Plain English Summary
Background and study aims
Men in Ireland die younger and have higher death rates than women for most of the leading causes of death at all ages. Physical activity could help prevent many of the chronic conditions affecting men. Physical activity levels in men reduce with age, which is paralleled by an increasing levels of obesity. Supporting men to modify their health behaviors poses unique challenges to service providers. Men on the Move is a physical activity programme that is aimed at adult men to support them to become active, have fun and improve their fitness levels. It involves twice weekly structured physical activity sessions over 12 weeks that are led by a qualified instructor to a level and pace that suits you. Workshops on nutrition and well-being for men will also be delivered during the 12-week programme. The aim of this study is to determine whether the Men on the Move programme improves the physical fitness, weight and general health and lives of the men who attend.
Who can participate?
Men who are not meeting the national guideline levels of physical activity
What does the study involve?
Participants in the intervention group attend the the 12-week Men on the Move programme. Participants in the comparison group receive a free health check and an information booklet. As part of the evaluation we ask participants questions about their health and measure their height, weight, waist circumference, BMI and fitness at the start and the end of the programme and in February and August 2016.
What are the possible benefits and risks of participating?
This study will enable us to find out how this type of programme may be helpful to men. By doing this, we hope to be able to deliver this programme to more men across the country. The primary risk for participants is the stress associated with the possibility of individuals being identifiable in the presentation of findings. Steps have been taken to off-set these risks and have been approved by the WIT research ethics committee. In respect to the physical activity element of the Men on the Move programme, all participants complete a physical activity readiness questionnaire at the beginning the programme to determine the safety or possible risk of exercising based upon their responses to specific health history questions. These questionnaires are reviewed and where required participants are referred to their GP before starting the programme.
Where is the study run from?
Waterford Institute of Technology (Ireland)
When is the study starting and how long is it expected to run for?
September 2015 to August 2016
Who is funding the study?
Health Service Executive (HSE), Cork Local Sports Partnership (LSP), Donegal LSP, Dublin LSP, Galway LSP, Kilkenny LSP, Limerick LSP, Mayo LSP, Waterford LSP, Irish Heart Foundation, Men's Development Network
Who is the main contact?
1. Dr Paula Carroll (pcarroll@wit.ie)
2. Alex Donohoe (ADonohoe@wit.ie)
Trial website
Contact information
Type
Public
Primary contact
Dr Paula Carroll
ORCID ID
http://orcid.org/0000-0001-8465-4535
Contact details
G06
Health Sciences Building
Waterford Institute of Technology
Cork Road Campus
Waterford
000
Ireland
+353 (0)51 834141
pcarroll@wit.ie
Type
Scientific
Additional contact
Miss Alex Donohoe
ORCID ID
Contact details
G03
Health Sciences Building
Waterford Institute of Technology
Cork Road Campus
Waterford
000
Ireland
+353 (0)51 834141
ADonohoe@wit.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of a 12-week gender-sensitized physical activity intervention for men on biopsychosocial health measures
Acronym
MoM
Study hypothesis
To determine whether the MoM programme impacted the physical fitness, weight status and general health and lives of the men who attend.
Ethics approval
Research Ethics Committee of Waterford Institute of Technology, 21/04/2015, ref: 15/Dept-HSES/13
Study design
Interventional multi-centre controlled trial
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
Physical activity, mental well-being, obesity and physical fitness
Intervention
The intervention will comprise of structured group exercise [2*1 hour weekly], two facilitated workshops [diet and well-being], an information booklet with a PA log, a 5Km celebration event at 12 weeks, a pedometer for independent PA sessions and phone contact from local service providers. The core components of the structured group exercise [e.g. cardiovascular and strength and conditioning training] will be standardised across all centres. However, in keeping with good practice, some flexibility will be catered for within groups; minor tailoring of the programme may occur so that these core components are achieved in a way that best suits the men’s needs.
The comparison group will receive a free health check [time to complete 1 mile, BMI, waist circumference, BP and cholesterol] and an information booklet.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Physical fitness, measured using a 1 mile test (mins and dec mins) at baseline, 12, 26 and 52 weeks
2. Weight, measured using a seca 813 digital weighing scales (kg) at baseline, 12, 26 and 52 weeks
3. BMI, calculated using a mathematical formula (weight/height2 [kg/m2]) at baseline, 12, 26 and 52 weeks
4. Waist circumference, measured using measuring tape (cm) at baseline, 12, 26 and 52 weeks
5. General health history and perception, measured using a questionnaire adapted from SLÁN 2007 [Barry et al., 2009] and Premier League Health [White et al., 2012] at baseline 12, 26 and 52 weeks
6. Dietary habits, measured using a Questionnaire; adapted from Premier League Football health initiatives evaluation [White at al., 2012] at baseline, 12, 26 and 52 weeks
7. Alcohol habits, measured using a questionnaire adapted from SLÁN [Barry et al., 2009] and Premier League Football health initiatives evaluation [White et al., 2012] at 12, 26 and 52 weeks
8. Smoking habits, measured using a questionnaire adapted from SLÁN [Barry et al., 2009] and Premier League Football [White et al., 2012] health initiatives evaluation at 12, 26 and 52 weeks
9. Mental well-being, measured using a questionnaire adapted from The Warwick-Edinburgh Mental Well-being Scale at baseline, 12, 26 and 52 weeks
10. Social integration, measured using a questionnaire (Berkman-Syme social network index) at baseline, 12, 26 and 52 weeks
Secondary outcome measures
1. Cost effectiveness analysis of the intervention effects - data collected by within trial analysis [cost calculation of resources inputted into the programme, objective measures of weight, BMI and waist circumference, and time to do 1 mile]
2. Broader impacts of the programme on the health and lives of the participants - data collected through focus groups and interviews with participants
3. An investigation of the sustainability of the model of community-based health promotion for men - data collected through focus groups and interviews with service providers
Overall trial start date
01/09/2015
Overall trial end date
31/08/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Currently inactive men [not meeting national PA guidelines]
2. Complete Physical Activity Readiness Questionnaire
3. Not participated in a MoM programme before
Participant type
All
Age group
Adult
Gender
Male
Target number of participants
A total of 720 participants were targeted with 360 in each arm [Intervention and Control]. To date, the trialists have recruited 492 and 426 participants in the intervention and control groups, respectively. Each group is spread across 12 centers with at least 30 men in each center.
Participant exclusion criteria
Non-proficiency in the English language
Recruitment start date
01/09/2015
Recruitment end date
17/09/2015
Locations
Countries of recruitment
Ireland
Trial participating centre
Falcarragh
Co. Donegal
-
Ireland
Trial participating centre
Lifford
Co. Donegal
-
Ireland
Trial participating centre
Rathmullen
Co. Donegal
-
Ireland
Trial participating centre
Ballina
Co. Mayo
-
Ireland
Trial participating centre
Ballaghderren
Co. Mayo
-
Ireland
Trial participating centre
Crossmolina
Co. Mayo
-
Ireland
Trial participating centre
Waterford City
Regional Sports Centre,
Co. Waterford
-
Ireland
Trial participating centre
Dungarvan
Co. Waterford
-
Ireland
Trial participating centre
Lismore
Co. Waterford
-
Ireland
Trial participating centre
Oughterard
Co. Galway
-
Ireland
Trial participating centre
Doughiska
Co. Galway
-
Ireland
Trial participating centre
Ballinasloe
Co. Galway
-
Ireland
Trial participating centre
Rialto
Co. Dublin
-
Ireland
Trial participating centre
Coolook
Co. Dublin
-
Ireland
Trial participating centre
Terenure
Co. Dublin
-
Ireland
Trial participating centre
Ballyhea
Co. Cork
-
Ireland
Trial participating centre
Inniscara
Co. Cork
-
Ireland
Trial participating centre
Dunmanway
Co. Cork
-
Ireland
Trial participating centre
Desmond league
Co. Limmerick
-
Ireland
Trial participating centre
Auginish Diving Club
Co. Limerick
-
Ireland
Trial participating centre
Limmerick Swim Club
Co. Limmerick
-
Ireland
Trial participating centre
Richmond Rugby Club
Co. Limmerick
-
Ireland
Trial participating centre
Thomastown
Co. Kilkenny
-
Ireland
Trial participating centre
Castlecomer
Co. Kilkenny
-
Ireland
Trial participating centre
O' Loughlin Gaels
Co. Kilkenny
-
Ireland
Sponsor information
Organisation
Centre for Health Behaviour Research (Ireland)
Sponsor details
Waterford Institute of Technology
Cork Road campus
Waterford
000
Ireland
+353 (0)51 834141
PCarroll@wit.ie
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Health Service Executive (HSE) [Health Promotion and Improvement Division]
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cork Local Sports Partnership (LSP), Donegal LSP, Dublin LSP, Galway LSP, Kilkenny LSP, Limerick LSP, Mayo LSP, Waterford LSP
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Irish Heart Foundation
Alternative name(s)
IHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Ireland
Funder name
Men's Development Network
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
It is envisaged there will be numerous publications arising from this research study and the following are currently under development:
1. Study protocol and procedures
2. Methods paper that looks at the lessons learned from implementing a national practitioner based action research project
3. A baseline profile of the men who participated in this study that will also look at the relationship between physiological and psychosocial health indicators
4. The impact of a 12-week PA programme for men on the biopsychosocial health indicators (Quantitative Data).
5. The broader impact of the programme on men's health and lives (Qualitative Data)
6. The factors that contribute to a sustainable model of community based health promotion for men
7. The impact of practitioner experiences of engaging with men on the MoM programme on future practice
8. The cost effectiveness of the programme
Intention to publish date
20/06/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2018 protocol in: http://pubs.sciepub.com/jpar/3/1/4/index.html
2018 process evaluation in: http://www.ijmsch.com/index.php/IJMSCH/article/view/14
2018 pre-adoption characteristics in: https://www.ncbi.nlm.nih.gov/pubmed/30137402