops) cardiovascular health check at baseline and at 52 weeks. These cardiovascular health checks are carried out by a qualified nurse from the Irish Heart Foundation and objectively measure cholesterol (full lipid profile), blood glucose, blood pressure, carbon monoxide (if applicable), anthropometric measurements (BMI, waist measurements). Additionally, data pertaining to self-reported health and lifestyle behaviours are gathered during the heart check: family history of diabetes, heart disease and/or stroke, last GP visit (including last cardiovascular health check), use of current medication for heart disease/diabetes (which medication and adherence), smoking (yes/no, how many), use of alcohol (yes/no, how many standard units a week, binge drinking), levels of physical activity (work related, leisure), experienced stress. The cardiovascular health check also includes a lifestyle counselling component.

After the health check, the participants are asked to take part in a face-to-face baseline questionnaire and are offered a choice of three behaviour change support interventions to improve their cardiovascular health status:
1. M-health. This intervention consists of general cardiovascular health-promoting text messages (three text messages per week for 4 months). Participants are asked to reply to a text message twice per month.
2. Health coaching by phone. The health coach is an interactive intervention based on reflective listening and motivational interviewing which aims to encourage and support the participant with making and sustaining lifestyle changes to improve their cardiovascular health. This intervention is based on the theory of the Stages of Change.
3. Health coaching in combination with M-health. This intervention group receives both interventions simultaneously.

Participants may also choose to be part of a control group. Participants in this group partake in the cardiovascular health checks at baseline and 52 weeks and also take part in a follow-up questionnaire by phone at 26 weeks after the health check. They do not receive any health behaviour change intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Use of GP services after referral. This will be measured by self-report during follow-up questionnaires at Week 26 (by phone) after the health check and Week 52 (face-to-face questionnaire).
2. Sustainable health behaviour change specifically in relation to weight reduction/weight management, physical activity, smoking, stress management and alcohol consumption. Lifestyle behaviour change will be measured by self-report during follow-up questionnaires at Week 26 (by phone) after the health check and Week 52 (face-to-face questionnaire). Additionally, lifestyle changes will be measured as part of the health coach intervention.
3. Cardiovascular health check at baseline and 52 weeks, including full lipid profile, blood glucose, blood pressure, anthropometric measurements (BMI and waist) and self-reported life style components such as alcohol consumption, smoking, stress, physical activity and sedentary behaviours.

Secondary outcome measures

1. Socio-cultural influences that support/inhibit farmers from engaging in health behaviour change. This will be assessed in a qualitative sub-study based on interviews.
2. Socio-cultural context that shapes the relationship between farming and cardiovascular health. This will be assessed in a qualitative sub-study based on interviews.
3. Engagement with a health behaviour change programme within two sub-groups of farmers (dairy and livestock farmers) assessed by self-report as part of the follow-up questionnaires at Week 26 (by phone) and Week 52 (face-to-face)

Overall trial start date

01/10/2017

Overall trial end date

01/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Male farmers aged ≥18 years

Participant type

Mixed

Age group

Adult

Gender

Male

Target number of participants

The total sample size will 960; divided in 480 'mart' (livestock) farmers and 480 'co-op' (dairy) farmers.The four-armed intervention will have the following composition and sample size: 1. Control group (n=240); 2. Health coach intervention group (n=240), 3. M-health group (n=240, 4. Health coach and M-health group (n=240).

Total final enrolment

868

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

17/05/2018

Recruitment end date

08/04/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

Glanbia Countrylife
Shandon St Abbeyside Dungarvan Co. Waterford
Waterford
X35 KA99
Ireland

Trial participating centre

Glanbia Countrylife
Clonroche Enniscorthy Co. Wexford
Clonroche
Y21 FW72
Ireland

Trial participating centre

Glanbia Co-op Killenaule
Kilenaule Thurles Co. Tipperary
Killenaule
E41 HW27
Ireland

Trial participating centre

Glanbia Countrylife Kilmaedan
Adamstown Kilmeaden Co. Waterford
Kilmaedan
R680
Ireland

Trial participating centre

Glanbia Countrylife Campile
Main St Ballyvelig Campile Co. Wexford
Campile
Y34 H521
Ireland

Trial participating centre

Glanbia Co-op Goresbridge
Barrow Mount Dr Barrowmount Goresbridge Co. Kilkenny
Goresbridge
R95 C563
Isle of Man

Trial participating centre

Glanbia Countrylife Donaghmore
Donaghmore Portlaoise Co. Laois
Donaghmore
R32 XY61
Ireland

Trial participating centre

Glanbia countrylife Monasterevin
Cowpasture Barraderra Monasterevin Co. Kildare
Monasterevin
W34 PF50
Ireland

Trial participating centre

Glanbia Co-op Inch
Inch Gorey Co. Wexford
Inch
Y25 W894
Ireland

Trial participating centre

Glanbia Co-op Castlelyons
Castlelyons Bridebridge Fermoy Co. Cork
Castlelyons
P61 K156
Ireland

Trial participating centre

Glanbia Countrylife Tullamore
Spollanstown Industrial Estate Tullamore Co. Offaly
Tullamore
R35 K820
Ireland

Trial participating centre

Glanbia Agribusiness Ballitore
Ballitore Athy Co. Kildare,
Ballitore
R14 CH05
Ireland

Trial participating centre

Glanbia Agribusiness Bennettsbridge
Kilkenny Rd Bennettsbridge Co. Kilkenny,
Bennettsbridge
R95 E02D
Ireland

Trial participating centre

Glanbia Agribusiness Piltown
Banagher Piltown Co. Kilkenny
Piltown
E32 WD21
Ireland

Trial participating centre

Glanbia Agribusiness Athboy
Mullaghstones Clifton Athboy, Co. Meath
Athboy
C15 HE33
Ireland

Trial participating centre

Carnew Mart
Lower Main Street Carnew Co. Wicklow
Carnew
Y14 NN72
Ireland

Trial participating centre

Roscrea Mart
Townparks Roscrea Co. Tipperary
Roscrea
Y14 NN72
Ireland

Trial participating centre

Tullamore Cattle Mart
GVM Mart, Arden Rd Tullamore Co. Offaly
Tullamore
R35 XK35
Ireland

Trial participating centre

Roscrea Cattle Mart
Parkmore Industrial Estate Roscrea Co. Tipperary
Roscrea
E53 F223
Ireland

Trial participating centre

KANTURK CO-OP MARTS LTD.
Percival St Kanturk Co. Cork
Kanturk
P51 HR29
Ireland

Trial participating centre

Cahir Mart
Camus Road Cashel Co Tipperary
Cahir
E25 XP66
Ireland

Trial participating centre

Blessington Mart
20 Main Street Blessington Co. Wicklow
Blessington
W91XH60
Ireland

Trial participating centre

Tullow Mart
Barrack St Tullowphelim Tullow Co. Carlow
Tullow, Co. Carlow
N/A
Ireland

Trial participating centre

Fermoy Mart
Rath-Healy Fermoy Co.Cork
Fermoy
N/A
Ireland

Trial participating centre

Carnacross Mart
Kells Business Park Cavan Rd Meenlagh Kells Co. Meath
Kells
N/A
Ireland

Trial participating centre

Baltinglass Mart
East Baltinglass Co Wicklow
Baltinglass
N/A
Ireland

Trial participating centre

Enniscorthy Mart
Old Dublin Rd Blackstoops Enniscorthy Co. Wexford
Enniscorthy
Y21 72D0
Ireland

Sponsor information

Organisation

Institute of Technology Carlow

Sponsor details

Kilkenny Road
Carlow
Carlow
R93V960
Ireland
+353 59 9175000
Noel.richardson@itcarlow.ie

Sponsor type

University/education

Website

https://www.itcarlow.ie

Funders

Funder type

Government

Funder name

Teagasc

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Ireland

Funder name

Health Service Executive

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Glanbia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The following deliverables/outputs will be developed from the project proposal:
1. National and international conference presentations
2. Five articles published in international peer-reviewed journals (e.g. Journal of Remote and Rural Health, Journal of Health Promotion, Journal of Occupational Health, and Journal of Agromedicine). It is expected that the first paper, describing baseline characteristics, will be published in 2019.
3. There will be yearly interim reports made available and a final report for the Institute of Technology Carlow and Teagasc. An overall report with the main findings of the study will be made available for all stakeholders in this study.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/11/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/05/2019: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/04/2019 to 08/04/2019. 2. The overall trial end date was changed from 31/12/2019 to 01/05/2020. 3. The intention to publish date was changed from 01/08/2019 to 01/11/2019. 4. The total final enrolment number was added.