Condition category
Not Applicable
Date applied
13/11/2015
Date assigned
25/11/2015
Last edited
23/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
Dr Paula Carroll (pcarroll@wit.ie)
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, 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 below 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 measures

1. Physical fitness - measured using a 1 mile test (mins and dec mins) and collected at baseline, 12, 26 and 52 weeks
2. Weight - measured using a seca 813 digital weighting scales (kg) and collected at baseline, 12, 26 and 52 weeks
3. BMI - calculated using a mathematical formula (weight/height2 [kg/m2] and collected at baseline, 12, 26 and 52 weeks
4. Waist Circumference - measured using measuring tape (cm) and collected 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]. Collected 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]. Collected 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]. Collected 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. Collected at 12, 26 and 52 weeks
9. Mental well-being – measured using a questionnaire; adapted from The Warwick-Edinburgh Mental Well-being Scale. Collected at baseline, 12, 26 and 52 weeks
10. Social Integration – measured using a questionnaire (Berkman-Syme social network index). Collected 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

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, we 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

http://www.wit.ie/research/centres_and_groups/research_groups/health_sciences/centre_for_health_behaviour_research

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

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes